Vol. 03 No 03 Jul/Aug/Sep. 2020

ISSN 2595-3192

BrJPBRAZILIAN JOURNAL OF PAIN Vol. 03 No 03 Jul/Aug/Sep. 2020

capa brjp 2018.indd 1 08/05/2018 18:29:44 Alívio prolongado da dor 1-4

Opioide com evidências de efetividade ao ser empregado no tratamento da Rápido inicio de ação 7 no tratamento da fibromialgia. dor neuropática. 6 h1,2 12 efetivo

APRESENTAÇÕES¹: 10 cápsulas duras 50mg, solução oral com 10 mL (100mg/mL), retard: 10 comprimidos revestidos de liberação prolongada 100mg. MODERADA

TRAMADON® É UM MEDICAMENTO. DURANTE SEU USO, NÃO DIRIJA VEÍCULOS OU OPERE MÁQUINAS, POIS SUA AGILIDADE E ATENÇÃO PODEM ESTAR PREJUDICADAS. CONTRAINDICAÇÃO: PACIENTES EM TRATAMENTO COM INIBIDORES DA MAO OU QUE FORAM TRATADOS COM ESSES FÁRMACOS NOS ÚLTIMOS 14 DIAS.INTERAÇÃO MEDICAMENTOSA: FÁRMACOS QUE REDUZAM O LIMIAR PARA CRISES CONVULSIVAS.

Referências Bibliográficas: 1. Bula Tramadon® e Tramadon® Retard. Reg. MS nº 1.0298.0261. 2. Grond S, Sablotzki A. Clinical pharmacology of tramadol. Clin Pharmacokinetic. 2004; 43(13):879-923. 3. Kahan M, Mailis-Gagnon A, Wilson L, Srivastava A; National Opioid Use Guideline Group. Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population. Can Fam Physician. 2011;57(11):1257-66. 4. Klotz U. Tramadol-the impact of its pharmacokinetic and pharmacodynamics properties on the clinical management of pain. Arzneimittelforschung. 2003;53(10):681-7. 5. World Anti-Doping Agency. Prohibited List January 2020. World Anti-Doping Code: International Standard, 2019. 6. Jefferies K. Treatment of neuropathic pain. Semin Neurol. 2010;30(4):425-32. 7. Rahman A, Underwood M, Carnes D. Fibromyalgia. BMJ. 2014;348:g1224. TRAMADON® cloridrato de tramadol - solução oral 100 mg/mL, USO ORAL. USO ADULTO E PEDIÁTRICO ACIMA DE 1 ANO - cápsula dura 50 mg, USO ORAL. USO ADULTO E PEDIÁTRICO ACIMA DE 12 ANOS. TRAMADON® RETARD cloridrato de tramadol - comprimidos revestidos de liberação prolongada 100 mg, USO ORAL. USO ADULTO E PEDIÁTRICO ACIMA DE 12 ANOS. INDICAÇÕES: alívio da dor de intensidade moderada a grave. CONTRAINDICAÇÕES: hipersensibilidade ao tramadol ou qualquer componente das fórmulas; intoxicação aguda por álcool, hipnóticos, analgésicos, opioides e outros psicotrópicos; pacientes em tratamento ou tratados com inibidores da MAO (monoamina oxidase) nos últimos 14 dias; epilepsia não controlada adequadamente com tratamento; substituto na abstinência de narcóticos. Este medicamento não deve ser utilizado por mulheres grávidas sem orientação médica ou do cirurgião-dentista. ADVERTÊNCIAS E PRECAUÇÕES: dependência aos opioides, pacientes com tendência à dependência ou ao abuso de medicamentos, pacientes sensíveis aos opioides, ferimentos na cabeça, distúrbios do nível de consciência de origem não estabelecida, pressão intracraniana aumenta- da, choque, distúrbios da função ou do centro respiratório, pacientes com epilepsia ou susceptíveis a convulsões (relatadas convulsões em pacientes recebendo tramadol nas doses recomendadas). Em longo prazo, pode-se desenvolver tolerância e dependência física e psicológica. Durante o tratamento, o paciente não deve dirigir veículos ou operar máquinas, pois sua habilidade e atenção podem estar prejudicadas. Gravidez: atravessa a barreira placentária, não deve ser utilizado durante a gravidez; no neonato pode induzir alterações na taxa respiratória e no uso crônico levar a sintomas de abstinência. Lactação: uso não recomendado. Solução oral: este medicamento contém SACAROSE. INTERAÇÕES MEDICAMENTOSAS: inibidores da MAO, carbamazepina, ondansetrona, álcool e depressores do Sistema Nervoso Central (SNC), inibidores seletivos da recaptação de serotonina, inibidores da recaptação de serotonina e norepinefrina, antidepressivos tricíclicos, antipsicóticos, fármacos que diminuem o limiar para crises convulsivas, serotoninérgicos, derivados cumarínicos e inibidores do CYP3A4. POSOLOGIA: ajustar dose à intensidade da dor e à sensibilidade individual do paciente. Dose total diária de 400 mg de cloridrato de tramadol não deve ser excedida, exceto em circunstâncias clínicas especiais. TRAMADON® Solução Oral: em adultos e adolescentes acima de 12 anos de idade, 50-100 mg a cada 4 ou 6 h. Em crianças acima de 1 ano de idade, dose única: 1-2 mg/kg de peso corporal. Não exceder dose diária total de 8mg/kg de peso corporal ou 400 mg (o que for menor). 1 gota = 2,5 mg. TRAMADON® Cápsula Dura (adultos e adolescentes a partir de 12 anos): 50-100 mg a cada 4 ou 6 h. TRAMADON® RETARD (adultos e adolescentes a partir de 12 anos): até 200 mg 2x/dia. Idosos (acima de 75 anos) e Insuficiência Renal e/ou Hepática: considerar intervalos maiores entre as doses de acordo com os requerimentos dos pacientes. Pacientes com insuficiência renal e/ou hepática grave não devem tomar TRAMADON® RETARD. REAÇÕES ADVERSAS: Muito Comum: náusea, tontura. Comum: dor de cabeça, sonolência, vômito, constipação, boca seca, hiperidrose, fadiga. Incomum: regulação cardiovascular (palpitação, taquicardia; hipotensão postural ou colapso cardiovascular), ânsia de vômito, desconforto gastrintestinal, diarreia, reações dérmicas (ex: prurido, rash, urticária). SUPERDOSE: miose, vômito, colapso cardiovascular, distúrbios de consciência podendo levar ao coma, convulsões e depressão respiratória à parada respiratória. Aplicar medidas de emergência gerais. Naloxona se depressão respiratória, diazepam se convulsão. APRESENTAÇÕES: TRAMADON® Solução Oral: embalagem contendo 1 frasco gotejador com 10 mL; Cápsula Dura: embalagem contendo 10 ou 100 cápsulas. TRAMADON® RETARD: embalagem contendo 10 comprimidos revestidos. Para mais informações, vide bula do medicamento. CRISTÁLIA - Produtos Químicos Farmacêuticos Ltda. - Farm. Resp.: Dr. José Carlos Módolo - CRF-SP nº 10.446 - Rod. Itapira-Lindóia, km14, Itapira-SP - CNPJ n° 44.734.671/0001-51 - Indústria Brasileira - SAC: 0800 7011918 - nº do Lote, Data de Fabricação e Prazo de Validade: Vide Embalagem. CLASSIFICAÇÃO: VENDA

AN-UVF-TRM-1-1º-15-JAN/2020 SOB PRESCRIÇÃO MÉDICA – SÓ PODE SER VENDIDO COM RETENÇÃO DA RECEITA. MEDICAMENTO SIMILAR EQUIVALENTE AO MEDICAMENTO DE REFERÊNCIA. Reg. MS Nº 1.0298.0261.

Material de divulgação exclusiva aos profissionais de saúde habilitados a prescrever medicamentos. CONTENTS

Volumen 3 – nº 3 EDITORIAL July to September, 2020 Revised definition of pain after four decades______197 Trimestral Publication Definição de dor revisada após quatro décadas Josimari Melo DeSantana, Dirce Maria Navas Perissinotti, José Oswaldo de Oliveira Junior, Luci SOCIEDADE BRASILEIRA PARA O Mara França Correia, Célia Maria de Oliveira, Paulo Renato Barreiros da Fonseca ESTUDO DA DOR DIRECTORY ORIGINAL ARTICLES Biennium 2020-2021 Evaluation of the keratinocytes or fibroblasts culture supernatant in an inflammatory hyperalgesia model______199 President Avaliação do sobrenadante da cultura de queratinócitos ou fibroblastos em modelo de hiperalgesia Paulo Renato Barreiros da Fonseca inflamatória http://lattes.cnpq.br/9099397240334208 Cíntia Ávila Souza, Gilson Gonçalves dos Santos, Felipe Hertzing Farias, Eli Ávila Souza Júnior, Vice-President Carlos Amilcar Parada José Oswaldo de Oliveira Junior http://lattes.cnpq.br/6744087111028320 Effects of neural mobilization on individuals with chronic low back pain______205 Scientific Director Efeito da mobilização neural em indivíduos com dor lombar crônica Luci Mara França Correia Marina Ramos, Caio A. H. Cruz, Moises F. Laurentino, Hazem Adel Ashmawi, Fabio M. Santos, http://lattes.cnpq.br/8878925882317970 Marucia Chacur Administrative Director Green medicinal clay in the treatment of the unspecified lumbar pain: clinical trial___213 Dirce Maria Navas Perissinotti Argila medicinal verde no tratamento da dor lombar inespecífica: ensaio clínico http://lattes.cnpq.br/4257309602330961 Mariana Terezinha Delfino, Graciela Mendonça da Silva de Medeiros, Aline Daiane Schlindwein Treasurer Josimari Melo de Santana Pain intensity and immediate puerperal discomforts ______217 http://lattes.cnpq.br/9819654988177433 Intensidade de dor e desconfortos puerperais imediatos Secretary Thais do Amaral Tomasoni, Jordana Barbosa Silva, Thalita Cristina Wolff Bertotti, Jessica Perez, Célia Maria de Oliveira Raciele Ivandra Guarda Korelo, Rubneide Barreto Silva Gallo http://lattes.cnpq.br/9391711154551929 Relationship between symptoms and imagenological signs of degenerative Sociedade Brasileira para o Estudo da Dor temporomandibular joint disorders using the Research Diagnostic Criteria for Av. Conselheiro Rodrigues Alves, 937 Temporomandibular Disorders and cone-beam computed tomography______222 Cj. 2 – Vila Mariana Relação entre sintomas e sinais imagenológicos das disfunções degenerativas da articulação 04014-012 São Paulo, SP temporomandibular com o Research Diagnostic Criteria for Temporomandibular Disorders e a Fone: 11 5904-2881/3959 tomografia computadorizada de feixe cônico www.dor.org.br Bruno Moreira da-Silva, Rafael de Almeida Spinelli Pinto, Letícia Ladeira Bonato, Arnaud Alves E-mail: [email protected] Bezerra-Júnior, Eduardo Grossmann, Luciano Ambrósio Ferreira Predictive factors of chronic lower back pain risk in women: population-based study _ 228 Quotations of Brazilian Journal of Pain Fatores preditivos de risco de lombalgia crônica em mulheres: estudo de base populacional shall be abbreviated to BrJP. Patrícia Cilene Freitas Sant´Anna, Guilherme Watte, Anderson Garcez, Stephan Altmayer, Maria Teresa Anselmo Olinto, Juvenal Soares Dias da Costa BrJP is not responsible whatosever by opinions. Interference of the Carpal Tunnel syndrome symptoms on occupational performance_ 234 Interferência dos sintomas da síndrome do Túnel do Carpo no desempenho ocupacional Advertisements published in this edition do no Kátine Marchezan Estivalet, Carmine Thomas, Aline Sarturi Ponte, Dyannder da Silva Porciuncula generate conflict of interests. Pinto, Miriam Cabrera Corvelo Delboni

Intensity of pain, disability and psychosocial factors in women with chronic pelvic pain: cross-sectional study______239 Indexada na SciELO Indexada na LILACS Indexada na Latindex Intensidade da dor, incapacidade funcional e fatores psicossociais em mulheres com dor pélvica crônica: um estudo transversal Publication edited and produced by Jennifer Nogueira Rocha, Luiz Eduardo de Castro, Virgínia Martello Riccobene, Michele Souza MWS Design – Phone: (055) 11 98767-6188 Menezes Autran, Leandro Alberto Calazans Nogueira, Felipe José Jandre dos Reis

Journalist In Charge Recording acute pain in hospitalized patients______245 Marcelo Sassine - Mtb 22.869 O registro da dor aguda em pacientes hospitalizados Art Editor Amanda Brassaroto Gimenes, Camila Takáo Lopes, Alfredo José Alves Rodrigues-Neto, Marina de Anete Salviano Góes Salvetti SCIENTIFIC EDITOR José Geraldo Speciali Relationship of anteversion of the femoral neck with patellofemoral pain syndrome in Irimar de Paula Posso University of Sao Paulo, Ribeirao Preto, University of Sao Paulo, Sao Paulo, SP, Brazil – [email protected] young women not practicing regular physical activity______249 SP, Brazil – [email protected]. https://orcid.org/0000-0002-1148-1212 https://orcid.org/0000-0003-0337-2531 http://lattes.cnpq.br/6919225958713920 Relação entre a anteversão de colo do fêmur e a síndrome da dor patelofemoral em mulheres jovens http://lattes.cnpq.br/5789900900585872 José Oswaldo Oliveira Junior não praticantes de atividade física regular University of Sao Paulo, Sao Paulo, SP, COEDITORS Brazil – [email protected] Alexandre Otilio Pinto-Junior, Yuri Rafael dos Santos Franco, Quiteria Maria Wanderley Rocha Célia Maria de Oliveira https://orcid.org/0000-0003-1748-4315 Federal University of Minas http://lattes.cnpq.br/6744087111028320 Gerais, Belo Horizonte, MG, José Tadeu Tesseroli de Siqueira Cross-cultural adaptation and content validity evidence of the Brazilian version of the Brazil – [email protected] University of Sao Paulo, Sao Paulo, SP, https://orcid.org/0000-0002-1937-7364 Brazil – [email protected] Nociception Coma Scale-revised______253 http://lattes.cnpq.br/9391711154551929 https://orcid.org/0000-0002-9721-1634 Adaptação transcultural e evidência de validade de conteúdo da versão brasileira da Nociception Dirce Maria Navas Perissinotti http://lattes.cnpq.br/9759563517399484 University of Sao Paulo, Sao Paulo, Karina Gramani Say Coma Scale-revised SP, Brazil – [email protected] Federal University of Sao https://orcid.org/0000-0002-0346-1190 Carlos, Sao Carlos, SP – Brazil – Mariana Bucci Sanches, Cristiane Vias França Silva, Yasmin Mohamed Ali, Marcio Matsumoto, http://lattes.cnpq.br/4257309602330961 [email protected] João Valverde Filho, Marina de Góes Salvetti Eduardo Grossmann https://orcid.org/0000-0002-2451-8109 Federal University of Rio Grande http://lattes.cnpq.br/5096508613057074 do Sul, Porto Alegre, RS, Brazil Kátia Nunes Sá REVIEW ARTICLES – [email protected] Bahia School of Medicine and http://orcid.org/0000-0002-1238-1707 Public Health, Salvador, BA, Influence of the Pilates method on quality of life and pain of individuals with http://lattes.cnpq.br/4470378345964718 Brazil – [email protected]  Josimari Melo de Santana https://orcid.org/0000-0002-0255-4379 fibromyalgia: integrative review______258 Federal University of Sergipe, Aracaju, http://lattes.cnpq.br/4313045041004715 Influência do método Pilates na qualidade de vida e dor de indivíduos com fibromialgia: revisão SE, Brazil – [email protected] Luci Mara Franca Correia https://orcid.org/0000-0003-1432-0737 Sao Leopoldo Mandic Dental integrativa http://lattes.cnpq.br/9819654988177433 Research Center, Curitiba, PR, Brazil Juliana Barcellos de Souza – [email protected] Bruna Lira Brasil Cordeiro, Igor Henriques Fortunato, Fabiano Ferreira Lima,  Federal University of Santa https://orcid.org/0000-0002-4977-255X Rinaldo Silvino Santos, Manoel da Cunha Costa, Aline Freitas Brito Catarina, Florianopolis, SC, Brazil http://lattes.cnpq.br/8878925882317970 – [email protected] Mirlane Guimaraes de Melo Cardoso https://orcid.org/0000-0003-4657-052X Federal University of Amazonas, Scales for the assessment of pain in the intensive care unit. Systematic review_____ 263 http://lattes.cnpq.br/0009123389533752 Manaus, AM, Brazil – Lia Rachel Chaves do Amaral Pelloso [email protected]  Escalas para a avaliação da dor na unidade de terapia intensiva. Revisão sistemática Federal University of Mato https://orcid.org/0000-0001-9739-8235 Grosso, Cuiaba, MT, Brazil – http://lattes.cnpq.br/1663863759459785 Tássia Catiuscia Nascimento Silva da Hora, Iura Gonzalez Nogueira Alves Oscar César Pires [email protected] https://orcid.org/0000-0001-9594-9371 University of Taubate, Taubate, SP, Brazil – [email protected] Effect of mesenchymal stem cells on the regeneration of structures associated with http://lattes.cnpq.br/1267225376308387  Maria Belen Salazar Posso https://orcid.org/0000-0002-7033-0764 http://lattes.cnpq.br/2929971233764932 temporomandibular joint: narrative review______275 Christian University Foundation, Paulo Cesar Rodrigues Conti Pindamonhangaba, SP, Brazil Efeito de células-tronco mesenquimais na regeneração das estruturas associadas à articulação Bauru School of Dentistry, Bauru, – [email protected] SP, Brazil – [email protected] https://orcid.org/0000-0003-3221-6124 temporomandibular: revisão narrativa https://orcid.org/0000-0003-0413-4658 http://lattes.cnpq.br/4644641106395490 http://lattes.cnpq.br/3826401854753554 Caren Serra Bavaresco, Thiago Kreutz Grossmann, Daniela Seitenfus Rehm, Eduardo Grossmann Telma Regina Mariotto Zakka Rafael Krasic Alaiti University of Sao Paulo, Sao Paulo, University of Sao Paulo, Sao Paulo, SP, Brazil – [email protected] SP, Brazil – [email protected] Financial stress and pain, what follows an economic crisis? Integrative review_____ 280 https://orcid.org/0000-0002-3222-2244 https://orcid.org/0000-0003-1830-7011 http://lattes.cnpq.br/7210747586447129 Estresse financeiro e dor, o que surge após uma crise econômica? Revisão integrativa http://lattes.cnpq.br/2213351462207411 Renato Leonardo de Freitas CORPO EDITORIAL Maurício Kosminsky, Michele Gomes do Nascimento, Gabriela Neves Silva de Oliveira University of Sao Paulo, Ribeirao Preto, Abrahão Fontes Baptista SP, Brazil – [email protected] Federal University of Pernambuco, https://orcid.org/0000-0003-1799-5326 Recife, PE, Brazil – CASES REPORTS http://lattes.cnpq.br/4321982079895528 [email protected] Rosana Maria Tristão Photobiomodulation as an adjuvant in the pharmacological treatment of trigeminal https://orcid.org/0000-0001-7870-3820 Federal University of Brasilia, Brasilia, neuralgia. Case report______285 http://lattes.cnpq.br/3079253830583385 DF, Brasil – [email protected] Angela Maria Sousa https://orcid.org/0000-0002-1751-8506 Fotobiomodulação como adjuvante no tratamento farmacológico da neuralgia trigeminal. Relato University of Sao Paulo, Sao Paulo, SP http://lattes.cnpq.br/4268612281620305 – Brazil – [email protected] Rui Nei de Araújo Santana Jr  de caso https://orcid.org/0000-0003-1732-9083 Bahiana School of Medicine and http://lattes.cnpq.br/9970857881355001 Public Health, Salvador, BA, Brazil João Paulo Colesanti Tanganeli, Denise Sabbagh Haddad, Sandra Kalil Bussadori Claudia Carneiro de Araújo Palmeira – [email protected] Brazilian Institute of Cancer https://orcid.org/0000-0002-4291-3559 Control, Sao Paulo, SP, Brazil – http://lattes.cnpq.br/7169808569004429 Pain management in patients with knee osteoarthritis by ultrasound-guided genicular [email protected] Vania Maria de Araújo Giaretta  nerve block. Case reports______288 https://orcid.org/0000-0002-3508-1512 University of Taubate, Taubate, SP, http://lattes.cnpq.br/5570233456997863 Brazil – [email protected] Manejo de dor em pacientes com osteoartrite de joelho por bloqueio dos nervos geniculares guiado Durval Campos Kraychete https://orcid.org/0000-0003-4231-5054 Federal University of Bahia, Salvador, http://lattes.cnpq.br/4171286622427592 por ultrassonografia. Relato de casos BA – Brazil – [email protected] Walter Lisboa Oliveira  Thiago Alves Rodrigues, Eduardo José Silva Gomes de Oliveira, João Batista Santos Garcia https://orcid.org/000-0001-6561-6584 Federal University of Sergipe, Aracaju, SE, http://lattes.cnpq.br/6008595426904260 Brazil – [email protected] Guilherme Antônio Moreira de Barros https://orcid.org/0000-0001-5798-6737 LETTERS TO THE EDITOR Botucatu Medical School, http://lattes.cnpq.br/0512185167681269 Botucatu, SP, Brazil – What about patients with pain during and after the COVID-19 pandemic?______292 [email protected] INTERNATIONAL BOARD https://orcid.org/0000-0001-6421-353X Allen Finley O que falar sobre pacientes com dor durante e após a pandemia por COVID-19? http://lattes.cnpq.br/4793749773394626 Dalhousie University, Halifax – Canada. Josimari Melo DeSantana Hazem Adel Ashmawi https://orcid.org/0000-0003-4579-7749 University of Sao Paulo, Sao Paulo, SP, Antoon De Laat Brazil – [email protected] Catholic University of Leuven – Belgium. Considerations about the new concept of pain______294 https://orcid.org/0000-0003-0957-971X https://orcid.org/0000-0003-3558-1418 http://lattes.cnpq.br/0885913183990095 Gary M. Heir Considerações sobre o novo conceito de dor Ismar Lima Cavalcanti Medicine and Dentistry University Federal University Fluminense, Niteroi, of New Jersey, New Jersey – EUA. Juliana Barcellos de Souza, Carlos Marcelo de Barros RJ, Brazil – [email protected] https://orcid.org/0000-0001-9571-402X https://orcid.org/0000-0002-0412-2609 Jeftrey P. Okeson http://lattes.cnpq.br/3897507589015450 Kentucky University, Lexington – EUA. INSTRUÇÕES AOS AUTORES______295 Jamir João Sarda Junior https://orcid.org/0000-0002-8303-6150 Instructions to Authors University of Vale do Itajai, Itajai, SC, Jose Manoel Castro Lopes Brazil – [email protected] University of Porto, Porto – Portugal. https://orcid.org/0000-0001-9580-8288 https://orcid.org/0000-0002-6583-1150 http://lattes.cnpq.br/6152374334604475 Mark Jensen João Batista Santos Garcia Washington University, Washington – USA. Federal University of Maranhao, Sao https://orcid.org/0000-0001-9228-8838 Luiz, MA, Brazil – [email protected] Ricardo Plancarte Sanchez https://orcid.org/0000-0002-3597-6471 National Institute of Cancerology, http://lattes.cnpq.br/0424234103760462 México – México José Aparecido da Silva https://orcid.org/0000-0002-7418-1807 University of Sao Paulo, Ribeirao Preto, SP, Brazil – [email protected] EDITORIAL COORDINATION Submitted to articles online: https://orcid.org/0000-0002-1852-369X Evanilde Bronholi de Andrade http://lattes.cnpq.br/7126562427966797 [email protected] https://www.gnpapers.com.br/brjp/default.asp 100

BrJP. São Paulo, 2020 jul-sep;3(3):197-8 EDITORIAL

Revised definition of pain after four decades Definição de dor revisada após quatro décadas

DOI 10.5935/2595-0118.20200191

The revision of the International Association for the Study of Pain defines pain as “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage’’1. Dated from 1979, the first definition recommended by the Subcommittee on Taxonomy and adopted by the IASP Council conceptualized pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage’’. This definition was widely accepted by health professionals and researchers of the field and adopted by several professional organizations, governmental or not, including the World Health Organization (WHO). Over the course of 41 years, the comprehension of the pain phenomenon went through revolutionary changes, including very important publications on its definition and classification, specially in the last decade. In the past, a dichotomous view considered pain only as nociceptive or neuropathic, which excluded other conditions, such as fibromyalgia. In 2016 a third descriptor appeared, nociplastic pain, improving the classification of other painful conditions2. In 2019 another issue of concept and classification was resolved when chronic pain was included in the International Classification of Diseases (ICD)3. This demand resulted from the joint action of IASP and WHO Task Forces. Currently, pain is included in the ICD-11 with 7 sub-categories, 1 primary and 6 secondary. Recently, some professionals and researchers of the field of pain argued that the progress in the understanding of pain justified a ree- valuation of the definition, presenting proposals of modification, strong opinions in favor or opposing to the need for a revision and, therefore, discussing modifications through the last few years4,5. Due to the continuous and consistent advances in knowledge about pain and its mechanisms, pain terminology must also be modified and adjusted. Therefore, in 2018, IASP called for a multinational Presidential Task Force composed of 14 professionals with extensive experience in pain-related clinical and/or basic science to evaluate the current definition and its explanatory notes and recommend whether such a definition should be maintained or changed. The revision offers summary of the critical concepts, commentary analysis of the IASP members and the public, as well as the final recommendations of the committee on the definition revision and the notes that were discussed for two years. Finally, the Task Force recommended a revised definition of pain in the beginning of 2020. The board of the Sociedade Brasileira para o Estudo da Dor (SBED - Brazilian Society for the Study of Pain) published not only the official translation into Portuguese of the revised definition and its notes, but also the entire article, considering the semantic and lin- guistic aspects for the Portuguese language and Brazilian context6,7. The necessary steps for the official translation of this definition of pain and its complementary notes into Portuguese were carried out, in order to ensure that the Brazilian population had wide access to a uniform discourse in their native idiom. Initially, the article was completely translated by a language professional specialized in Portuguese and English. Next, a review and discussion of the translation was brought forward by members of the board, clinicians and/or researchers on the field of pain with, at least, 15 years of experience. The individual reviews were shared and specifically analyzed in online real time remote meetings, followed by a second phase of review until a consensus was reached. The definition revised in 2020, conceptualizing pain as “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage’’, presented an unambiguous and concise formulation, easily translatable to other languages; comprising the most varied experiences of pain, its diversity and complexity, being valid for acute pain as well as chronic pain; applicable in all conditions of pain, from humans to animals and, most importantly, defined by the perspective of the person who is in pain1,6,7. The definition is complemented by 6 explanatory notes that come to be a list of items that include etymology: 1. Pain is always a personal experience that is influenced, to varying degrees, by biological, psychological and social factors. 2. Pain and nociception are different phenomena. Pain cannot be determined exclusively by the activity of sensitive neurons. 3. through their life experiences, people learn the concept of pain. 4. A person’s account of an experience of pain should be respected. 5 Although pain usually plays an adaptive role, it can have adverse effects on function as well as social and psychological well-being. 6. Verbal description is only one of several behaviors that may express pain; the inability to communicate does not invalidate the possibility of a human or animal to feel pain1,6,7. These explanatory notes complement the definition of pain, recognizing, but not being restricted to, advances in knowledge based on the modern neuroscience of pain, also incorporating other relevant factors such as cognition, behaviors, as well as cultural and educational factors.

197 BrJP. São Paulo, 2020 jul-sep;3(3):197-8 DeSantana JM, Perissinotti DM, Oliveira Junior JO, Correia LM, Oliveira CM and Fonseca PR

At the end of the explanatory notes, etymological information José Oswaldo de Oliveira Junior3 on the origin of the word pain is presented: 1. from Middle En- https://orcid.org/0000-0003-1748-4315 glish, Anglo-French peine (pain, suffering), 2. from Latin poena Luci Mara França Correia4 (sentence, punishment) and 3. From the Greek poin-e (payment, https://orcid.org/0000-0002-4977-255X penalty, reward)1,6,7. Célia Maria de Oliveira5 A definition provides comprehension, concept, or common idea https://orcid.org/0000-0002-1937-7364 about a determined word. The definition of the word generates the Paulo Renato Barreiros da Fonseca6 possibility of acknowledgment, value, signification and its objecti- https://orcid.org/0000-0001-8928-4510 ve is to direct a specific discussion on all related subjects and must 1. Diretora Tesoureira da SBED. Fisioterapeuta, Professora Asso- only be rejected in the case of an explicit or implicit logical contra- ciada do Departamento de Fisioterapia da Universidade Federal de diction. This type of definition is supposed to be used for as long Sergipe. Professora dos Programas de Pós-Graduação em Ciências as it serves its work purpose, therefore it is, in essence, temporary. da Saúde e Ciências Fisiológicas, Chefe do Serviço de Dor e Movi- This revised definition of pain is timely and in line with all IASP’s mento. Aracaju, Se, Brasil. E-mail: [email protected] current efforts to advance ontological structures of pain, and this 2. Diretora Administrativa da SBED, Psicóloga, Doutora em editorial does not intent to interpret or judge this revision. All of Ciências pelo Departamento de Neurologia da Universidade de the facts that occurred in the process executed by the Task Force São Paulo, Pós-Doutora pelo Departamento de Psiquiatria da were exposed in the IASP publication, as well as the narration of Escola Paulista de Medicina da Universidade Federal de São Pau- the reiterated discussions and interpretations made by the mem- lo. São Paulo, SP, Brasil. E-mail: [email protected] bers and their consultants. 3. Vice-Presidente da SBED, Neurocirurgião, Professor Dou- Instead, the IASP’s initiative should be valued by understanding tor da Disciplina de Dor Oncológica da Escola de Oncologia the changes in the scenario of pain and welcoming the eagerness of da Fundação Antonio Prudente, Responsável pela Neurocirurgia the scientific and professional community for the need of reevalua- Funcional e Grupo Especializado em Dor do Serviço de Neuro- tion, as well as the effort and dedication of the Task Force mem- cirurgia do Hospital Servidor Público Estadual. São Paulo, SP, bers in developing a process for reviewing the definition of pain ac- Brasil. E-mail: [email protected] cording to epistemological, ontological and practical dimensions, 4. Diretora Científica da SBED. Odontóloga. Professora de whose steps were conducted in a socially responsible, democratic, Pós-Graduação em Dor na área de Dor Orofacial. Membro da participatory, transparent and scientific method-based manner. Equipe Interdisciplinar de Cefaleia e Dor Orofacial do Instituto A uniform and widely known terminology in the field of pain de Neurologia de Curitiba. Curitiba, PR, Brasil. E-mail: draluci. that communicates information about patients and their pain [email protected] is important to determine basic terms of pain and the classifica- 5. Diretora Secretária da SBED, Enfermeira, Professora Adjunta tion of their syndromes and clinical conditions, which has been do Departamento de Enfermagem Básica da Escola de Enferma- the constant focus of several IASP committees. Thus, the pro- gem da Universidade Federal de Minas Gerais. Belo Horizonte, posed definition creates a common understanding of the term MG, Brasil. E-mail: [email protected] “pain’’ for health professionals, researchers and people with pain 6. Presidente da SBED. Anestesiologista, Professor Coordenador all around the globe, also providing a base for researches in the da Pós-Graduação em Dor - Ensino Einstein. Rio de Janeiro, RJ, field, with the objective of minimizing epistemological mistakes, Brasil. E-mail: [email protected] and influencing public health politics, which tend to provide improvement in health care. As the Task Force itself recommended, REFERENCES this revised definition of pain published through a narrative re- 1. Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, et al. The revised In- view is a living document to be updated in line with the future ternational Association for the Study of Pain definition of pain: concepts, challenges, progress of the field. and compromises. Pain. 2020;23. doi: 10.1097/j.pain.0000000000001939. Online ahead of print. 2. Kosek E, Cohen M, Baron R, Gebhart GF, Mico JA, Rice ASC, Rief W, Slu- Yours sincerely, ka KA. Do we need a third mechanistic descriptor for chronic pain states? Pain. 2016;157(7):1382-6. 3. Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, et al. A classification of Diretoria da Sociedade Brasileira para o Estudo chronic pain for ICD-11. Pain. 2015;156(6):1003-7. da Dor (SBED) - Gestão 2020-2021 4. Williams ACC, Craig KD. Updating the definition of pain. Pain. 2016;157(11):2420-3. 1 5. Cohen M, Quintner J, van Rysewyk S. Reconsidering the International Association Josimari Melo DeSantana for the Study of Pain definition of pain. Pain Rep. 20185;3(2):e634. https://orcid.org/0000-0003-1432-0737 6. https://sbed.org.br/wp-content/uploads/2020/08/Defini%C3%A7%C3%A3o-revi- 2 sada-de-dor_3.pdf Dirce Maria Navas Perissinotti 7. Jornal Dor (Publicação da Sociedade Brasileira para o Estudo da Dor – Ano XVIII – https://orcid.org/0000-0002-0346-1190 2º Trimestre de 2020 – edição 74, 11-8.

198 BrJP. São Paulo, 2020 jul-sep;3(3):199-204 ORIGINAL ARTICLE

Evaluation of the keratinocytes or fibroblasts culture supernatant in an inflammatory hyperalgesia model Avaliação do sobrenadante da cultura de queratinócitos ou fibroblastos em modelo de hiperalgesia inflamatória

Cíntia Ávila Souza1,2, Gilson Gonçalves dos Santos1, Felipe Hertzing Farias1, Eli Ávila Souza Júnior3, Carlos Amilcar Parada1

DOI 10.5935/2595-0118.20200038

ABSTRACT endogenous opioids. In addition, it has been observed that the analgesic effect of the fibroblast culture supernatant is mediated BACKGROUND AND OBJECTIVES: Inflammation is a de- specifically by the µ opioid agonist, having a duration of 2 hours. fense response of the body to a cellular damage caused by phy- Keywords: Analgesia, Fibroblasts, Keratinocytes, Peripheral ner- sical, chemical or biological agents, which triggers, among other vous system, Skin. factors, pain. Although inflammation plays an important role in the protection and regeneration of tissue injury, inflamma- RESUMO tory pain results in decreased quality of life. In view of this, the development of safe and less invasive forms for the treatment of JUSTIFICATIVA E OBJETIVOS: A inflamação é uma resposta inflammatory pain is of great importance. The objective of this de defesa do organismo a uma lesão celular causada por agentes study was to evaluate the antihyperalgesic potential of the culture físicos, químicos ou biológicos, a qual desencadeia, entre outros supernatant of keratinocytes and human fibroblasts in an experi- fatores, a dor. Apesar da inflamação possuir um importante papel mental model of inflammatory hyperalgesia. na proteção e regeneração da lesão tecidual, a dor inflamatória METHODS: Evaluation of carrageenan induced inflammatory culmina na diminuição da qualidade de vida. Diante disso, é de hyperalgesia through the use of electronic von Frey in animal grande importância o desenvolvimento de formas seguras e me- models treated with culture supernatant of keratinocytes and finos invasivas para o tratamento da dor inflamatória. O objetivo broblasts. deste estudo foi avaliar o potencial anti-hiperalgésico do sobre- RESULTS: Local administration of naloxone, a nonselective nadante de cultura de queratinócitos e fibroblastos humanos em opioid antagonist, in peripheral tissue, has been observed to modelo experimental de hiperalgesia inflamatória. inhibit the antihyperalgesic effect of the keratinocyte culture MÉTODOS: Avaliação da hiperalgesia inflamatória induzida supernatant. Fibroblast culture supernatant on days 1 and 3 repor carragenina, através do uso de von Frey eletrônico, em mo- verses for 2 hours the carrageenan induced inflammatory hype- delos animais tratados com sobrenadante de cultura de querati- ralgesia, which is mediated by µ opioid agonist. nócitos e fibroblastos. CONCLUSION: This study indicates that culture supernatant RESULTADOS: Observou-se que a administração local de na- of fibroblasts and keratinocytes is capable of inducing antinoci- loxona, antagonista opioide não seletivo, em tecido periférico ception in inflammatory hyperalgesia, mediated by the release of inibiu o efeito anti-hiperalgésico do sobrenadante da cultura de queratinócitos. Sobrenadante de cultura de fibroblastos dos dias 1 e 3 reverte por 2h a hiperalgesia inflamatória induzida por carragenina, sendo esta mediada por agonista µ opioide.

Cíntia Ávila Souza – https://orcid.org/0000-0001-8116-010X; CONCLUSÃO: Este estudo indicou que sobrenadante de cultu- Gilson Gonçalves dos Santos – https://orcid.org/0000-0002-2704-3006; ra de fibroblastos e queratinócitos foi capaz de induzir antinoci- Felipe Hertzing Farias – https://orcid.org/0000-0002-0521-9664; cepção em hiperalgesia inflamatória, mediada pela liberação de Eli Ávila Souza Júnior – https://orcid.org/0000-0002-5054-874X; Carlos Amilcar Parada – https://orcid.org/0000-0001-5209-8853. opioides endógenos. Além disso, observou-se que o efeito anal- gésico do sobrenadante de cultura de fibroblastos é mediado es- 1. Universidade Estadual de Campinas, Instituto de Biologia, Laboratório de Estudo da Dor, Campinas, SP, Brasil. pecificamente por agonista µ opioide, tendo uma duração de 2h. 2. Universidade Estadual de Campinas, Faculdade de Ciências Médicas, Graduação em Me- Descritores: Analgesia, Fibroblastos, Pele, Queratinócitos, Siste- dicina, Campinas, SP, Brasil. 3. Universidade Federal de Alfenas, Faculdade de Medicina, Alfenas, MG, Brasil. ma nervoso periférico.

Submitted on February 20, 2020. INTRODUCTION Approved for publication on May 10, 2020. Conflict of interests: none – Sponsoring sources: CNPq under number 138343/2017-9. Inflammation is a defense response to cellular damage caused by Correspondence to: 1 Rua Jasmin, 190 – Chácara Primavera physical, chemical or biological agents . Inflammatory process 13087-460 Campinas, SP, Brasil. is characterized by a series of interrelated events that seek to re- E-mail: [email protected] [email protected] cover tissue integrity, among which are: increased blood flow to © Sociedade Brasileira para o Estudo da Dor the affected region, increased vascular permeability, fluid leaka- 199 BrJP. São Paulo, 2020 jul-sep;3(3):199-204 Souza CA, Santos GG, Farias FH, Souza Júnior EA and Parada CA ge, migration and accumulation of defense cells2. The resulting jor disadvantage to their use26-28. The direct relationship between characteristic signs of this process, the cardinal signs, are: pain, the peripheral nervous system, keratinocytes and fibroblasts is tumor, redness, loss of function and heat1-3. highlighted as a promising fact in the search for different safe Although it’s an important mechanism for warning and pro- forms of analgesia, especially because it’s a local action. Thus, the tection of a possible tissue injury, pain creates suffering, which present study evaluated the antihyperalgesic potential of human leads to a decreased quality of life4. It’s known that perception keratinocyte and fibroblast culture supernatant in an experimen- of pain is triggered by the activation of specialized cells, called tal model of inflammatory hyperalgesia. nociceptors5. The nerve endings that detect this type of stimulus are the Aδ and C fibers. While the Aδ fibers are myelinized, METHODS with rapid transmission of the painful stimulus and therefore responsible for the acute phase of pain, the non-myelinized, 72 male Wistar rats from 6 to 8 weeks of age (200-250g) from slow-conducting C fibers have a greater role in inflammatory the Multidisciplinary Center for Biological Research in the Field and chronic pain6,7. of Laboratory Animal Science – CEMIB were used. The animals During the inflammatory process, algogenic substances are re- were put in appropriate cages containing 4 animals/box, remai- leased, which are able to sensitize the nociceptors, reducing the ning in ventilated shelves with controlled temperature and hu- excitability threshold. Among them, the following can be men- midity 22°C and 55%, respectively, with a 12h light/dark cycle. tioned: acetylcholine, bradycinine, histamine, serotonin, leuko- The animals received water and feed ad libitum throughout the triene, substance P, among others8. The persistence of inflamma- research. The animals were randomly divided into groups. After tion leads to changes in the peripheral nervous system, where the study, the animals were anesthetized and then euthanized by there will be an exacerbation of the response to painful stimuli, decapitation. The size of group (n) for each experimental group known as hyperalgesia9. is presented below: Furthermore, endogenous mechanisms that counterbalance the changes caused by inflammation triggered by the initial lesion Processing of biological material (skin) are released in order to regulate it. A characteristic example is the The fragments of human skin from blepharoplasties of healthy release of endogenous opioids and peptides derived from protein individuals performed by the team of Ophthalmologic Plastics precursors synthesized by synovial cells, mast cells, lymphocytes, of the University Hospital were sent to the Skin Cell Culture neutrophils, monocytes and skin cells, such as keratinocytes and Laboratory under protocol number 16013-2/2016 and proces- fibroblasts that migrated to the lesion sites9-12. Another exam- sed in a sterile area, clean room ISO 7 class, the fat tissue was ple is the increased expression of receptors in peripheral sensory discarded. The fragments were placed on a Petri dish and divided neurons and the rupture of the perineural barrier, facilitating the into two portions, one of which was frozen in a -80ºC freezer. interaction of opioids and their receptors13. The other portion was sectioned into 2 to 3 mm fragments using There are three families of endogenous opioids described in a surgical instrument under laminar flow in order to keep the en- the literature: endorphins (derived from proopiomelanocor- tire procedure sterile. The smaller skin fragments were submitted tin - POMC), enkephalins (derived from proenkephalin - to enzymatic treatment with 10 mL of 0.25% trypsin solution PENK) and dynorphins (derived from prodynorphin)14. Each and 1 mM of ethylenediaminetetraacetic acid (with the epider- one presents specificity with different opioid receptors: μ (en- mis always facing up) and incubated at 37°C with a 5% tension δ dorphin and enkephalin), (enkephalin and endorphin) and of CO2 for four hours, resulting in separation of the epidermis κ (dynorphin)12,15. from the dermis. Production of endogenous opioids is known to be performed by cells of the immune system11,16. However, studies demons- Isolation and culture of fibroblasts trate their production also in keratinocytes and fibroblasts17-22. After incubation of the fragments, trypsin was inactivated with Authors have observed that fibroblasts and keratinocytes express the same volume of culture medium and the dermis fragments functional proenkephalin messenger (PENK) RNA, being able were placed in a culture vial with M199 fibroblast medium su- to synthesize and secrete PENK-derived peptides, such as enke- pplemented with L-glutamine 2mM, penicillin 100UI/mL, phalins21. The release of inflammatory factors, especially inter- streptomycin 0.1mg/mL and 10% bovine fetal serum (BFS). The leukin 1β (IL-1β), induces the expression and release of endoge- cells were nourished by changing the culture medium every three nous opioids, which, once attached to the receptors of peripheral days. When these cells obtained a 90% confluence, approxima- nerve fibers, trigger an increase in potassium currents and a de- tely 7 days after the culture started, the cellular replication was crease in calcium currents in the bodies of sensory neurons, inhi- performed with the help of a 0.25% trypsin solution and 1mM biting neuronal triggering and transmitter release23,24. ethylenediaminetetraacetic acid. The cells were used between Considering that inflammatory hyperalgesia triggers negative 2-3th passages. At the time, the obtained fibroblasts were washed emotional and physical responses compromising quality of life3, three times with Hank’s solution. the development of safe forms of treatment is very important. Exogenous opioids are still the most used options in the treat- Isolation and culture of keratinocytes ment of different algetic stimuli25. However, important side ef- After the epidermis was separated, trypsin was neutralized using fects associated with these pharmacological options remain a ma- the same volume of specific culture medium for keratinocytes. 200 Evaluation of the keratinocytes or fibroblasts culture BrJP. São Paulo, 2020 jul-sep;3(3):199-204 supernatant in an inflammatory hyperalgesia model

The cell suspension obtained was filtered through a 40µm nylon clear phase, between 9:00 a.m. and 5:00 p.m., in a quiet room, with filter and centrifuged at 1200rpm and 4°C for 10 minutes. The room temperature maintained at 23ºC. cell pool obtained, consisting of keratinocytes and melanocytes, was counted and plated in culture flasks, with 1x105 cells per Evaluation of the hyperalgesic effect of the keratinocyte cul- 2 cm , incubated at 37°C, with 5% tension of CO2, in keratino- ture supernatant cyte specific culture medium, complemented with L-glutamine In a first phase, carrageenan (100μg/50uL/paw) was administe- 2mM/mL, penicillin 100UI/mL and streptomycin 0.1mg/mL. red via i.p.l., which induced inflammatory hyperalgesia for the The primary keratinocytes culture was obtained from the adhe- 6 hours of evaluation. After two hours of administration of the sion of the cells to the culture flasks which occurred in approxi- hyperalgesic agent, a non-selective opioid antagonist (naloxone) mately 48h. The cells were nourished by changing the culture was administered at the same site. After 2h30min, 50μL of ke- medium every three days. The cellular replication was performed ratinocyte culture supernatant (treated groups, n=6) of 3 days or in approximately 7 days when the cells reached 90% of confluen- 50μL of keratinocyte culture medium (control group, n=6) were ce and were used in the second passage. administered at the same site. After 30 minutes of administration of the supernatant, mechanical hyperalgesia was evaluated Drugs using the von Frey test (Results item 1). Carrageenan at 100µg/50µL/paw (Sigma) was used for induc- tion of inflammatory hyperalgesia. Administration of carragee- Evaluation of the time-response curve of the different days (1 nan (100µg/50uL) in the subcutaneous tissue of the rear leg in- or 3 days) of keratinocytes or fibroblasts supernatant culture duces inflammatory hyperalgesia for 6 hours, whose pain peak against inflammatory yperalgesia occurs in the third hour31. The electronic test of mechanical hyperalgesia (von Frey) was per- The selective opioid receptors antagonists used were: CTOP formed prior to the study. After 1h, carrageenan (100μg/50μL/ (Sigma Aldrich/ P5296, subunit µ antagonist), Nor- BNI (Nor- paw) was administered via i.p.l. of the right posterior paw. After binaltorphimine/Sigma Aldrich; subunit kappa antagonist) and 2h of the administration of the hyperalgesic agent, in the same N115 (Naltrindole/ HCL – Sigma Aldrich; subunit delta anta- place, 50μL of supernatant of the keratinocyte culture (treated gonist). The non-selective opioid receptor antagonist used was groups, n=6) of different days (1 and 3 days) or 50µL of culture naloxone (nalo, Sigma yperal). medium for keratinocytes (control group, n=6) was administered in the periods already described. To establish the time-response Intraplantar injection of drugs curve, after 0.5, 1, 2, 4 and 6 hours of administration of the su- The administration of drugs through the intraplantar route pernatant, mechanical hyperalgesia was evaluated using the von (i.p.l.) was performed using a hypodermic BD Ultra-Fine® needle Frey test (Results item 2). (29G) which was inserted after antisepsis into the subcutaneous tissue of the plantar surface of the right posterior limb. Participation of opioid receptors and their subunits in the antihyperalgesic effect of the supernatant from keratinocyte Behavioral test (von Frey electronic test) culture against inflammatory yperalgesia The evaluation of mechanical hyperalgesia in the paw of rats was The electronic test of mechanical hyperalgesia (von Frey) was per- performed through electronic von Frey in basal conditions and formed prior to the study. After 1h, carrageenan (100μg/50μL/ after the stimulus in the paw. In this method the electronic anes- paw) was administered via i.p.l. of the right posterior paw. After thesiometer was used, consisting of a pressure transducer con- 2h of the administration of the hyperalgesic agent, selective an- nected to a cable and to a digital force detector in which the force tagonists from the mμ (CTOP, 20μg/50μL/paw), kappa (Nor- exerted was expressed in grams. At the end of the transducer -BNI, 10μg/50 20μg/paw) and delta (N115, 3μg/50μL/paw) there is a tip through which a force in a straight angle was applied opioid sub-units were administered via the intraplantar route in the central region of the animal’s rear leg with gradually in- of the right posterior paw. After 2.5 hours of carrageenan ad- creasing pressure. The stimulus was interrupted after the feature ministration, the supernatant of the keratinocyte culture (trea- observation of paw removal (flinches). ted group) was administered (n=6/group). After 30 minutes of For the experiment, 6 acrylic boxes measuring 12x20x17cm were administration of the supernatant, mechanical hyperalgesia was used, the flooring was composed of an iron mesh net, in which there evaluated using the von Frey test (Results item 3). was, 25cm below the experimental boxes, an inclined mirror used The experiments followed the guidelines of the Ethics Commit- for visualization of the lower part of the paw, facilitating the appli- tee for Animal Research of the University, under protocol num- cation of the tip. Before the experiment, the animals were kept for ber 4654-1/2017, and the standards established by the Interna- 15 minutes inside the boxes for adaptation. Three measurements tional Association for the Study of Pain (IASP). per animal were performed, the final value was the average of the measurements. The intensity of mechanical hypernociception was Statistical analysis measured as the D reaction pressure variation in grams, obtained The results were expressed as mean±standard mean error (s.m.e.). by subtracting the value observed before the experimental proce- The data analysis was performed by the ANOVA One-way or dure (basal) from the reaction value after the administration of the Two-way Variance analysis test, followed by the Bonferroni test inflammatory stimulus. The test sessions were performed during the for multiple comparisons. The significance level was from p<0.05. 201 BrJP. São Paulo, 2020 jul-sep;3(3):199-204 Souza CA, Santos GG, Farias FH, Souza Júnior EA and Parada CA

RESULTS Comparing the time-response curve of BF1 and BF3 for 12h, there is no difference in time and duration of hyperalgesia reduc- 1. Local administration of naloxone to the peripheral tissue tion (Cg. + BF1 and Cg. + BF3) between 1 or 3 day supernatant inhibits the antihyperalgesic effect of the supernatant from of isolated culture of fibroblasts. keratinocyte culture The administration of carrageenan (100μg/50μL/paw) i.p.l. in- Cg. duced inflammatory hyperalgesia for the 6 hours of evaluation. Cg. + FB1 After two hours of administration of the hyperalgesic agent, a Cg. + FB3 non-selective opioid antagonist (naloxone) was administered at the same site. After 2.50 hours, 50μL of keratinocyte culture su- 30 pernatant (treated groups, n=6) of 3 days or 50μL of keratinocyte culture medium (C.M., 50μL) (control group, n=6) were 20 administered at the same site. 10 As shown in figure 1, supernatant of keratinocyte culture (C.M., 50μL) reversed carrageenan induced mechanical hyperalgesia. 0

The analgesic effect of C.M. was reversed by local pre-treatment threshold) ( ∆ removal

Intensity of hyperalgesia -10 with naloxone (Nalo, 10μg), a non-selective opioid receptor antagonist. Administration of C.M. (50μL) in the contralateral 0 0,5 1 2 4 6 12 paw did not alter the hyperalgesic threshold of the carrageenan, Time after supernatant treatment (hours) showing that the effect of C.M. has a local and non-systemic effect. Administration of pure culture medium (P.M.) does not Figure 2. Local administration of fibroblast culture supernatant in peripheral tissue temporarily reduces carrageenan induced mechanical alter the hyperalgesic threshold of carrageenan. hyperalgesia Cg = carrageenan; FB1 = 1-day fibroblast culture supernatant; FB3 = 3-day fibroblast culture supernatant. 30 3. The antihyperalgesic effect of the supernatant from the fi- 20 broblast culture is mediated by the μ opioid receptor Since the analgesic effect of the supernatant from the fibroblast culture is measured by opioid receptors, which opioid receptor is 10 specifically involved in this analgesic effect was analyzed. Selective antagonists from the μ opioid (CTOP, 20µg/50µL), kappa (Nor- -BNI, 10µg/50µL) and delta (N115, 3µg/50µL) sub-units were 0 removal threshold) ( ∆ removal NaCl Nalo. M.P administered through an intraplantar way 30 minutes before the Intensity of hyperalgesia 10% 10uL 50 ug administration of the fibroblast culture supernatant. As shown in -10 M.C 50 uL Figure 3, carrageenan induced hyperalgesia, which was reversed

Cg. 100 ug 40 Figure 1. 3-day keratinocyte culture medium reverses carrageenan induced mechanical hyperalgesia 3-day keratinocyte culture supernatant. C.M = medium for keratinocyte culture; 30 P.M. = pure medium for keratinocyte culture; NaCl = 0.9% sodium chloride; Nalo = naloxone; Cg = carrageenan.

2. Supernatant day 1 and 3 fibroblast culture temporarily re- 20 verses carrageenan induced inflammatory hiperalgesia Since the culture of keratinocytes for clinical use has a 3:1 ratio

removal threshold) ( ∆ removal 10

(keratinocytes: fibroblast), the possibility of the culture alone ha- Intensity of hyperalgesia ving the same analgesic effect was analyzed. The supernatant of isolated fibroblast culture (FB1 and FB3, 50µL) on days 1 and 3 0 reversed carrageenan induced hyperalgesia (Cg.) at a time of 0.5 Cg and 1h, as shown in figure 2. However, this effect was temporary, Cg + FB1 with a resumption of hyperalgesia after 2h. The administration Cg + CTOP + FB1 Cg + N115 + FB1 of FB1 and FB3 (50μL) in the contralateral paw did not change Cg + nor-BNI + FB1 the hyperalgesic threshold of carrageenan, showing that the ef- Figure 3. Opioid µ subunit antagonist inhibits the supernatant analge- fect of FB1 and FB2 is local and non-systemic. Administration sic effect of fibroblast culture Cg = carrageenan; FB1 = 1-day fibroblast culture supernatant; CTOP = µ su- of pure culture medium (M199) does not change the hyperalge- bunit antagonist; Nor-BNI = kappa subunit antagonist; N115 = delta subunit sic threshold of carrageenan. antagonist. 202 Evaluation of the keratinocytes or fibroblasts culture BrJP. São Paulo, 2020 jul-sep;3(3):199-204 supernatant in an inflammatory hyperalgesia model by FB1 (Two-way ANOVA, Bonferroni test, ***p<0.001). CTOP, ved. Such correlation is a potential and safe target for the deve- but not Nor-BNI or N115, inhibited the antihyperalgesic effect of lopment of new antinociceptive methods that seek the reduction fibroblast culture supernatant on carrageenan induced hyperalge- of known adverse effects with the wide use of exogenous opioids. sia (Two-way ANOVA, Bonferroni test, p>0.05). CONCLUSION DISCUSSION The present study indicated that fibroblasts and keratinocytes su- Studies have shown that besides being synthesized by immune cells, pernatant culture was able to induce antinociception in carragee- other cells such as keratinocytes and fibroblasts also play an important nan induced inflammatory hyperalgesia, which is mediated by role in endogenous peripheral antinociception, since such cells express the release of endogenous opioids. In addition, it was observed functional PENK mRNA, being able to synthesize and secrete PENK- that the reduction of hyperalgesia by fibroblast culture superna- -derived peptides such as enkephalins. The release of inflammatory fac- tant is specifically mediated by the μ opioid agonist. tors, notably IL-1β, induces the expression and release of opioids by these cells, which, once attached to the receptors of peripheral nerve REFERENCES fibers, inhibit neuronal triggering and transmitter release12-16. 1. 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27. Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The effecti- 1991;45(2):211- 6. veness and risks of long-term opioid therapy for chronic pain: a systematic review for 31. Henriques MG, Silva PM, Martins MA, Flores CA, Cunha FQ, Assreuy-Filho a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. J, et al. Mouse paw edema. A new model for inflammation? Braz J Med Biol Res. 2015;162(14):276-86. 1987;20(2):243-9. 28. Eriksen J, Sjogren P, Bruera E, Ekholm O, Rasmussen NK. Critical issues on opioids 32. Bodnar RJ. Endogenous opiates and behavior: 2017. Peptides. 2020;124:170223. in chronic non-cancer pain: an epidemiological study. Pain. 2006;125(1-2):172-9. 33. Leong C, Neumann C, Ramasamy S, Rout B, Wee LY, Bigliardi-Qi M, et al. Inves- 29. Vivancos GG, Verri WA Jr, Cunha TM, Schivo IR, Parada CA, Cunha FQ, et al. tigating endogenous µ-opioid receptors in human keratinocytes as pharmacological An electronic pressure-meter nociception paw test for rats. Braz J Med Biol Res. targets using novel fluorescent ligand. PloS one. 2017;12(12):e0188607. 2004;37(3):391-9. 34. Li X, Zhu J, Tao Y, Tao K. Elevated endogenous opioids in obstructive jaundice: the 30. Rosland JH. The formalin test in mice: the influence of ambient temperature. Pain. possible skin mechanisms. Med Hypotheses. 2018;116:119-21.

204 BrJP. São Paulo, 2020 jul-sep;3(3):205-12 ORIGINAL ARTICLE

Effects of neural mobilization on individuals with chronic low back pain Efeito da mobilização neural em indivíduos com dor lombar crônica

Marina Ramos1, Caio A. H. Cruz2, Moises F. Laurentino2, Hazem Adel Ashmawi3, Fabio M. Santos2, Marucia Chacur1

DOI 10.5935/2595-0118.20200041

ABSTRACT CONCLUSION: The technique was able to reduce pain intensity and consequently increase the mobility of the volunteers. BACKGROUND AND OBJECTIVES: The objective of this Additionally, a difference in cytokine concentration at the end of study was to evaluate the effect of neural mobilization technique the treatment and an improvement in the individuals quality of on individuals with chronic low back pain, as well as analyze life were observed. possible changes in pain, motor behavior and on cytokine quan- Keywords: Low back pain, Pain, Quality of life. tification before and after treatment. METHODS: Sixteen individuals with mean age of 30.45±10.32 RESUMO years old were evaluated. The technique consisted of a total of 10 interventions, with a total duration of 10 minutes, divided into JUSTIFICATIVA E OBJETIVOS: O objetivo deste estudo foi four series of 2 minutes each, with a 30-second interval between avaliar o efeito da técnica de mobilização neural em indivíduos each series. The following outcomes were evaluated: pain inten- com lombalgia crônica, assim como possíveis alterações na dor, sity using the visual analog scale; mobility of the lumbar spine no comportamento motor e na quantificação de citocinas antes with the third finger to the ground test and hip goniometry; e após o tratamento. concentration of cytokines in serum with the multiplex techni- MÉTODOS: Foram avaliados 16 indivíduos com idade média de que; and quality of life with the Oswestry Disability Index, the 30,45±10,32 anos. A técnica consistiu em um total de 10 interven- Roland-Morris Disability Questionnaire and the World Health ções, com duração total de 10 minutos, divididas em quatro séries Organization Quality of Life Questionnaire-bref. de 2 minutos cada, com intervalo de 30 segundos entre cada série. RESULTS: Results showed a reduction in pain intensity of Os desfechos a seguir foram avaliados: intensidade da dor utilizan- approximately 70% between the assessments (p<0.001). Im- do a escala analógica visual; mobilidade da coluna lombar com o provements in lumbar mobility of approximately 25.5% on the terceiro dedo até o solo e goniometria do quadril; concentração de third finger to the ground test (p<0.04) and improvement in citocinas no soro com a técnica multiplex; e qualidade de vida com the hip joint angles (p<0.04) were also observed. A difference o Oswestry Disability Index, o Roland-Morris Disability Questionnaire in cytokine concentrations, both pro-inflammatory (p<0.009) e o World Health Organization Quality of Life Questionnaire-bref. and anti-inflammatory (p<0.03), was also observed between RESULTADOS: Os presentes resultados demonstraram uma the assessments. redução na intensidade da dor de aproximadamente 70% entre as avaliações (p<0,001). Foram observadas melhoras na mobilidade lombar de aproximadamente 25,5% no terceiro dedo para o teste do solo (p<0,04) e nos ângulos da articulação do quadril (p<0,04). Também foi observada entre as avaliações diferença nas Marina Ramos – https://orcid.org/0000-0001-9729-2799; concentrações de citocinas, tanto pró-inflamatórias (p<0,009) Caio A. H. Cruz – https://orcid.org/0000-0001-9927-2724; Moises F. Laurentino – https://orcid.org/0000-0001-7986-2452; quanto anti-inflamatórias (p<0,03). Hazem Adel Ashmawi – https://orcid.org/0000-0003-0957-971X; CONCLUSÃO: A técnica foi capaz de reduzir a intensidade da Fabio M. Santos – https://orcid.org/0000-0002-0415-1960; dor e consequentemente aumentar a mobilidade dos voluntários. Marucia Chacur – https://orcid.org/0000-0002-0172-4110. Além disso, foi observada uma diferença na concentração de ci- 1. Universidade de São Paulo, Departamento de Anatomia, Instituto de Ciências Biomédi- tocinas no final do tratamento e uma melhoria na qualidade de cas, São Paulo, SP, Brasil. 2. Universidade Nove de Julho, Departamento de Ciências Médicas, São Paulo, SP, Brasil. vida dos indivíduos. 3. Universidade de São Paulo, Faculdade de Medicina, Serviço de Dor, São Paulo, SP, Brasil. Descritores: Dor, Dor lombar, Qualidade de vida.

Submitted on February 18, 2020. Accepted for publication on May 25, 2020 INTRODUCTION Conflict of interests: none – Sponsoring sources: FAPESP 2017/05218-5

Correspondence to: The term low back pain is characterized mainly by pain in the USP - Instituto de Ciências Biomédicas III lumbar spine region, a condition that affects individuals of both Departamento de Anatomia Av. Prof. Lineu Prestes, 2415; sala: 007 sexes and reduces their ability to perform activities in their daily 05508-900 São Paulo, SP, Brasil. lives, which results in a substantial economic cost to society1,2. E-mail: [email protected] Notably, approximately 70% of Brazil’s population may have an © Sociedade Brasileira para o Estudo da Dor episode of low back pain during their lifetime3,4. 205 BrJP. São Paulo, 2020 jul-sep;3(3):205-12 Ramos M, Cruz CA, Laurentino MF, Ashmawi HA, Santos FM and Chacur M

The etiology regarding the development of low back pain is still Individuals excluded were: suffering from acute low back unclear due to the innumerable factors that may lead to its on- pain; spondylolisthesis or fibromyalgia; had previous spinal set, some of which may be related to repetitive work, pulling surgery; any sequelae that caused limitations in the range of and pushing, falls, poor posture, squatting, heavy lifting, muscle motion of the lower limb or joint deformity; metal plates, imbalance, and compressive syndromes, among others. Chronic screws, neurological disorders which determine caution in pain is among the main causes of absenteeism at work, medical regard to NM; cancer; cognitive disturbances or apparent leave, sick leave, workers’ compensation, and low productivity limitations; any type of pain in other regions that is not at work1,5-8. characteristic of low back pain; advanced diabetes mellitus; It’s important to emphasize that limited mobility of the lum- under physiotherapeutic treatment for the same reason; non bar spine due to pain can often be associated with this condi- compensated cardiovascular diseases; significant changes in tion5. Another extremely relevant point regarding spinal ner- sensitivity; edema in the lower limbs; and pregnant women. ve injuries, particularly in the lumbar region, is that they are After eligibility was confirmed, all the procedures to be per- often caused by compressive syndromes such as discal hernias. formed during the study were elucidated, and the subjects Such compressions often result in neuropathic pain, which is signed the Free and Informed Consent Term (FICT), accor- characterized by spontaneous burning pain, followed by allo- ding to Resolution 466/12 of the National Health Council dynia and hyperalgesia, which can be observed in the nerve - Brazil, confirming their participation in the research. pathways of the lower limbs6. After fulfilling the eligibility criteria, a clinical evaluation and In addition to pharmacological and surgical treatments, there assessments of pain intensity, spinal mobility, and hip gonio- are noninvasive or nonpharmacological treatments, such as metry were carried out, and a quality of life questionnaire was physiotherapy. In regard to existing physical therapy treat- applied. ments, they can lead to the reduction of pain and muscle ten- Sixteen volunteers participated in this study and were treated sion, as well as a possible increase in range of motion. One with NM technique. of the available treatments is neural mobilization (NM), whi- To preserve the accuracy of the intervention effectiveness, ch is characterized by a set of techniques that aim to impo- participants who missed more than two sessions were exclu- se greater tension in the peripheric nervous system through ded from the study. All the subjects were assessed by a blinded certain postures; slow and rhythmic movements are applied evaluator. Both participants and evaluators were encouraged to the peripheral nerves and spinal cord, improving nerve im- not to discuss the intervention. pulse conduction8-12. Studies have demonstrated the beneficial effects of NM, in- Intervention cluding improved joint pain in patients with rheumatoid The NM was performed by the same physiotherapist from arthritis13 and improved cervicobrachial pain14. NM has de- the first to the last session on alternate days. Treatment with monstrated an excellent prognosis in patients with neuropa- the technique consists of applying a total of 10 interventions thic pain, in addition to presenting other advantages such as in each patient, with a total duration of 10 minutes, divided low operational cost, easy application and no adverse effects. into four series of 2 minutes each, with a 30 second interval Results from the previous studies described above show the be- between each series, according to the protocol proposed in neficial effects of NM treatment. 2012 by the study15 and adapted from Butler10. The research questions were: The technique was applied with the participant seated in a 1. Is NM effective to decrease pain and improve motor beha- o vior on individuals with chronic low back pain? suitable chair, with a flexed hip (90 ) and extended knees. 2. Is NM able to interfere on cytokines modulation? Next, the physiotherapist applied the technique only to the The objective of this study was to evaluate the effect of NM lower limb which presented some impairment due to low on individuals with chronic low back pain, as well as analy- back pain, observed in the previous physical examination; in ze possible changes in pain, motor behavior and on cytokine case of absence of pain radiation to any of the limbs, the tech- quantification before and after treatment. nique was applied only to the right lower limb, according to the study15 (Figure 1). METHODS Sample size During the period from July 2016 until September 2017 sixty The sample size was calculated based on the VAS for pain, subjects were screened for eligibility. Sixteen individuals com- which was considered the primary end point. To this end, pleted the entire study protocol according to the inclusion the variance reported in the study16, whose objective was to and exclusion criteria. evaluate NM as a technique for treatment. Considering the Individuals of both sexes who met the following criteria were mean and standard deviation of the pre-intervention and pos- included in the study: presence of chronic low back pain, ra- t-intervention of the present study, with an alpha value (α) diating or not to one of the lower limbs; age 18 years or older; of 0.05 and 90%, it was determined that 20 subjects were score ≥ 4 on the visual analog scale (VAS). required for the experimental group. 206 Effects of neural mobilization on individuals with chronic low back pain BrJP. São Paulo, 2020 jul-sep;3(3):205-12

tionnaire must be self-filled by the volunteers, demonstrating their success or difficulty in performing their daily life tasks associated with their pain, and the result of the questionnaire is the sum of the positive or marked responses. As some patients had some difficulty reading or understanding the instructions of the questionnaire, the reading was done together with the researchers.

World Health Organization Quality of Life Questionnaire In order to standardize the evaluation of the patients life quality, the WHOQOL-bref questionnaire was used, which consists of a short and quick application questionnaire developed by the World Health Organization (WHO). The WHOQOL-bref consists of a total of 26 questions, divided into physical, psychological, social relations and environment domains. In order to access the quality of life before and after the proposed treatment, this questionnaire was applied in two periods, the initial measurement (IM), before any treatment, and at final measurement

Figure 1. Representation of the application of neural mobilization (FM) after the end of 100 sessions of treatment. 20 1 – with the patient sitting on a regular chair, the leg to be treated is raised This questionnaire was evaluated by the method developed by , until the lower limb is completely extended; 2 – after adduction followed by a questionnaire analysis that uses Microsoft Excel to identify the internal rotation, extension is continued until the patient experiences some discomfort (not necessarily pain); 3 and 4 – alternation between movements means and standard deviations for each individual and unify of dorsiflexion and plantar flexion, approximately five times each; 5 and 6 – at them in a graph, ranging from zero to 100, and contains all do- the end, the lower limb is elevated and depressed alternately, approximately five times. Steps 3-4 and 5-6 must be alternated until the end of each series mains analyzed by the questionnaire. of two minutes each. Visual analog scale Outcome measures The VAS was used for the assessment of pain intensity; it consists First, all personal data from each subject was obtained, including of a line ranging from zero to 10, where zero represents the ab- age, occupation and education. After this first step, participants sence of pain and 10 represents the worst pain. After instructions were submitted to two evaluations, one prior to and one at the on how to use the scale, volunteers were asked to mark a point on end of the therapeutic program. Both evaluations assessed quality the line that indicated the intensity of pain that they were feeling of life Oswestry Disability Index (ODI), Roland-Morris Disabi- at the moment of evaluation21. lity Questionnaire (RMDQ) and the World Health Organization Quality of Life Questionnaire-bref (WHOQOL-bref), pain in- Mobility of the lumbar spine tensity, mobility of the lumbar spine and cytokines measures. Two tests were used to evaluate the mobility of the lumbar spine: the third finger to the ground and goniometry. Oswestry Disability Index The test of the third finger to the ground distance consists of an The ODI Index version 2.0, validated in Portuguese in 200717, was active test in which the individual is placed in an orthostatic po- used. The scale consists of a list of 10 questions with six possible sition, with feet separated in line with the hips, keeping the knee answers. Each answer has a score ranging from zero to 5 in the extended and heel touching the ground. Then, the participant is order in which they are listed, that is, the first value is zero and asked to perform trunk flexion with the arms extended and to the last value is 5. The first question assesses pain intensity and the try to bring his hand closer to the ground. Then, using a tape others assess the effect of pain on performance of activities of daily measure, the distance between the tip of the third finger and the living, such as personal chores, dressing, sleep and so forth18. ground is measured, and the value in centimeters is considered The total score obtained on this questionnaire was analyzed using the mobility of the volunteer’s lumbar spine1,22. a mathematical formula. After adding all the individual’s scores Goniometry refers to the measurement of individuals’ joint angles; from the questionnaire, the total score as a percentage for each vo- it was applied before the first session and after the last session of lunteer was calculated. The total score was divided by the number NM. To minimize measurement error, the physiotherapist in charge of answered questions multiplied by 5. The result of this division underwent training. Goniometric measurements of the hip joint of was multiplied by 100, and the final values are given in percenta- the participants in this study were used for both thigh flexion; the ges ([score ÷(number of answered questions × 5)] × 100)18. amplitude varies between zero - 131°±6.4°, and the articular range varies from zero to 13°±5.4°; measurements may vary from indivi- Roland-Morris Disability Questionnaire dual to individual more or less within these established values23. The Portuguese version of the RMDQ was applied to the subjects of the study19. The questionnaire consists in assessing the severity Cytokines measurements and level of physical disability induced by low back pain through Blood was collected from each group to evaluate the possible im- 24 alternatives with dichotomic answers (yes or no). The ques- pact of the technique on pro- and anti-inflammatory cytokines. 207 BrJP. São Paulo, 2020 jul-sep;3(3):205-12 Ramos M, Cruz CA, Laurentino MF, Ashmawi HA, Santos FM and Chacur M

Two collections were performed: the initial measurement (I) and interval between 61 and 80% characterizes crippling back the final measurement after the last session (F) of treatment. To pain. Finally, the interval between 81 and 100% characterizes evaluate cytokine concentration, the blood serum of the indivi- bed bound immobility. duals was used for these analyses. Regarding the patients that participated in the present study, For specific IL-1β, IL-4, IL-6, and TNF-α cytokines, specific one was in level 4 and one in level 3, with a high level of di- reagents contained in the Milliplex®TM Map kit (Millipore Cor- sability, and the other patients had an average score between poration, Darmstadt-Germany) were assessed by Multiplex (En- stages 2 and 1, with moderate disability. In the final measure zyme-Linked Immunosorbent Assay) according to the protocol (F) of the ODI questionnaire, the effect of treatment on chan- specified by the manufacturer. ges in clinical condition after application of the mathematical All the study procedures were conducted in accordance with the formula was evaluated. Comparing the initial (I) and final (F) Ethics Committee involving humans of the Universidade de São measurements of ODI, an improvement on the clinical condi- Paulo Instituto de Ciências Biomédicas – São Paulo, Brazil (CAAE: tion in all subjects was observed; many of the individuals analy- 56978016.1.0000.5467). The trial was also registered in Clinical zed after the treatment obtained an excellent response with the Trials (clinicaltrials.gov - NCT02671409). proposed protocol. All patients decreased in disability by one stage, and by the end of the program almost all subjects reached Statistical analysis the first stage, in the range of 0 to 20%, which classifies the Results are presented as the mean±SEM. Statistical analyses of change as excellent (Table 1). data were generated using GraphPad Prism, version 5 (Graph- -Pad Software Inc., San Diego, CA). Statistical comparison was Table 1. Analysis of the results obtained in the initial (I) and final (F) measurements on the Oswestry Disability Index, before and after the performed using a paired t-test. In all cases, p<0.05 was conside- proposed treatment red statistically significant. Measure 0-20% 21-40% 41-60% 61-80% 81-100% RESULTS Initial 7 7 1 1 0 Final 14* 1* 1 0 0 The symbols represent the statistically significant difference between values In figure 2 shows the characterization the study’s subjects. Si- prior and after treatment * p<0.05. xty subjects were screened for eligibility and only 16 individuals completed the entire study protocol according to the inclusion Roland-Morris Disability Questionnaire and exclusion criteria. From those 16 individuals, 8 were Men In this questionnaire, positive answers and a value equal to or and 8 Women, with age between 25 to 45 years old. lower than 10 points indicates that the person with low back pain presents a small level of disability, that is, despite the pain, there is no impediment of daily life tasks. When the total varies Number of volunteers between 11 and 14 alternatives indicated as positive, mild or mo- n=60 derate inability to perform daily activities is present. When the positive responses are equal to or greater than 15, the individual Anamnesis has severe disability. In the initial measurement, 14 individuals presented the Volunteers selected normal parameter, not showing any kind of incapacity in Number of volunteers not to Neural Mobilization performing daily life activities. In the initial measurement, selected n=24 treatment n=36 two individuals from the same group presented severe incapacity to perform daily activities. At the end of treatment, this questionnaire was reapplied, and 15 of the subjects presented Number of volunteers who normal parameters, while one of the individuals with severe completed the treatment n=16 disability returned to normal levels; the other individual who also presented severe level of disability partially reversed their Figure 2. Characterization of the subjects for the present study condition, reaching mild/moderate disability when performing daily activities(Table 2). Oswestry Disability Index Table 2. Analysis of the results obtained in the initial (I) and final (F) After the initial measurement of ODI, the mathematical measurements on Roland-Morris Disability Questionnaire (RMDQ), formula was applied to evaluate the degree of incapacity of before and after the proposed treatment the individuals. In the initial measure (I), the ODI can be Time 0 to10 - 11 to 14 – Mild/ 15 to 24 – Severe classified into five levels or stages of disability. The first le- Normal Moderate disability disability vel, between zero and 20%, characterizes a minimal disabi- Initial 15 0 2 lity associated with the activities. The second stage, between Final 16 1 0* 21 and 40%, characterizes a moderate disability. The interval The symbol represents the statistically significant difference between values between 41 and 60% characterizes a severe disability, and the prior and after treatment * p<0.05. 208

Effects of neural mobilization on individuals with chronic low back pain BrJP. São Paulo, 2020 jul-sep;3(3):205-12

World Health Organization Quality of Life 10 In the WHOQOL-bref questionnaire an important reduction, 9 mainly in the physical and environment domain, when compa- 8 ring before and after treatment, was observed. In the psychologi- 7 cal and social relations domains, no changes during the analyzed 6 * period were observed (Figure 3). * 5 * * 4 * Initial * 3 * * *

Physical 64.63% Visual analog scale 2 * 1 Psychological 57.94% 0 st nd rd th th th th th th th Social I 1 s 2 s 3 s 4 s 5 s 6 s 7 s 8 s 9 s 10 s F 55.16% relationship Interventions

Environment 60.12% Figure 4. Pain intensity measured by visual analog scale (I=initial measure), during (s = sessions) and after (F=final measure) treatment with NM (n=18). The symbols represent the statistically significant difference Total 59.43% between times analyzed and initial measure * p<0.0001. Data is presented as the mean±SEM. 0 10 20 30 40 50 60 70 80 90 100

Final formed again to ascertain the effectiveness of the treatment, and Physical 60.54%* a mean of 15.4 cm distance to the ground was obtained. This improvement was statistically significant for lumbar spine mo-

Psychological 57.14% bility after treatment according to the protocol (*p<0.04). This result leads us to suggest that the NM could improve the lumbar Social 54.37% mobility of individuals with chronic low back pain by approxi- relationship mately 25.5% (Figure 5).

Environment 57.29%* 25

Total 57.78% *p < 0.04 20 * 0 10 20 30 40 50 60 70 80 90 100 15 Figure 3. Analysis of the results obtained in the initial and final measurements on the WHOQOL-bref questionnaire. The symbols represent the statistically significant difference between values 10 prior and after treatment for each domain * p<0.05. (distance + cm) 5 finger to the ground test finger to the ground rd Pain intensity 3 0 As shown in figure 4, when the means obtained for each period I F were analyzed, the initial score (I) was 7.16 for the VAS, indica- Interventions ting moderate intensity pain. Beginning with the second inter- Figure 5. Mobility of the lumbar spine by the third finger to the vention session with the NM, a statistically significant difference ground test was already observed in relation to the initial measurement (I) I - measurement initial; F = measurement final. until the final treatment (F) (*p<0.001). On the final measure, that is, after 10 sessions of NM, the individuals presented a score Lumbar spine mobility before (I=initial measure) and after (F=- equal to 1.61 for the VAS, nearly the lowest score possible on the final measure) treatment. The symbols represent the statistically scale. Therefore, it is suggested that the NM was able to reduce significant difference between groups * p<0.04. Data is presented the pain intensity of individuals with chronic low back pain by as the mean±SEM. approximately 70% compared to initial pain intensity. Hip goniometry Mobility of lumbar spine: Before treatment, a mean hip flexion of 87.92°, measured by hip Third finger to the ground test: flexion in dorsal decubitus, as shown in figure 6A, was observed. Before treatment, in the initial measurement (I), individuals’ Subsequently, the subjects started treatment with the NM. At average pretreatment distance to the ground was 20.67cm. Sub- the end of treatment, a final measurement (F) was performed sequently, these same individuals started treatment with the to ascertain the effectiveness of the treatment. At the end of the NM. At the end of the 10 interventions of NM treatment (final 10 interventions with the NM technique, an average of 98.57° measurement F), the mobility of the lumbar spine test was per- of hip flexion was observed. This improvement was statistically 209 BrJP. São Paulo, 2020 jul-sep;3(3):205-12 Ramos M, Cruz CA, Laurentino MF, Ashmawi HA, Santos FM and Chacur M significant for goniometry after treatment with the proposed Furthermore, analysis of the cytokine IL-6, which is considered protocol (*p<0.04). a pro-inflammatory and modulatory cytokine, showed a statisti- Additionally, regarding measurement of hip extension in the cally significant increase at the final measurement (F) compared ventral decubitus, as shown in figure 6B, on initial measurement to the initial measurement (before NM treatment) (*p<0.009) (I), observed an average of 13.8° of hip extension was observed. (Figure 7C). Analysis of the anti-inflammatory cytokine IL-4 At the end of treatment, a mean hip extension of 18.2° was ob- (Figure 7D) revealed a significant difference before (I) and after tained. This improvement was statistically significant for gonio- (F) the application of treatment, that is, an increase in this cyto- metry after treatment with the proposed protocol (*p<0.04). kine after treatment (* p<0.03).

A B DISCUSSION 150 50 * * Low back pain can lead to disability over time and represents an 100 20 important economic impact24,25. Based on the present study results, it’s suggest that the NM tech- 50 10

Hip flexion (º) nique, when applied in individuals with chronic low back pain, Hip extension (º) 0 0 either alone or combined with pharmacological therapy, is able I F I F Interventions Interventions to improve quality of life, reduce pain intensity, increase functional mobility, as well as provide a huge decrease in pro-inflamma- Figure 6. Goniometry of hip flexion (A) and hip extension (B) Before (I=initial measure) and after (F=final measure) treatment. The symbols tory cytokines. represent the statistically significant difference between groups * p<0.04. Data The ODI questionnaire was used to measure the disability level is presented as the mean±SEM. for all subjects. Although patients were mostly classified at the stage two level of disability before applying the technique, a re- Cytokines duction in the level of disability of all subjects was observed after Regarding the cytokine assay, the involvement of pro- and an- application of the protocol. Furthermore, success in improving ti-inflammatory cytokines (Figure 7) was evaluated. In relation the quality of life of all study patients was achieved. to pro-inflammatory cytokines, IL-1β, IL-6, and TNF-α before The RMDQ is used to analyze the level of physical disability and after the last session of NM treatment were analyzed. The induced by low back pain. In the present work, it’s suggested that results show that there was a statistically significant decrease in the proposed protocol was able to improve disability of almost all IL-1β and TNF-α concentrations (Figures 7A and B, respecti- treated individuals from mild to normal. vely) between the initial (I) and final (F) means, that is, before Important improvement in quality of life according to the and after the application of the treatment protocol. WHOQOL-bref questionnaire was also observed. The treatment was able to improve the physical domain after the last session of NM treatment. This domain includes the perception of pain and discomfort in the patients’ lives, and is associated with other fac- A IL-1b B FTN-a tors such as fatigue, mobility and sleep. Regarding environment domain, there was a reduction in the final measure compared to F F initial measure, but this difference is attributed to the interpreta- tion of individuals before the analyzed questions. No difference Measures I Measures I was observed in the psychological and social relations domain between the two periods where the questionnaire was applied. 26 0 50 100 150 200 0 50 100 150 200 These data corroborate the data found by the study , whose au- pg/mL pg/mL thors observed, using the WHOQOL-bref questionnaire, that the physical domain was the most intensely altered, and suggested that this change was strongly associated with the individuals’ C IL-6 D IL-4 level of disability. Regarding the pain scale, significant improvement in the pain F F of patients treated with the NM technique was observed. All individuals had significant improvement, an average of 70% re-

Measures Measures duction in pain after the treatment, evaluated by the VAS. The I I present study results corroborate authors who observed impro- 27 0 2000 4000 6000 0 100 200 300 400 500 vement in pain in all individuals with sciatic nerve injury and pg/mL pg/mL low back pain2,8. The present work also corroborates findings obtained by by the Figure 7. Concentration of cytokines IL-1β (A), FTN-α (B), IL-6 (C) and IL-4 (D). sudies24,28, who observed a reversal of allodynia and hyperalgesia Measurement before- initial (I) and after-final (F) NM treatment. The symbols represent the statistically significant difference between groups; * p<0.04. Data and an improvement in the range of motion of the affected limb is presented as the mean ± SEM. after the NM technique. 210 Effects of neural mobilization on individuals with chronic low back pain BrJP. São Paulo, 2020 jul-sep;3(3):205-12

When the functional capacity of all patients was analyzed, an Limitations of this study improvement in their mobility was observed. A statistically signi- Limitations regarding regarding the recruitment and maintenan- ficant improvement in the mobility of the lumbar spine, evalua- ce of patients to adhere the treatment were encountered, since ted through the third finger distance and the hip goniometry most showed a rapid improvement in their initial condition, evaluation tests, was observed. Results showed an average of 25% abandoning treatment before its end. Another limitation is the increase in lumbar spine mobility, a large and statistically signifi- treatment schedule of three times a week, which can coincide cant improvement after treatment. An improvement in the joint with the patients obligations and work hours. Another limitation angles of the individuals treated with NM for both flexion and foreseen by the study is that the individuals to be recruited for extension was also observed. This improvement was approxima- treatment must have a level of education which allows them to tely 24.17% for extension and 10.8% for flexion. read, interpret and answer the quality of life questionnaires. All It should be mentioned that the authors also observed impro- the limitations listed above do not prevent the work from being vement in patients’ mobility using the Shober’s test, another si- carried out, however, they have limited the number of indivi- milar clinical test to assess lumbar mobility. Recent studies also duals who are able to be recruited for treatment. observed statistically significant improvement in lumbar mobility in individuals treated with NM after sciatic nerve injury29 or CONCLUSION after low back pain8. Since improvement in patients’ pain severity and motor status The treatment with NM implemented in the present study reduced associated with the NM technique was observed, serum concen- the pain intensity and increased the lumbar mobility of individuals tration of cytokines was then evaluated. It is already known that with chronic low back pain, which in general accelerated the process pro-inflammatory cytokines are involved in hyperalgesia and al- of improvement/recovery of the functional capacity of these indivi- lodynia generation due to compressive syndromes. Studies have duals and accelerated their return to activities of normal daily life. already demonstrated an increase in pro-inflammatory cytokines Furthermore, the protocol used in the study significantly impro- in the blood and tissues of individuals and animals with neuro- ved the patients’ quality of life and indicated a change in con- pathic and chronic pain30. centration of pro and anti-inflammatory cytokines at the end of The present study results demonstrated a decrease in pro-in- treatment with NM in individuals with chronic low back pain. flammatory cytokines and an increase in anti-inflammatory cy- It’s worth noting that the NM can also be combined with other tokines after NM treatment. A decrease in IL-1β and TNF-α noninvasive conventional treatments, such as pharmacological and an increase in IL-4 pro- and anti-inflammatory cytokines treatment, which also makes it a coadjutant tool in the treatment was observed. 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212 BrJP. São Paulo, 2020 jul-sep;3(3):213-6 ORIGINAL ARTICLE

Green medicinal clay in the treatment of the unspecified lumbar pain: clinical trial Argila medicinal verde no tratamento da dor lombar inespecífica: ensaio clínico

Mariana Terezinha Delfino1, Graciela Mendonça da Silva de Medeiros2, Aline Daiane Schlindwein3

DOI 10.5935/2595-0118.20200046

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: Lower back pain is one JUSTIFICATIVA E OBJETIVOS: A dor lombar é uma das of the musculoskeletal diseases with the highest incidence all doenças musculoesqueléticas de alta incidência em todo o mun- over the world. In approximately 85% of the cases it is classified do. Aproximadamente em 85% dos casos ela é classificada como as unspecified, which means that it has no evident cause. With inespecífica, significando que não tem uma causa evidente. that in mind, geotherapy is a non-invasive technique that allows Diante disso, a geoterapia é uma técnica não invasiva que possi- control over the lower back pain. The goal of this study was to bilita controle da dor lombar. O objetivo deste estudo foi avaliar evaluate the results of geotherapy on the relief of the unspecified os resultados da geoterapia no alívio da dor lombar inespecífica. lower back pain. MÉTODOS: Ensaio clínico, semi-experimental, do tipo antes METHODS: Semi-experimental quantitative clinical trial, com- e depois, de natureza quantitativa, que incluiu 26 participantes paring before and after states, including 26 participants who re- que receberam quatro sessões de cataplasma de argila verde na ceived four applications of green clay cataplasm on the lower região lombar com intervalo de sete dias. A intensidade da dor back region with an interval of seven days. The pain intensities antes e depois das intervenções foi avaliada pela escala analógi- before and after the interventions were evaluated by a visual ana- ca visual e questionário Oswestry Disability Index. Para análise log scale and an Oswestry Disability Index questionnaire. For the dos dados foram utilizados os testes: Kolmogorov-Smirnov e t de data analysis, the Kolmogorov-Smirnov and t Student methods Student, com nível de significância de 5% (p<0,05). were used, with a significance level of 5% (p<0.05). RESULTADOS: Houve significância estatística com a geoterapia RESULTS: There was significant statistics that showed lower na modalidade cataplasma lombar com argila verde no alívio da back pain relief with the cataplasm mode geotherapy using green dor lombar, obtendo-se p=0,0001 para a escala analógica visual. clay, reaching p = 0.0001 in the visual analog scale. CONCLUSÃO: A geoterapia com argila verde aplicada na região CONCLUSION: The geotherapy with green clay applied on the lombar foi efetiva na redução da intensidade da dor lombar crô- lower back region of the body was effective on diminishing of the nica inespecífica. unspecified chronic lower back pain. Descritores: Dor crônica, Dor lombar, Terapias complementares. Keywords: Chronic pain, Complementary therapies, Low back pain. INTRODUCTION

Unspecified back pain (BP) is defined as pain or dysfunction with no specific or clear cause, reaching 85% of BP occurrences1. It’s a multidimensional phenomenon, encompassing physical and emotional suffering, functional disability and restriction of social participation, due to organic, psychological and social fac- Mariana Terezinha Delfino – https://orcid.org/0000-0001-5335-5700; tors. Several guidelines have pointed to the importance of biop- Graciela Mendonça da Silva de Medeiros – https://orcid.org/0000-0001-5438-057X; Aline Daiane Schlindwein – https://orcid.org/0000-0003-0996-6242. sychosocial treatment, because it contributes to the relief of the patient’s pain2. 1. Universidade do Sul de Santa Catarina, Curso de Naturologia, Palhoça, SC, Brasil. 2. Universidade Federal de Santa Catarina, Doutoranda do Curso de Enfermagem, Flori- In this regard, non invasive lumbar cataplasm geotherapy using anópolis, SC, Brasil. green clay was chosen. This modality is indicated for the im- 3. Universidade do Sul de Santa Catarina, Programa de Pós-graduação em Ciências da Saúde, Palhoça, SC, Brasil. provement of vascularization, oxygenation and local tissue nutrition, offering pain relief3. Submitted on November 13, 2019. Geotherapy, geo – earth, clay; therapy – treatment, a practice Accepted for publication on May 12, 2020. Conflict of interests: none – Sponsoring sources: none. that uses medicinal clay as an intervention method, is a healing integrative therapy, based on the biophotonics, bioelectri- Correspondence to: Rua São Judas Tadeu, nº 489 - Comasa city, piezoelectric and mineralizing theories, which acts on all 89228-060 Joinville, SC, Brasil. aspects of the individual, resulting in a state of balance, rela- E-mail: [email protected] xation and harmony, favoring health. Green clay is applied in © Sociedade Brasileira para o Estudo da Dor cases of imbalance and in cases of chronic diseases and/or pain, 213 BrJP. São Paulo, 2020 jul-sep;3(3):213-6 Delfino MT, Medeiros GM and Schlindwein AD such as joint pain, resulting from chronic inflammatory proces- World Medical Association and respected the Resolution ses, as well as in BP and cervical pain, for its analgesic, anti-in- 466/12 of the National Health Council5, which determines flammatory, balancing properties as well as helping homeostasis3. the Guidelines and Regulatory Standards for Research in an According to the Ministry of Health, geotherapy is a simple prac- experimental unit involving human beings, meeting the re- tice, with a well-defined, safe, non-invasive history. It’s effective in quirements of the Free and Informed Consent Term (FICT). clinical studies and can be used in inflammatory processes, injuries, There were 4 sessions of green clay application and pain inten- healing, lesions and in osteomuscular diseases3. This therapy was sity assessment by the visual analog scale (VAS), and in the first included in the Política Nacional de Prática Integrativas e Comple- and last sessions the data collection instruments were filled. mentares (PNPIC) by ordinance number 702 of March 21, 20184. In the first session, the participant filled out the questionnai- The objective of the present study was to evaluate the results of re for sociodemographic characteristics survey and the ODI geotherapy in the relief of non-specific BP. questionnaire for BP evaluation. Afterwards, the patient was placed on a stretcher in ventral decubitus position, clothes METHODS and adornments were removed, and the skin was prepared for the application of the clay with gentle exfoliation performed A quantitative, exploratory clinical trial, with longitudinal tem- three times, using warm wet gauze at T12 to the sacral region. porality, comparing before and after, which includes students The green clay, at a tepid temperature, 2 cm thick, was pla- and collaborators of Universidade do Sul de Santa Catarina ced on the gauze moistened with a spatula from T12 to the (UNISUL). The sample is non probabilistic, recruited from the sacral region, which was covered with paper towel. Sheet was university by the means of flyers and Facebook and Instagram covering the entire body of the individual. After 40 minu- social networks. Thirty individuals where included and allocated tes, the gauze and the clay residues were removed with moist in one treatment group. After the second session, four partici- gauze and cotton and the area was dried with paper towels. pants were excluded for not attending to the next appointments, The second and third sessions occurred respectively 7 and 14 so the study was concluded with 26 participants, from February days later, following the same procedure, but the clay remai- to March 2019 (Figure 1). ned in the body for 40 minutes. The fourth and last sessions The inclusion criteria were: to be a student and/or collabo- took place 7 days after the third session, and after applying rator of UNISUL or to be on the waiting list of the School the clay for 40 minutes, the participant filled out the socio- Clinic; to have BP; to be between 18 and 59 years old. The demographic questionnaire and the ODI questionnaire. exclusion criteria were: to have a skin lesion in the place whe- The research was performed at the UNISUL School Clinic of re the clay would be applied; to use topical drugs in the pla- Naturology, under approval of the Research Ethics Committee ce where the clay would be applied; to use opioids. The stu- number 3.101.272 and CAAE 04555218.6.0000.5369. dy is in accordance with the Declaration of Helsinki of the Statistical analysis Mean and median pain intensity were calculated and for the ODI questionnaire the GraphPad Prism (version 4) was used. Eligibles The data were tested for normality using the Kolmogorov-Smir- (n=30) nov test and submitted to the Student’s t test with a significance level of 5% (p<0.05).

Treatment group RESULTS (n=30)

There were 19 female and 7 male volunteers, aged between 19 1st intervention and 55. Regarding the use of analgesics, 88.46% of the participants declared not to use it and 11.54% used only when necessary (during the research they didn’t use it). From the partici- 2nd intervention pants, 7.69% declared to have between 3 and 5 hours of sleep, Excluded 4 69.23% declared to have between 5 and 7 hours, and 23.08% declared to have between 8 and 10 hours. Regarding the most rd 3 intervention frequent position on their day, 88.46% claimed to remain seated. The style and quality of life characteristics of the group 4th intervention stands out in the information raised by the sociodemographic questionnaire, which made it possible to raise the information that 61.54% practiced physical activity and 42.31% said they Results analysis worked 6 to 8h a day. There was a significant decrease in pain after the first ses- Figure 1. Flow diagram of participants during each stage of the re- sion, with mean pain before application of 4.54±2.319 and search after 1.81±2.350, with statistical significance (p=0.0001). 214 Green medicinal clay in the treatment of the BrJP. São Paulo, 2020 jul-sep;3(3):213-6 unspecified lumbar pain: clinical trial

In the second session the mean pain before application was through which free electrons, present in minerals, translate the 4.42±2.120 and after 1.46±1.985, with statistical significance therapeutic properties of the clay. Therefore, within the physi- (p=0.0001). In the third session the mean pain before appli- cal-chemical properties, the energy potential of geotherapy is cation was 3.04±2.200 and after 1.12±1.862, with statistical based on the piezoelectric effect, caused by crystalline structu- significance (p=0.0001). In the fourth session the mean was res of SI4+ free silica and clay minerals3. The friction of the clay 2.62±2.844 and after 0.73±1.845, with statistical significance crystalline structures, induced by proper handling, generates (p=0.0001). Regarding the mediate effects, the mean pain be- electrical charge by piezoelectric effect and activates the vibra- fore application in the first session was 4.54±2.319 and after tional system, in charge of stimulating the skin and maintai- application in the last session was 0.73±1.845, with signifi- ning the energetic action. In turn, the mineralizing theory, a cance level (p=0.0001). result of the varieties and concentrations of elements, ensured by the radioactive and intrinsic properties, can perform ion exchange between the clay and the skin3. p<0.0001 The chemical components found in green clay are: sodium oxide, zinc, potassium monoxide, aluminum oxide, magnesium, manganese, copper, aluminum, silicon, molybdenum, tita- nium oxide, lithium, sodium and potassium, ensuring analgesic, anti-inflammatory, decongestant and healing property3-11. The study6, which performed chemical analysis of several clays, found that green clay presents the greatest diversity of ele-

Intensity of pain ments, including iron oxide, related to magnesium, calcium, potassium, manganese, aluminum, phosphorus and silicon. The data showed that 88.46% of the participants remained seated most of the day. A study7 conducted with 52 individuals who worked seated showed that 83% had BP, which allows us to infer 1 after 2 after 3 after 4 after 1 before 2 before 3 before 4 before that this position can trigger the pain, since when the sitting position is maintained for a long period, it can generate some Sessions muscle and joint deficit, interfering in the mobility, flexibility Figure 2. Pain intensity evaluated by the visual analog scale and exhaustion of the spine’s posterior muscles, which can interfere with its alignment and stability. When seated, the individual In regards to the ODI questionnaire, the initial mean pain was may be in an inadequate position for a prolonged period without 41.23±12.160 and the final mean was 33.31±7.918, correspon- lumbar and forearm support, in addition to anterior torso fle- ding to the statistical significance level p=0.001 (Figure 3). xion, which intensifies the pressure on the intervertebral discs by more than 70%, increasing the likelihood of pain7. By decreasing inflammatory processes and osteomuscular lesions, geotherapy p<0.0001 provided pain relief2. A study conducted with university students showed that 66% reported pain in the lumbar region and the sitting posture for a long period during class was a variable that may be related to the presence of muscle imbalances and pain, especially in the spine8. 61.54% of participants reported doing physical activities, which allows us to infer that the practice of physical activity

Intensity of pain does not contribute to the relief of the BP. However, the reason for the physical activity was not evaluated, and it could have been performed for pain relief or, also, that the pain itself could be due to the practice of physical activity. A stu-

After dy involving data from the 2013 Pesquisa Nacional de Saúde Before (PNS - National Health Research) found that intense physical Figure 3. Intensity of pain by the Oswestry Disability Index questionnaire activity in the workplace and at home, in both sexes, is not beneficial to health, since it increases muscle and joint over- DISCUSSION load, in addition to fatigue, which can lead to osteomuscular problems9. The results showed that the application of green medicinal On the contrary, another research done with physiotherapy clay in the lumbar area contributed significantly to the relief students assessed that 60,5% of the participants did not prac- of the unspecific BP, in an immediate and mediate manner. A tice physical exercises and, from those, 60,9% presented BP – relevant aspect refers to the theories that underpin geotherapy, suggesting that the practice of physical activities could be a factor in which there is a relationship of ionic or radionic exchange of prevention, since it helps to strengthen the muscles10. 215 BrJP. São Paulo, 2020 jul-sep;3(3):213-6 Delfino MT, Medeiros GM and Schlindwein AD

Chronic lumbar pain restricts daily activities and also creates It is essential to conduct more studies with a larger sample and control anxiety due to the sensation of unproductivity, disability and group, a limiting factor of this study, in order to assess the possibi- the reduction of independence. These restrictions, truly disturb lity that the placebo effect did influence or not the results obtained. adults in the economic active age, since they result in reduction of functional working capacity and execution of daily activities, CONCLUSION influencing on quality of life8. Such problem leads to high demand for health services, consequently generating high social Geotherapy with green clay applied to the lumbar area was effec- costs, decreased productivity, absence from work and, as a result, tive in the reduction of the unespecified lumbar pain intensity. costs on welfare9,11. Since most individuals in this research did not use anal- REFERENCES gesics, it is possible to infer that clay may have contributed to BP relief. A study conducted in a patient with se- 1. Silveria APB, Nagel LZ, Pereira DD, Morita AK, Spinoso DH, Navega MT, et al. Efeito imediato de uma sessão de treinamento do método Pilates sobre o padrão de cond-degree burns used gray medical clay as a form of cocontração dos músculos estabilizadores do tronco em indivíduos com e sem dor treatment and provided relief from pain and burning, in ad- lombar crônica inespecífica. Fisioter Pesqui. 2018; 25(2):173-81. 12 2. Desconsi MB, Bartz PT, Flegenbaum TR, Candotti CT, Veira A. Tratamento de pa- dition to assisting in the inflammatory process of burning . cientes com dor lombar crônica inespecífica por fisioterapeutas: estudo transversal. Considering that 42.31% of the studied individuals worked six Fisioter Pesqui. 2019;26(1):15-21. to eight hours a day, it is possible to infer as a possible cause 3. Medeiros G, Marimon R. Geoterapia nos cuidados a saúde. In: Hellmann F, Rodri- gues DMO Termalismo e Crenoterapia. Palhoça: Editora Unisul; 2017. 331-49p. of pain the length of working hours. A study that analyzed the 4. Ministério da saúde (Brasil). Portaria número 702 de 21 de março de 2018. Altera a prevalence of musculoskeletal pain in nursing professionals fou- Portaria de Consolidação nº 2/GM/MS, de 28 de setembro de 2017, para incluir no- vas práticas na Política Nacional de Práticas Integrativas e Complementares – PNPIC. nd that those who had a weekly workload between 30 and 42 Diário Oficial União. 22 mar 2018; Seção 1:65. hours had greater pain complaints, especially in the lower part of 5. Ministério da Saúde (Brasil). Conselho Nacional de Saúde. Resolução n. 466, de 12 13 de dezembro de 2012. Aprova diretrizes e normas regulamentadoras de pesquisas en- the spine . Yet another research with physiotherapy and psycho- volvendo seres humanos. Brasília, Diário Oficial da União, 12 de dezembro de 2012. logy academics showed that 80.7% had back pain and remai- 6. Biriti BMAB, Buriti JS, Cartaxo JM, Neves GA. Estudo das propriedades estruturais, ned seated, eventually in an inadequate manner, for long hou- térmicas, químicas e granulométricas de argilas com perspectivas em tratamentos me- dicinais, terapêuticos e estéticos. In: 14º Congresso da Sociedade Latino Americana de 14 rs, which may have contributed to the development of pain . Biomateriais, Órgãos Artificiais e Engenharia de Tecidos. Maresias; 2017. 585-94p. Another study designed to analyze the relationship between 7. Silva JN, Cusatis Neto R. Prevalência de dor lombar em pessoas que trabalham na postura sentada. UNILUS Ensino e Pesquisa. 2016;13(32):67-75. sleep disorders and the occurrence of chronic non-commu- 8. Gomes Neto M, Sampaio GS, Santos OS. Frequência e fatores associados a dores nicable diseases, found that 31.4% suffered from altered sleep musculoesqueléticas em estudantes universitários. Rev Pesq Fisioter. 2016;6(1):26-34. 15 9. Malta DC, Oliveira MM, Andrade SSCA, Caiaffa WT, Souza MFM, Bernal RTI. and lower back pain . In the same line of research, a study car- Factors associated with chronic back pain in adults in Brazil. Rev Saude Publica. ried out in Korea showed that the presence of muscular pain 2017;51(Suppl 1):9s. was significantly greater in those who slept for 5 to 7 hours, 10. Morais ML, Silva VK, Silva JM. Prevalence of low back pain and associated factors among physiotherapy students. BrJP. 2018;1(3):241-7. concluding that the duration of sleep, short or long, is associa- 11. Hartivsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay A, et al. What ted with musculoskeletal pain, especially in the lumbar area16. low back pain is and why we need to pay attention. Lancet. 2018;391(10137):2356-67. 12. Rivas LDA, Valles JLR, Elías DR. Efecto de la arcilla medicinal en quemaduras de The results of this research showed geotherapy as an alternative segundo grado en pacientes del Hospital Nacional Alberto Sabogal Sologuren. Rev in the prevention and treatment of lower back pain, with the Peru Med Intergr. 2016;1(1):25-30. advantage of being painless and non-invasive, acting on the in- 13. Santos EC, Andrade RD, Lopes SGR, Valgas C. Prevalence of musculoskeletal pain in nursing professionals working in orthopedic setting. Rev Dor. 2017;18(4):298-306. 3 dividual’s emotions . Green clay therefore has an effect on os- 14. Sousa PO, Leal SS, Carvalho MEIM. Lombalgia, hábitos posturais e comportamen- teomuscular pain, besides promoting muscle relaxation and hel- tais em acadêmicos de Fisioterapia e Psicologia de uma instituição de ensino superior. 3 Fisioter Bras. 2017;18(5):563-70. ping to reduce tension caused by stress or physical discomfort . 15. Morais LC, Zanuto EAC, Queiroz DC, Araújo MYC, Rocha APR, Codogno JS. As- The results of this research showed that green clay geothe- sociação entre distúrbios do sono e doenças crônicas em pacientes do Sistema Único de Saúde. J Phys Educ. 2017;28:1-9. rapy is an alternative for the prevention and treatment of lo- 16. Chun MY, Choo BJ, Yoo SH, Oh B, Kang JS, Yeon C. Association between sleep wer back pain, acting on the individual’s emotional aspects, duration and musculoskeletal pain. Medicine. 2018;97(50):1-7. promoting muscle relaxation and helping to reduce tension 17. Medeiros GM, Sasso GT, Schlindwein AD. Results of foot reflexotherapy in acute lower back pain of the nursing team: controlled randomized clinical test. BrJP. 2018;1(4):305-9. caused by stress and physical discomfort, with the advantage 18. Cunha MS, Pereira MC. Métodos não farmacológicos para tratamento de dor em of being painless and non-invasive6. Among the non-pharma- idosos. Rev JRG de Estudos Acadêmicos. 2019;2(5):309-17. 19. Artioli DP, Tavares ALF, Bertolini GR. Auriculotherapy: neurophysiology, points to cological therapies for BP relief, geotherapy showed significant choose, indications and results on musculoskeletal pain conditions: a systematic re- results in pain reduction when compared to other studies17-19. view of reviews. BrJP. 2019;2(4):356-61.

216 BrJP. São Paulo, 2020 jul-sep;3(3):217-21 ORIGINAL ARTICLE

Pain intensity and immediate puerperal discomforts Intensidade de dor e desconfortos puerperais imediatos

Thais do Amaral Tomasoni1, Jordana Barbosa Silva2, Thalita Cristina Wolff Bertotti1, Jessica Perez1, Raciele Ivandra Guarda Korelo1, Rubneide Barreto Silva Gallo1

DOI 10.5935/2595-0118.20200047

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: The immediate puer- JUSTIFICATIVA E OBJETIVOS: O puerpério imediato esten- perium extends until the 10th day after delivery, and this period de-se até o 10º dia após o parto, e este período é caracterizado is characterized by the return of the woman’s body to the pre- pelo retorno do corpo da mulher ao estado pré-gravídico. Os -pregnancy state. The aims of the study were to identify pain objetivos deste estudo foram identificar a intensidade da dor e intensity and the major discomforts reported by women in the principais desconfortos relatados pelas mulheres no puerpério immediate puerperium period and to analyze the difference in imediato e analisar a diferença dos desconfortos puerperais de puerperal discomfort according to parity and type of delivery. acordo com a paridade e tipo de parto. METHODS: The participants included 107 women attended MÉTODOS: Participaram deste estudo 107 puérperas assistidas in a public maternity ward. Pain and discomfort were assessed em uma maternidade pública. A dor e os desconfortos foram using the semi-structured physical therapy assessment form and avaliados por meio da ficha de avaliação fisioterapêutica semies- pain intensity was measured using the visual analog scale (VAS). truturada, e a intensidade da dor foi mensurada com a escala ana- Mann-Whitney and Kruskal-Wallis tests were applied to identi- lógica visual. Os testes de Mann-Whitney e Kruskal-Wallis foram fy differences in discomfort according to the type of parity and aplicados para identificar diferenças no desconforto a partir do delivery. tipo de parto e paridade. RESULTS: Colic pain related to breastfeeding with 4.81±2.52 RESULTADOS: Dor em cólica relacionada à amamentação de intensity was reported by 55.14% of mothers in the puerpe- intensidade 4,81±2,52 foi referida por 55,14% das puérperas, rium, perineal pain with 4,06±2,09 intensity by 30.84%, low dor perineal de intensidade 4,06±2,09 foi referida por 30,84%, back pain with 4.38±2.09 intensity by 28.97%, breast pain with lombalgia de intensidade 4,38±2,09 foi referida por 28,97%, dor 4.76±2.63 intensity by 23.36% and cesarean related pain with nas mamas de intensidade 4,76±2,63 foi referida por 23,36% 5.21±2.01 intensity was reported by 17.75% of mothers. No e dor relacionada a cesariana de intensidade 5,21±2,01 por significant differences in pain intensity were found according to 17,75%. Não foram encontradas diferenças significativas na in- parity. However, significant differences were found for perineal tensidade da dor de acordo com a paridade, porém foram encon- pain intensity and cesarean section. tradas diferenças significativas para intensidade da dor perineal e CONCLUSION: Pain intensity evaluated by the visual analog incisão da cesariana. scale was classified as moderate or light. CONCLUSÃO: A intensidade da dor avaliada pela escala analó- Keywords: Labor pain, Postpartum period, Women’s health. gica visual foi classificada como moderada ou leve. Descritores: Dor do parto, Período pós-parto, Saúde da mulher.

INTRODUCTION Thais do Amaral Tomasoni – https://orcid.org/0000-0002-9296-0994; Jordana Barbosa da Silva – https://orcid.org/0000-0001-9867-3788; Thalita Cristina Wolff Bertotti – https://orcid.org/0000-0003-0123-6413; The postpartum period is called puerperium and can be divided Jessica Perez – https://orcid.org/0000-0001-7643-8920; st th th th Raciele Ivandra Guarda Korelo – https://orcid.org/0000-0002-6754-098X; into: immediate – from 1 to 10 day, late – from 10 to 45 Rubneide Barreto Silva Gallo – https://orcid.org/0000-0001-9953-0260. day and remote – after the 45th day. In this phase, local and 1. Universidade Federal do Paraná, Departamento de Prevenção e Reabilitação em Fisiote- systemic changes return the women’s body to its pre-gravidic rapia, Curitiba, PR, Brasil. state1. During the immediate puerperium, some inherent 2. Universidade Federal de São Carlos, Departamento de Fisioterapia, São Carlos, SP, Brasil. discomforts related to the birth process are present. Pain is Submitted on December 11, 2019. the most frequent symptom reported by mothers during this Accepted for publication on May 15, 2020. period and can cause limitations on movement, walking and Conflict of interests: none – Sponsoring sources: none changing of posture in bed2, beyond complicating the bond Correspondence to: between mother and newborn (NB)3. Rubneide Barreto Silva Gallo Av. Coronel Francisco Heráclito dos Santos, 210. Due to its multifactorial and complex phenomenon, treatment 81531-980, Curitiba, PR, Brasil. of pain demands multi professional approach, aiming at better E-mail: [email protected] quality of life for women4. Comprehending and evaluating pain © Sociedade Brasileira para o Estudo da Dor facilitates its profiling, but also brings the physiotherapist clo- 217 BrJP. São Paulo, 2020 jul-sep;3(3):217-21 Tomasoni TA, Silva JB, Bertotti TC, Perez J, Korelo RI and Gallo RB ser to the patient, making the professional more aware of the 10 the worst imaginable pain. The intensity of pain reported by meaning of pain and its repercussions. However, most health the participants was classified in light (1-3), moderate (4-6) and professional activities during the puerperium are directed to the severe (7-10). NB and are scarce when it comes to the self-care and discomfort The study was approved by the Human Research Ethics Com- reduction for mothers5. mittee from the Hospital das Clínicas, according to number The Ministry of Health advocates a qualified and humanized 1.674.698, CAAE 56163616.8.0000.0096. attention to women during the puerperium6. Nonetheless, professional action based on the biomedical model and the igno- Statistical analysis rance of complaints and real complications during puerperium The data were processed by the SPSS software, version 21.0. The contribute to the non-conformity between the indicated assis- numeric variables are presented in mean±standard deviation. tance model and the one found in the health institutions7. On The descriptive variables were analysed by frequency (n) and per- the other hand, there is a growing demand for physiotherapeutic centage (%). To perform the difference analysis, data normality care in Women’s Health, implying an adequate assistance foun- was analyzed by the Kolmogorov-Smirnov test. To analyze the ded in the whole puerperium-gravidic cycle. Its important that difference in pain intensity according to parity, the Mann-Whit- the public maternities’ physiotherapists understand the profile ney test was applied. Participants were allocated to two groups: of the mothers in the puerperium in order to obtain informa- 1) primiparous; and 2) multiparous. For the difference analysis tion that addresses the better approach of the preventive and of the type of delivery the Kruskal-Wallis and the Mann-Whit- physiotherapeutic evaluation and intervention1. In addition, the ney post-hoc tests were applied. The mothers were allocated in role of the hysiotherapist is considered to assist in improving of four different groups, according to the type of delivery: a) with assistance directed to puerperal women8, from promotion and intervention (episiotomy and/or forceps); b) grade 1 or 2 lacera- prevention to health intervention9. tion; c) cesarean section; d) normal. The significance value was Therefore, the primary objective of this study was to evaluate the established at p<0.05. intensity of pain and the main discomforts reported by women in the immediate puerperium. The secondary objective was to RESULTS evaluate the difference of the puerperal discomforts according to the parity and type of delivery. The participants had an mean age of 26±6.44 years old, in its majority multiparous (58.9%), had white skin (60.7%), comple- METHODS te high school (54.2%), paid occupation (56.1%), stable union (43.9%) and the majority had an escort accompanying them du- Cross sectional study with 107 women during the immediate ring all the labor and immediate postpartum (97.2%). puerperium, through the first 17h from birth, in the period of Mean gestational age in weeks was 39±1.16 with a 95% confi- August 2016 and May 2017. dence interval (95%CI) from 39 to 40 weeks, with mean prena- Mothers with a usual level of risk which were being attended at tal appointments of 9±3.0 and labor time of 486±334.7 minu- an accommodation in a public maternity ward and with no cog- tes; 95%CI: 3335-638.2). Most puerperal women had vaginal nitive problems were included. The mothers agreed in participa- delivery (73.7%); 6.5% had vaginal delivery with episiotomy ting in the study after reading and signing the Free and Informed and/or forceps and one participant had grade 3 laceration after Consent Term (FICT). According to the 466/2012 Resolution delivery (0.9%). The mean weight of the NBs was 3.19±0.4 kg of the National Health Council. (95%CI2.99-3.38). The Apgar index was higher than seven in The following participants were excluded: those that asked to be the 1st minute (77.6%) and in the 5th minute (82.2) of NBs. suspended from the research, that didn’t complete the evaluation Puerperal women reported discomfort related to breastfeeding form or that had missing information in their medical records and intestine, as well as circulatory, urogynecological and mus- and those that had puerperal complications. culoskeletal discomfort (Table 1). One of the tools used in this research was a semi-structured The average of all discomforts reported by the puerperal mothers questionnaire developed by the researchers in order to profile the and evaluated by the VAS was classified as moderate. In the in- sample. This questionnaire is used in physiotherapeutic atten- dividual analysis of the VAS, most participants classified cesa- dance and contains questions about the personal and obstetric rean pain, breast pain and back pain as moderate. The intensity data of the participants. This tool also contains questions related of perineal pain and colic pain during breastfeeding was mostly to urinary and intestinal complaints during pregnancy. Next, the classified as light. Pain considered severe was: colic pain during participants were questioned about the presence of puerperal breastfeeding 18 (16.8%) cesarean section incision, perineal and discomforts in the upper limbs (UL), lower limbs (LL), torso, back pain, 5 (4.7%) and breast pain 4 (3.7%) (Table 2). cesarean incision and perineal area, apart from the classification Table 3 presents the average and standard deviation values ba- of discomforts related to the urogynecological, intestinal and sed on the classification of discomfort intensity by the puerperal circulatory symptoms. After confirming the presence of pain, mothers and the difference result of pain intensity according to the participant was to classify the intensity of pain in the visual the parity and type of delivery. The pain intensity was superior in analog scale (VAS)10, which consists in a 10cm ruler, numbered women that went through cesarean delivery. In ascending order, from zero to 10, in which zero is the total absence of pain and the main discomforts found in this study were: cesarean pain, 218 Pain intensity and immediate puerperal discomforts BrJP. São Paulo, 2020 jul-sep;3(3):217-21

Table 1. Immediate puerperal discomfort reported by puerperal Table 3. Intensity of pain during the immediate puerperium mothers Variables Mean±SD p-value* p-value* Discomfort when breastfeeding n (%) A,C,E Breast pain 25 (23.3) Cesarean incision 5.21±2 0.38 0.00 Breast trauma 9 (8.3) Perineal 4.06±2.09 0.99 0.00 B,D,F Colic during breastfeeding 58 (55.1) Breasts 4.76±2.63 0.73 0.59 Intestinal discomfort Diarrhea 5 (4.7) Colics during breastfeeding 4.81±2.52 0.21 0.86 Constipation 8 (7.5) Back pain 4.38±2.09 0.06 0.09 Flatulence 16 (15) # Fecal incontinence 6 (5.6) p* = p<0.05; Mann-Whitney test according to parity; p = p<0.05; Kruskal-Wal- lis test according to type of delivery; Post-hoc (type of delivery) = Ap<0.002 in Constipation and flatulence 9 (8.4) relation to group A (0) and C (3.80); Bp=0. 02 in relation to group A (2) and C (0); Circulatory discomfort Cp<0.000 in relation to group B (=0) and C (3.80); Dp<0.000 in relation to group B E F Varices 9 (8.4) (1.97) and C (0); p<0,000 in relation to group C (3.80) and D (VAS=0); p<0.000 in relation to group C (=0) and D (1.13). Hemorrhoid 3 (2.8) Edema 18 (16.8) Varicose veins and edema 4 (3.7) Urological discomfort DISCUSSION SUI in pregnancy 31 (39.2) SUI in the puerperium 3 (3.1) During the immediate puerperium, women go through physical, Musculoskeletal discomfort psychological and social alterations. Still in the hospital puerpe- Carpal tunnel syndrome 2 (1.8) Back pain 31 (28.9) ral women present complaints related to the puerperium, like Weakness of UL 7 (6.5) pain, insecurity and fear. Post-partum complications can affect SUI = stress urinary incontinence; UL = upper limbs. quality of life and state of health of the puerperal mothers and the NB11. Therefore, during the puerperium, the multidisciplinary team must be attentive to the elaboration of a care plan colic pain during breastfeeding, breast pain, back pain and pe- that offers the necessary support to women, regarding self-care, rineal pain. No significant differences were found for the inten- transformations related to post-partum and NB care12. sity of pain reported by women according to the parity between Pain was classified as moderate for all of the mentioned discom- primiparae and multiparae. Also, no significant differences were forts after 40h from birth. It’s important to notice that the puer- found when women were compared according to the type of peral mothers were receiving analgesics each 6h, which is part of delivery for the intensity of pain reported in the breasts, colic the hospital routine, and their usage did not seem to resolve the during breastfeeding and back pain. However, significant diffe- cases of pain. rences were found for pain intensity in the cesarean section and Pain can be limiting for women, since it can interfere in mobility perineal pain in women with cesarean and vaginal delivery with and performance of daily activities13. In this study, the puerperal episiotomy and/or forceps intervention, vaginal delivery with la- mothers reported discomforts related to breastfeeding and asso- ceration, and normal delivery. ciated to the intestinal, circulatory, urological and musculoskele- It’s worth mentioning that puerperal mothers received routine tal systems. analgesic drugs every 6 hours during the period of hospitaliza- In accordance to these data, the study14 also found high prevalen- tion, such as paracetamol and dipyrone. ce of discomfort in women during the immediate puerperium.

Table 2. Prevalence of discomfort in the immediate puerperium reported by study participants Pain intensity VAS Cesarean Perineal Breast Colic during breastfeeding Back pain n (%) n (%) n (%) n (%) n (%) 0 88 (82.2) 74 (69.2) 82 (76.6) 48 (44.9) 76 (71) Mild pain 1 1 (0.9) 3 (2.8) 1 (0.9) 2 (1.9) 1 (0.9) 2 1 (0.9) 4 (3.7) 4 (3.7) 8 (7.5) 5 (4.7) 3 1 (0.9) 8 (7.5) 5 (4.7) 14 (13.1) 6 (5.6) Moderate pain 4 2 (1.9) 5 (4.7) 2 (1.9) 9 (8.4) 5 (4.7) 5 8 (7.5) 3 (2.8) 6 (5.6) 6 (5.6) 7 (6.5) 6 1 (0.9) 3 (2.8) 3 (2.8) 1 (0.9) 2 (1.9) Severe pain 7 2 (1.9) 2 (1.9) 0 4 (3.7) 2 (1.9) 8 2 (1.9) 3 (2.8) 0 9 (8.4) 2 (1.9) 9 1 (0.9) 0 1 (0.9) 3 (2.8) 0 10 0 0 3 (2.8) 2 (1.9) 1 (0.9) VAS = visual analog scale.

219 BrJP. São Paulo, 2020 jul-sep;3(3):217-21 Tomasoni TA, Silva JB, Bertotti TC, Perez J, Korelo RI and Gallo RB

Approximately 73% of patients reported some discomfort, being low-up and guidance of health professionals in the pregnancy the cesarean the type of delivery most associated with the pre- and/or puerperal period. The multi professional team should sence of discomforts. Another Brazilian study15 with puerperal attend the puerperal women based on their social, cultural and mothers considered pain as a the maternal complication most ethical context. Difficulties related to breastfeeding can lead to frequent in the puerperium, with similar numbers, indepen- several consequences, such as early weaning, which puts the dently of the types of delivery. However, cesarean delivery was baby’s health at risk23,24. associated with a higher risk of maternal complications and fe- According to the results of this study, back pain was one of the minine sexual dysfunction and presented a negative correlation main discomforts reported by puerperal women. A similar result to the incentive to breastfeeding practices. was found in the study25, which highlighted back pain as the In this study, the greatest intensity of pain was attributed to the main discomfort, being classified with moderate intensity. This pain in the cesarean incision, with confidence interval varying discomfort can lead to motor disability and can be reported by from 4.23 to 6.18. No significant differences between pain in- women who have recently given birth regardless of the type of tensity in women regarding type of delivery were found. delivery14. However, the results of the studies2,7 showed a pre- Nonetheless, the pain intensity on the cesarean incision was su- valence of discomfort and functional limitations during daily perior to the related by women who underwent normal delivery activities in puerperal women who underwent cesarean delivery. or had some sort of complication and/or laceration. However, it is worth highlighting that changes in the spine re- It is known that cesarean rates have increased in many countries, sulting from physical changes in pregnancy may contribute to including Brazil, contrary to the World Health Organization the presence of marked pain in the lumbar region13. Therefore, (WHO) guidelines for vaginal delivery16,17. Pain after a cesarean individual physical evaluation by health professionals may direct section is closely linked to tissue injury due to inflammatory reac- the resolution of the complaint earlier14. tions resulting from a traumatic process that can produce pain1. Although parity is an influential variable in postpartum reco- In addition, the abdominal scar resulting from the surgery may very and perception of women’s pain26, the results of this study impair the action of drainage by the lymphatic system, and restrict do not support this hypothesis, given the absence of significant movement due to the presence of pain and/or fear, increasing the differences in the analysis of pain intensity reported by primi- period of bed stay and favoring the emergence of edemas of the parous and multiparous women. Thus, the results of this study SL14. Similar results were found in the study2, which measured emphasize the importance of humanized attention of women pain in the cesarean section and found a range of 1 to 9 during with or without previous experience with childbirth and pos- rest, with a mean pain lower than that found in this study <5.21. tpartum period. Concomitant to this finding, the results of the However, 75% of study participants reported pain located around study7 with women during the immediate puerperium did not the cesarean section incision. Similar to these findings, the study14 indicate an association between parity and functional limita- found a higher prevalence of abdominal pain, cervicalgia and ede- tions. However, it is worth noting that previous experiences re- ma in women who underwent cesarean section. lated to childbirth can be modulating for the threshold of pain, Among the discomforts reported by the puerperal mothers, and one should consider the subjectivity and individuality of the perineal pain presented a lower mean, but was similar to pain experience, since it is based on biological, psychological the result of Brazilian studies in which the mean perineal pain and environmental responses26. was 4.818 and 4.219. It is also noteworthy that in this study less The analysis of data of the present study calls attention to the than 50% of the sample presented perineal pain and of these need of promotion of activities for the puerperal women’s health, only 3.6% had episiotomy and 0.9% third degree laceration. since these are scarce and mostly cover only the NB care and not In the present study, the highest frequency of complaints was the advising for women’s selfcare5. Most postpartum discomfort associated with colic pain during breastfeeding, with the discom- can be avoided or reduced by early postpartum interventions27. fort being the second highest pain intensity. This symptom is Even complaints of pain can be reduced after non-pharmaco- common during the postpartum period20, regardless of the route logical physiotherapeutic intervention, leading to 100% adhe- of delivery21 and occurs because during breastfeeding there is re- rence to treatment13. Thus, the importance of interdisciplinary lease of oxytocin, the hormone responsible for milk ejection and health practices and the promotion of maternal and child care14 for promoting uterine contractions20. The prevalence of colic du- is highlighted. Information and resolution activities during the ring breastfeeding was 40% in study participants12 undergoing immediate puerperium are well evaluated by women and could cesarean section. In the study13, 15% of women in the immedia- be implemented in the routine maternity services9. te puerperium presented this symptom. The physiotherapist is a qualified professional who composes Considering the reports of breast pain, 66% of the participants multi professional teams and can help in reducing puerperal of this study presented breast fissures and reported moderate discomfort through the application of specific physiotherapeu- to severe pain in the area. The percentage of women with such tic and non-pharmacological resources13, such as kinesiotherapy, complaint was higher than the data presented in a study with cryotherapy28 and electrotherapy29,30, which make up the physio- puerperal women 2 and 4 months after delivery22. However, therapeutic practices aimed at reducing discomfort. In addition, similarly to the present study, the intensity of pain reported by the use of these resources can contribute to reduce women’s hos- puerperal women ranged from moderate to severe to 66.7% of pitalization time, as well as reduce the need for drugs methods participants22. This finding may be related to the deficit of fol- of analgesia3. 220 Pain intensity and immediate puerperal discomforts BrJP. São Paulo, 2020 jul-sep;3(3):217-21

CONCLUSION 2005;10(2):123-8. 11. Cheng CY, Li Q. Integrative review of research on general health status and prevalence of common physical health conditions of women after childbirth. Womens Health The main discomforts reported by puerperal women were related to Issues. 2008;18(4):267-80. 12. Mazzo MH, Brito RS, Feitosa MM, Lima MS, Silva EC. Percepção das puérperas breastfeeding, in addition to intestinal, circulatory, urological and sobre seu período pós-parto. Investig Enferm. 2018;20(2):1-9. musculoskeletal discomforts. The pain intensity in the cesarean inci- 13. Burti JS, Cruz JP, Silva AC, Moreira IL. Assistência ao puerpério imediato: o papel da sion, colic during breastfeeding, breasts, lumbar spine and perineum fisioterapia. Rev Fac Ciênc Méd Sorocaba. 2016;18(4):193-8. 14. Pereira TR, Montesano FT, Ferreira PD, Minozzi AS, Beleza AC. Existe associação en- was classified as moderate. However, these were classified as severe tre os desconfortos no puerpério imediato e a via de parto? Um estudo observacional. by some puerperal mothers, specially the pain of colic during breast- ABCS Health Sci. 2017;42(2):80-4. 15. Prado DS, Mendes RB, Gurgel RQ, Barreto IDC, Cipolotti R, Gurgel RQ. The in- feeding. There was no difference in the intensity of pain by parity. fluence of mode of delivery on neonatal and maternal short and long-term outcomes. There were significant differences in the intensity of pain with cesa- Rev Saude Publica. 2018;52:95. rean section and vaginal delivery with episiotomy and/or forceps, 16. Chen I, Opiyo N, Tavender E, Mortazhejri S, Rader T, Petkovic J, et al. Non‐clinical interventions for reducing unnecessary caesarean section. Cochrane Database Syst vaginal delivery with laceration and normal delivery. Rev. 2018;28(9):CD005528. 17. Souza JP, Betran AP, Dumont A, de Mucio B, Gibbs Pickens CM, Deneux-Tharaux C, et al. A global reference for caesarean section rates (C‐Model): a multicountry REFERENCES cross‐sectional study. BJOG. 2016;123(3):427-36. 18. Francisco AA, Oliveira SM, Santos JO, Silva FM. Avaliação e tratamento da dor peri- 1. Rett MT, Bernardes NO, Santos AM, Oliveira MR, Andrade SC. Atendimento de neal no pós-parto vaginal. Acta Paul Enferm. 2011;24(1):94-100. puérperas pela fisioterapia em uma maternidade pública humanizada. Fisioter Pesq. 19. Pitangui AC, Sousa L, Ferreira CH, Gomes FA, Nakano AM. Mensuração e caracte- 2008;15(4):361-6. rísticas da dor perineal em primíparas submetidas à episiotomia. Acta Paul Enferm. 2. Sousa L, Pitangui AC, Gomes FA, Nakano AM, Ferreira CH, Mensuração e caracterís- 2009;22(1):77-82. ticas de dor após cesárea e sua relação com limitação de atividades. Acta Paul Enferm. 20. Lelis BDB, Pereira RC, Silva LFI, Leite AM, Dusso MIS, Bernardes NB. Acolhimento 2009;22(6):741-7. puerperal no contexto atribuído às primíparas. Rev Mult Psic. 2019;45(13):287-301. 3. Santana LS, Gallo RB, Marcolin AC, Ferreira CH, Quintana SM. Utiliza- 21. Wen L, Hilton G, Carvalho B. The impact of breastfeeding on postpartum pain after ção dos recursos fisioterapêuticos no puerpério: revisão da literatura. Femina. vaginal and cesarean delivery. J Clin Anesth. 2015;27(1):33-8. 2011;39(5):245-50. 22. Benedett A, Silva IA, Ferraz L, Oliveira P, Fragoso E, Ourique J. A dor e desconforto 4. Ferreira CH, Beleza AC. Abordagem fisioterapêutica na dor pós-operatória: a eletroes- na prática do aleitamento materno. Cogitare Enferm. 2014;19(1):136-40. timulação nervosa transcutânea (ENT). Rev Col Bras Cir. 2007;34(2):127-30. 23. Strapasson MR, Nedel MNB. Puerpério imediato: desvendando o significado da ma- 5. Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção ternidade. Rev Gaúcha Enferm. 2010;31(3):521-8. Básica. Saúde da Criança: Nutrição Infantil, aleitamento materno e alimentação com- 24. Souza MJN, Barnabé AS, Oliveira RS, Ferraz RRN. A importância da orientação à plementar. Brasília: Caderno de Atenção Básica; 2009. gestante sobre amamentação: fator para diminuição dos processos dolorosos mamá- 6. Brasil. Ministério da Saúde, Secretaria de Atenção à Saúde, Departamento de Ações rios. ConScientiae Saúde. 2009;8(2):245-9. Programáticas Estratégicas. Ministério da Saúde; Brasília: 2005. Área Técnica de Saúde 25. Morari-Cassol EG, Campos Júnior D, Haeffner LSB. Desconforto músculo-esquelé- da Mulher. Pré-natal e Puerpério: atenção qualificada e humanizada – manual técnico/ tico no pós-parto e amamentação. Fisioter Brasil. 2017;9(1):9-16. Ministério da Saúde, Secretaria de Atenção à Saúde, Departamento de Ações Progra- 26. Mannion CA, Vinturache AE, McDonald SW, Tough SC. The influence of back pain máticas Estratégicas. 163p. color – (Série A. Normas e Manuais Técnicos) – (Série and urinary incontinence on daily tasks of mothers at 12 months postpartum. PLoS Direitos Sexuais e Direitos Reprodutivos – Caderno n° 5). One. 2015;10(6):e0129615. 7. Pereira TRC, Souza FG, Beleza ACS. Implications of pain in functional activities in 27. Rizvi RM, Khan ZS, Khan Z. Diagnosis and management of postpartum urinary immediate postpartum period according to the mode of delivery and parity: an obser- retention. Int J Gynecol Obstet. 2005;91(1):71-2. vational study. Braz J Phys Ther. 2017;21(1):37-43. 28. Francisco AA, de Oliveira SM, Leventhal LC, de Bosco CS. [Cryotherapy after child- 8. Odunaiya NA, Ilesanmi T, Fawole AO, Oguntibeju OO. Attitude and practices of birth: the length of application and changes in perineal temperature]. Rev Esc Enferm obstetricians and gynecologists towards involvement of physiotherapists in manage- USP. 2013;47(3):555-61. Portuguese. ment of obstetric and gynecologic conditions. Int J Womens Health. 2013;5:109-14. 29. Kayman-Kose S, Arioz DT, Toktas H, Koken G, Kanat-Pektas M, Kose M. et al. 9. Silva JB, Doi GE, Silva LC, Feltrin MI, Zotz TG, Korelo RI, Gallo RB. Satisfação Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal de- de puérperas após intervenção fisioterapêutica em educação em saúde. Saúde Pesq. livery and cesarean section. J Matern Fetal Neonatal Med. 2014;27(15):1572-5. 2019;12(1):141-50. 30. Pitangui AC, Araújo RC, Bezerra MJ, Ribeiro CO, Nakano AM. Low and high-fre- 10. Kahl C, Cleland JA. Visual analogue scale, numeric pain rating scale and the Mc- quency TENS in post-episiotomy pain relief: a randomized, double-blind clinical Gill pain Questionnaire: an overview of psychometric properties. Phys Ther Rev. trial. Braz J Phys Ther. 2014;18(1):72-8.

221 BrJP. São Paulo, 2020 jul-sep;3(3):222-7 ORIGINAL ARTICLE

Relationship between symptoms and imagenological signs of degenerative temporomandibular joint disorders using the Research Diagnostic Criteria for Temporomandibular Disorders and cone-beam computed tomography Relação entre sintomas e sinais imagenológicos das disfunções degenerativas da articulação temporomandibular com o Research Diagnostic Criteria for Temporomandibular Disorders e a tomografia computadorizada de feixe cônico

Bruno Moreira da-Silva1, Rafael de Almeida Spinelli Pinto2, Letícia Ladeira Bonato2, Arnaud Alves Bezerra-Júnior2, Eduardo Grossmann3, Luciano Ambrósio Ferreira1

DOI 10.5935/2595-0118.20200045

ABSTRACT joint changes using the Research Diagnostic Criteria for Tem- poromandibular Disorders questionnaire. The presence of pain BAKGROUND AND OBJECTIVES: Arthralgia is a common was considered during lateral palpation; intra-articular palpa- complaint among patients with temporomandibular osteode- tion; excursive movements; and active mouth opening. generation, however, for the accurate diagnosis of osteodegenera- RESULTS: Among the purely clinical diagnoses, only 10.5% tion, it is suggested the adoption of imaging tests associated with were conclusive, classifying patients as suffering from osteoar- standardized clinical diagnosis protocols. The objective of this thritis/osteoarthrosis. Painful joint symptoms were found in all study was to evaluate patients with degenerative changes in the groups, with no statistically significant difference. Similarly, the temporomandibular joint previously visualized by cone beam presence of degenerative disorders, including flattening, osteo- computed tomography, relating these changes with the clinical phytes, sclerosis, and erosion were found in similar proportions diagnoses and symptoms of temporomandibular disorders, in or- in all diagnosis groups. der to conclude which of the degenerative changes develop more CONCLUSION: 89.5% of the degenerative changes were clini- painful symptomatology. cally underdiagnosed. There was a positive association between METHODS : A cross-sectional observational descriptive study. the presence of symptoms and the number of correct clinical Thirty-eight patients who had previously done the cone beam diagnoses of osteoarthritis/osteoarthrosis obtained with the Re- computed tomography exam were evaluated. Subjects were search Diagnostic Criteria for Temporomandibular Disorders. grouped according to clinical diagnosis of temporomandibular Keywords: Arthralgia, Cone-beam computed tomography, Os- teoarthritis, Temporomandibular joint disorders.

RESUMO

JUSTIFICATIVA E OBJETIVOS: Entre os pacientes com os- Bruno Moreira da-Silva – http://orcid.org/0000-0003-0278-4833; Rafael de Almeida Spinelli Pinto – http://orcid.org/0000-0002-3503-6025; teodegeneração cortical temporomandibular, a artralgia é uma Leticia Ladeira Bonato – http://orcid.org/0000-0002-2171-1181; queixa comum, entretanto, para o diagnóstico preciso de osteo- Arnaud Alves Bezerra-Júnior – https://orcid.org/0000-0001-6760-2522; Eduardo Grossmann – http://orcid.org/0000-0002-1238-1707; degeneração sugere-se a adoção de exames de imagem associados Luciano Ambrósio Ferreira – http://orcid.org/0000-0002-7965-6787. a protocolos de diagnóstico clínico padronizados. O objetivo 1. Universidade Federal de Juiz de Fora, Faculdade de Odontologia, Juiz de Fora, MG, Brasil. deste estudo foi avaliar pacientes com alterações degenerativas 2. Centro Universitário Estácio Juiz de Fora, Departamento de Odontologia, Juiz de Fora, da articulação temporomandibular previamente visualizados por MG, Brasil 3. Universidade Federal do Rio Grande do Sul, Departamento de Morfologia, Porto Alegre, tomografia computadorizada de feixe cônico, relacionando essas RS, Brasil. alterações com os diagnósticos e sintomas clínicos da disfunção

Submitted on December 20, 2019. temporomandibular, a fim de concluir quais das alterações dege- Accepted for publication on March 17, 2020. nerativas causam mais dor. Conflict of interests: none – Sponsoring sources: none. MÉTODOS: Trata-se de um estudo observacional descritivo Correspondence to: transversal. Foram avaliados 38 pacientes que já haviam realizado a Letícia Ladeira Bonato Rua José Lourenço Kelmer, s/n - São Pedro tomografia computadorizada de feixe cônico. Os indivíduos foram 36036 Juiz de Fora, MG, Brasil. agrupados de acordo com o diagnóstico clínico de alterações na ar- E-mail: [email protected] ticulação temporomandibular, utilizando o questionário Research © Sociedade Brasileira para o Estudo da Dor Diagnostic Criteria for Temporomandibular Disorders. A presença de 222 Relationship between symptoms and imagenological signs of degenerative BrJP. São Paulo, 2020 jul-sep;3(3):222-7 temporomandibular joint disorders using the Research Diagnostic Criteria for Temporomandibular Disorders and cone-beam computed tomography dor foi considerada durante: palpação lateral; palpação intra-arti- disorders, enabling the visualization of changes even in the early cular; movimentos excursivos; e abertura ativa da boca. stages of the disease2. While the first is able to show inflamma- RESULTADOS: Entre os diagnósticos puramente clínicos, ape- tion activity by T2 ponderation, the latter is considered the gold nas 10,5% foram conclusivos, classificando os pacientes como standard and, represented by cone beam computed tomography portadores de osteoartrite/osteoartrose. Sintomas articulares do- (CBCT), is a useful imaging modality for dentistry, with high lorosos foram encontrados em todos os grupos, sem diferença dimensional accuracy for evaluation of facial structures, includ- estatisticamente significante. Da mesma forma, a presença de ing TMJ12. With this exam it’s possible to observe the presence of distúrbios degenerativos, incluindo achatamento, osteófitos, es- flattening, sclerosis, osteophytes, erosion, resorption of the man- clerose e erosão, foi encontrada em proporções semelhantes em dibular condyle and/or fossa, as well as decreased joint space13. todos os grupos de diagnóstico. It’s noted that, although for intra-articular conditions there CONCLUSÃO: 89,5% das alterações degenerativas foram cli- is a need to use images for the determination of pathological nicamente subdiagnosticadas. Houve associação positiva entre a changes, the authors of the DC/TMD themselves emphasize presença de sintomas e o número de diagnósticos clínicos corre- that imaging exams should not be used routinely11, emphasizing tos de osteoartrite/osteoartrose obtidos com o Research Diagnos- the importance of clinical examination. Professionals should be tic Criteria for Temporomandibular Disorders. alert for the existence of signs and symptoms related to inflam- Descritores: Artralgia, Osteoartrite, Tomografia computadori- matory processes (even subclinical), including the presence of ear zada de feixe cônico, Transtornos da articulação temporoman- and joint pain, joint stiffness, clicking, crackling, and limitation dibular. of mandibular movement14, in an attempt to make the diagnosis ever more accurate, even without the use of additional tests. INTRODUCTION This study aims to evaluate patients with degenerative changes in the TMJ previously visualized through CBCT, relating such The temporomandibular joint (TMJ) is a complex structure that changes to the quality and quantity of clinical diagnoses and ar- can be affected by degenerative processes1, with osteoarthritis be- throgenic symptoms of TMD. ing one of the most prevalent arthrogenic manifestations in this joint2. The degenerative process generally is manifested in a de- METHODS bilitating chronic form, with degradation of articular cartilage and subchondral bone changes evolving into synovial fibrosis3,4. This is a cross-sectional observational descriptive study. The sam- It is believed that despite the multifactorial etiology, such changes ple was selected using the analysis of CBCT previously obtained are associated with a dysfunctional remodeling5 due to dimin- at the radiology department of the School of Dentistry. Indi- ished adaptive capacity and/or functional overload of this joint6,7. viduals were selected from both genders, with ages from 18 to 75 Changes in the protein of the beta-type transforming growth fac- years, and who had imaging signs of degeneration in at least one tor (TGF-β) have fundamental importance in the development of TMJ. Patients who had already undergone treatment for TMD this pathology, since it is responsible for stimulating production of were excluded, as well as those with craniofacial trauma history proteoglycans and type II collagen in the TMJ3,5,8. who had already done some surgery, and patients with other pa- To date, there are few instruments that can determine the pres- thologies involving this joint region. ence, severity, and progression of these degenerative processes in The study methodology was divided into three levels: the TMJ, with treatment and diagnosis being based on clinical 1. Assess the presence of degenerative TMJ disorders through exams and imaging9. Depending on the diagnostic method used, analysis of CBCT. on its specificity and sensitivity, the prevalence of these disorders For the examination of each TMJ, the representative coronal can affect from 1 to 84% of the general population2. section (most central region) of the mandibular condyle was Currently, the Research Diagnostic Criteria for Temporoman- selected, obtained using the TMJ window of the iCat Vision dibular Disorders (RDC/TMD) is the most widely used instru- tomographic image handling software (Imaging Sciences Inter- ment, especially in research. Although it is possible to perform the national, Hatfield, Pennsylvania, USA). From this coronal sec- diagnosis of osteoarthritis/osteoarthrosis with this instrument, tion sequential parasagittal sections were generated, where the the use of tomograms is recommended as the gold standard for articular bone changes were evaluated. the diagnosis of such degenerative processes10. Imaging tests are The bone surfaces of the mandibular condyle and articular emi- necessary for the diagnosis of degenerative TMJ process, but this nence of each TMJ were classified according to the methodology does not mean that the disease is active or needs treatment10,11. described by the study15, according to the presence of: healthi- In 2014, an evolution of the old RDC/TMD - the “Diagnostic ness (no change); flattening (loss of rounded contour of sur- Criteria for Temporomandibular Disorders” (DC/TMD - was faces); erosion (loss of continuity in cortical bone); osteophytes published in English, created with clinical and research objec- (exophytic formations growing from surfaces); and sclerosis (any tives. This new tool has a sensitivity of 0.55 and specificity of increase in cortical thickness in load-bearing areas). Each possi- 0.61 related to the diagnosis of degenerative changes, which sus- ble change could appear alone or in combination, in at least two tains the need for the use of images11. sequential parasagittal sections. This assessment was performed Thus, magnetic resonance imaging (MRI) and computed tomog- by a radiologist with experience in TMJ CBCT images, without raphy (CT) are still recommended to aid in the diagnosis of these knowledge of the patient’s clinical data. 223 BrJP. São Paulo, 2020 jul-sep;3(3):222-7 Silva BM, Pinto RA, Bonato LL, Bezerra-Júnior AA, Grossmann E and Ferreira LA

To perform the CBCT, the i-Cat Next Generation system was using the Spearman correlation test. A significance level of 5% used, operating at 120 kV and 3-8mA, with the following im- (p≤0.05) and a 95% confidence interval were adopted. The cal- age acquisition protocol specific to the TMJ region: exposure time culations were performed using SPSS 16.0 for Windows (IBM, 26.9 s, FOV of 8 cm, and voxel (slice thickness) of 0.25mm. All Chicago, Illinois, USA). images were obtained in the open and closed mouth positions. 2. Clinical diagnosis of TMD RESULTS Once selected, the individuals who had degenerative changes observed in the CBCT examination were asked to return to the From the analysis of CBTC, it was possible to select 38 indi- School of Dentistry to participate in the study and a subsequent viduals with degenerative changes in at least one of the TMJs, clinical examination of the TMJ. being 34 females and four males. The mean age of the sample The RDC/TMD - Axis 10,16I enabled verification of whether the was 48.8±9.2 years. patients had some type of TMD, as well as classification accord- Clinically, according to the classification proposed by the RDC/ ing to their type: 1) muscle disorders (Group I); 2) articular disc TMD, it was possible to divide the sample into three groups ac- position changes (Group II); and 3) painful and degenerative con- cording to diagnosis obtained, for comparison purposes: patients ditions of the TMJ (Group III). The instrument was administered without TMD; patients without a group III clinic diagnosis; and to all patients by a single trained and calibrated examiner. This di- patients with a group III clinic diagnosis (Table 1). agnostic method is considered the gold standard for diagnosis in According to the symptoms presented, in the group of individu- TMD research10,16. RDC/TMD does not include imaging exams als clinically diagnosed without TMD, 28.5% had pain during but suggests performing CT or MRI scans based on information mouth opening, as well as pain on intra-auricular palpation. In obtained10,11,15. participants without a group III diagnosis, the main symptom 3. Assessment of the number of painful symptoms present in found was joint pain during excursive movements, 46.6% were each joint symptomatic during lateral palpation and on intra-auricular pal- Through the clinical examination of the RDC/TMD, the joint pation. In those with degenerative changes observed both via im- symptoms present were assessed, considering a) pain on lateral aging as well as the RDC/TMD, 100% had pain on lateral pal- palpation; b) pain on intra-auricular palpation; c) pain during pation (Table 2). Using the Spearman correlation test, positive excursive movements; and d) pain during active mouth opening. correlation was observed between the presence of symptoms and This study was approved by the institution’s Research Ethics the number of clinical diagnosis (r=0.5585) with a statistically Committee, CAAE: 308.39714.4.0000.5147 and registration significant p-value (p=0.0003), suggesting that as more symp- number. 708,678. The patients signed the Free and Informed toms were presented by patients, more diagnoses of degenerative Consent Term (FICT) before signing the survey. changes were obtained. Evaluating the prevalence of degenerative changes in the articu- Statistical analyses lar eminence region observed in the tomography exam in the The absolute and relative frequencies of changes found were group that did not receive a clinical diagnosis of TMD, five indi- presented and the relationship between the presence of imag- viduals had planning in at least one TMJ and four had sclerosis, ing changes, clinical diagnostics, and pain symptoms was shown however, in none of the study participants was the presence of osteophytes and/or erosion in this structure observed. In the group with TMD, but without a group III clinic diagnosis Table 1. Clinical diagnosis of individuals, carried out by applying the (n=15), it was observed that 100% of those evaluated had flat- RDC/TMD questionnaire tening in at least one TMJ, 93.3% had sclerosis, 73.3% osteo- No TMD Without group III With group III phytes, and 40% had erosions. clinic diagnosis clinic diagnosis Of the participants with a group III clinic diagnosis, in those Group I Group II Arthralgia Degenerative with arthralgia (n=12), 83.3% had flattening, 66.6% sclero- changes sis, 58.3% osteophytes, and 41.6% erosions. In the group 7 (18.5%) 12 (31.5%) 3 (8%) 12 (31.5%) 4 (10.5%) clinically diagnosed as presenting osteoarthritis or osteoar- Total 15 (39.5%) 16 (42%) throsis (n=4), the values found were respectively 50, 50, 25 TMD = temporomandibular joint disorder. and 25% (Table 3).

Table 2. Assessment of the presence of pain by RDC/TMD clinic diagnosis groups Presence of pain No TMD Without group III clinic With group III clinic diagnosis (n=16) (n=7) diagnosis (n=15) Arthralgia (n=12) Degenerative changes (n=4) During active mouth opening 2 (28.5%) 7 (46.6%) 9 (75%) 1 (25%) During excursive movements 0 (0%) 8 (53.3%) 9 (75%) 2 (50%) On lateral palpation 0 (0%) 7 (46.6%) 10 (83.3%) 4 (100%) On intra-auricular palpation 2 (28.5%) 7 (46.6%) 10 (83.3%) 2 (50%) TMD = temporomandibular joint disorder.

224 Relationship between symptoms and imagenological signs of degenerative BrJP. São Paulo, 2020 jul-sep;3(3):222-7 temporomandibular joint disorders using the Research Diagnostic Criteria for Temporomandibular Disorders and cone-beam computed tomography

Table 3. Prevalence of degenerative changes in the articular eminence region by RDC/TMD clinic diagnosis groups No TMD (n=7) Without group III clinic With group III clinic diagnosis (n=16) diagnosis n=15) Arthralgia (n=12) Degenerative changes (n=4) Planning 5 (71.4%) 15 (100%) 10 (83.3%) 2 (50%) Sclerosis 4 (57.1%) 14 (93.3%) 8 (66.6%) 2 (50%) Osteophytes 0 (0%) 11 (73.3%) 7 (58.3%) 1 (25%) Erosion 0 (0%) 6 (40%) 5 (41.6%) 1 (25%) TMD = temporomandibular joint disorder.

Table 4. Prevalence of degenerative changes in the mandibular condyle region by RDC/TMD clinic diagnosis groups No TMD Without group III clinic With group III clinic diagnosis (16) (n=7) diagnosis (n=15) Arthralgia (n=12) Degenerative changes (n=4) Planning 7 (100%) 12 (80%) 7 (58.3%) 3 (75%) Sclerosis 6 (85.7%) 12 (80%) 8 (66.6%) 2 (50%) Osteophytes 3 (42.8%) 7 (46.6%) 4 (33.3%) 1 (25%) Erosion 1 (14.2%) 4 (26.6%) 3 (25%) 0 (0%) TMD = temporomandibular joint disorder.

Figure 1. Cone bean computed tomography of different temporomandibular joints analyzed in parasagital sections (a) osteophyte in the condyle; (b) sclerosis; (c) planning; (d) erosion; (e) generalized sclerosis in the articular eminence and subchondral pseudocyst in the condyle

Regarding the presence of osteodegenerative imaging signs in DISCUSSION the mandibular condyle region (Figure 1), 100% of those assessed as without TMD had flattening, 85.7% sclerosis, 42.8% Degenerative changes of the TMJ are a group of disorders osteophytes, and 14.2% erosion. Of the 15 individuals without related to advancing age and are characterized as the most a clinic diagnosis of painful or degenerative conditions, 80% prevalent pathological condition that affect this joint17. The showed flattening, 80% sclerosis, 46.6% osteophytes, and 25% RDC/TMD is the research tool most widely used today for showed erosion, seen in imaging. In those diagnosed with ar- the diagnosis of TMD. Even so, although it aims for mini- thralgia exclusively, it was observed that 58.3% had flattening in mum inter-observer differences in its diagnoses, its accuracy at least one TMJ, 66.6%sclerosis, 33.3% osteophytes, and 25% in the clinic diagnosis of degenerative processes is unknown, had erosion. While in those with a clinic diagnosis of osteoar- since there are no clinical criteria considered the gold stan- thritis or osteoarthrosis (RDC/TMD), 75% had flattening, 50% dard for the diagnosis of deterioration of the TMJ9, which sclerosis, 25% osteophytes, and no participant had erosion in the highlights the need for images for accurate diagnosis of such mandibular condyle region (Table 4). According to Spearman’s changes9,17. test, there was no statistically significant relationship between the In a previous study18, six specialists in TMD and Orofacial amount of imaging-based changes and the number of clinical Pain assessed 204 patients clinically, using the RDC/TMD diagnoses of group III (r=-0.0896, p=0.59). However, the result and they compared the clinical diagnosis with the presence suggests that the higher the number of imaging-based changes of imaging changes found in the conventional tomography present, the lower the number of correct diagnoses obtained by exam. According to the results, it was observed that the the RDC/TMD (negative correlation). specialists underestimated the presence of imaging changes There also was no significant correlation between the presence (including the presence of osteophytes, flattening, sclerosis, of symptoms and image-based changes (r=0.1032, p=0.5374). and erosion). This demonstrates that the clinical diagno- 225 BrJP. São Paulo, 2020 jul-sep;3(3):222-7 Silva BM, Pinto RA, Bonato LL, Bezerra-Júnior AA, Grossmann E and Ferreira LA sis of degenerative diseases has high specificity (ability to presence of each sign and symptom, even if subclinical or correctly identify TMJs without changes) (0.86 to 0.94), perceived only by the professional. Some authors propose and low sensitivity (ability to correctly identify TMJs with an optimization of the method of perception of joint sounds changes) (0.14 to 0.40), with regard to osteodegenerative using a stethoscope, as recommended22. changes. The present study evaluated only patients who had Another explanation for the lack of association between degenerative changes observed via CBCT exam, and did not the presence of clinical symptoms and the imaging findings include a group of healthy individuals, considered the “con- (r=0.1032, p=0.5374) is that the joint cartilages in the ini- trol”. However, the clinical diagnosis of osteoarthritis/osteo- tial stages are often not seen in the images and the bone arthrosis made exclusively with the RDC/TMD comprised alterations that manifest sufficiently enough to be detected only 10.5% of the cases evaluated, revealing how much the in these exams take a lot of time to develop18. Likewise, the degenerative processes are clinically underdiagnosed, since different kinds of images used also make the results distinct the entire sample had some image-based sign of osteode- and hard to be combined23. In the study20, considering the generation. presence of changes in the mandibular head, mandibular The most common signs and symptoms that accompany this fossa, and tuber joint, a prevalence of 78.5% of flattening, process include joint or ear local pain, stiffness in the face 34.8% of osteophytes, 35.2% of erosion and 17.6% of scle- and jaw, pain and limitation during mouth opening, pain rosis was found. when chewing, jaw crackling, and joint noises19. However, to The author used the conventional tomography exam, while date, considering previous studies that used different clinical the present study used CBCT specifically to cranio-maxillo- exam protocols, as well as different radiographic techniques, facial area, which explains the larger prevalence of osteode- it has not been possible to describe which imaging findings generative alterations evaluated by the CBCT. could be predicted from a clinical examination of the TMJ As stated by other researches12,24, CBCT shows minimiza- and adjacent structures18. What is known is that the pres- tion of image artifacts and specific resolution for cortical ence of coarse crackling of the TMJ, as well as increased age assessment of the cranio-maxillofacial area, including bone and the influence of gender (women), present increased risk components of the TMJ. This fact was considered for choos- of having degenerative changes of the TMJ, while there are ing the image acquisition method adopted by the present no variables related to pain that are associated with imaging study. For many years, scientific research on TMD has dealt findings18,20. In the present study, considering the clinical with the difficulty of comparing results of studies involv- characteristics of sex and age, 89.5% of the female sample ing TMD patients due to the lack of a clinical diagnostic was found and the mean age was 48.8±9.2 years, slightly protocol. RDC/TMD and, more recently, DC/TMD have higher than what is described in the literature. The average contributed a lot to solving this problem, however, there are age among patients with TMJ osteoarthritis was 36 ± 15.6 many studies that do not use these instruments25. CBCT, years, while the prevalence of women was 81.5% in another in addition to being effective for diagnosing temporoman- study21. A survey of Chinese women with osteoarthritis/ dibular arthrogenic disorders, has the advantage of its low osteoarthrosis8 revealed a mean age of 33.5±14.3 years. radiation dose and lower cost compared to conventional Also, according other study20, clinically evaluating the vari- tomography23. However, it also differs from radiographic ables related to the presence of pain (muscle or joint), its methods in that it reproduces a section of the human body intensity and duration, and depression scores, it was not in any of the three spatial planes, allowing the visualization possible to associate them with the presence of degenera- of all stratified structures, especially mineralized tissues, in tive changes in the TMJ. Similarly, in our assessment, the addition to delimiting three-dimensional irregularities24,26. presence of pain during active mouth opening, during ex- Therefore, it is believed that degenerative TMJ changes have cursive movements, pain on lateral and intra auricular pal- a considerable prevalence in the population with TMD and pation, showed no significant statistical difference between that the number of cases of osteoarthritis may be underdi- the groups. However, according to the Spearman correlation agnosed. test, it was observed that as more symptoms were presented It is also considered that more well-designed prospective by the patients, more imaging diagnoses were obtened. Ana- studies are needed to verify the prevalence in the general lyzing the results, it is even possible to observe that 31.5% population27. of the individuals had arthralgia, whose diagnosis was clear It can also be learned that other changes, such as disc dis- and evidenced by RDC/TMD. According to the RDC/ placement, are involved in the manifestation of arthral- TMD, the presence of crackling is considered a clinical sign gia15,27 and that other diagnostic tools, such as MRI for soft of the degenerative disorder, that is, related to osteoarthritis tissue evaluation, can clarify this possible association27. (group III), due to the change in intra-articular lubrication and possible friction between its components. However, the CONCLUSION results of the present study revealed a low frequency of this signal, even in group III patients. These findings, as pointed Arthralgia was the most observed condition among the indi- out by the authors of DC/TMD11, emphasize the impor- viduals evaluated after using the RDC/TMD. There was a posi- tance of standardized clinical examination, considering the tive association between the amount of joint symptoms and the 226 Relationship between symptoms and imagenological signs of degenerative BrJP. São Paulo, 2020 jul-sep;3(3):222-7 temporomandibular joint disorders using the Research Diagnostic Criteria for Temporomandibular Disorders and cone-beam computed tomography number of conclusive clinical diagnoses obtained by the RDC/ 13. Martinez-Blanco M, Bagán JV, Fons A, Poveda Roda R. Osteoarthrosis of the temporomandibular joint. A clinical and radiological study of 16 patients. Med Oral. TMD. It is suggested that further studies be carried out using 2004;9(2):110-5. cone beam TCy, comparing their findings with clinical informa- 14. Milam SB. Pathophysiology and epidemiology of TMJ. J Musculoskelet Neuronal Interact. 2003;3(4):382-90. tion, so that it is possible to evaluate other associations between 15. Ahmad M, Hollender L, Anderson Q, Kartha K, Ohrbach R, Truelove EL, et al. signs, symptoms, and osteodegenerative changes of the TMJ. 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227 BrJP. São Paulo, 2020 jul-sep;3(3):228-33 ORIGINAL ARTICLE

Predictive factors of chronic lower back pain risk in women: population- based study Fatores preditivos de risco de lombalgia crônica em mulheres: estudo de base populacional

Patrícia Cilene Freitas Sant´Anna1, Guilherme Watte2, Anderson Garcez1,3, Stephan Altmayer2, Maria Teresa Anselmo Olinto1,4, Juvenal Soares Dias da Costa1,5

DOI 10.5935/2595-0118.20200050

ABSTRACT (OR=2.97; 95%CI: 1.59-5.55), smoking (OR=1.61; 95%CI: 1.07-2.44), and multiparity (OR=2.84; 95%CI: 1.45-5.57). BACKGROUND AND OBJECTIVES: Low back pain is a Skin color, marital status, and obesity were not associated with a common condition in women. In addition to that, women have higher risk of chronic low back pain. a higher risk of chronic pain. However, the factors associated CONCLUSION: This study indicates that the predictive factors with chronic low back pain are still controversial. Thus, this stu- associated with a higher risk of chronic low back pain in wo- dy’s objective was to evaluate the predictive factors associated men included advanced aged, socioeconomic disadvantage, poor with a higher risk of chronic low back pain. health behaviors and multiparity. METHODS: A cross-sectional population-based study was con- Keywords: Causality, Chronic pain, Low back pain, Women. ducted on a sample of 636 Brazilian adult women aged 20-69 years who reported symptoms of low back pain in the last two RESUMO weeks. The level of risk of chronic low back pain was measured by the validated Brazilian version of Subgroups for Targeted JUSTIFICATIVA E OBJETIVOS: A dor lombar é uma condi- Treatment (STarT) score. ção comum em mulheres. Além disso, essa população apresenta RESULTS: The risk of chronic low back pain was classified as maior risco de dor crônica. No entanto, os fatores associados à low, medium, and high in 330 (51.9%), 202 (31.8%), and 104 dor lombar crônica ainda são controversos. Assim, este estudo (16.4%) women, respectively. After adjustments, the main fac- teve como objetivo avaliar os fatores de predisposição associados tors associated with a higher risk of chronic low back pain were: ao maior risco de dor lombar crônica. aged 50 years or older (OR=2.67; 95%CI: 1.43-4.96), low hou- MÉTODOS: Foi realizado um estudo transversal de base po- sehold income (OR=2.23; 95%CI: 1.34-3.72), 4 years of edu- pulacional em uma amostra de 636 mulheres adultas brasileiras cation or less (OR=2.17; 95%CI: 1.35-3.48), sedentary lifestyle com idades entre 20 e 69 anos que relataram sintomas de dor lombar nas últimas duas semanas. O nível de risco de dor lombar crônica foi medido pela versão brasileira validada do escore Patrícia Cilene Freitas Sant’Anna – https://orcid.org/0000-0002-8278-8692; Subgroups for Targeted Treatment (STarT). Guilherme Watte – https://orcid.org/0000-0002-6948-3982; RESULTADOS: O risco de dor lombar crônica foi classificado Anderson Garcez – https://orcid.org/0000-0003-1111-4890; Stephan Altmayer – https://orcid.org/0000-0001-9214-1916; como baixo, médio e alto em 330 (51,9%), 202 (31,8%) e 104 Maria Teresa Anselmo Olinto – https://orcid.org/0000-0002-3950-4594; (16,4%) mulheres, respectivamente. Após os ajustes, os princi- Juvenal Soares Dias da Costa – https://orcid.org/0000-0003-3160-6075. pais fatores associados ao maior risco de dor lombar crônica fo- 1. Universidade do Vale do Rio dos Sinos, Programa de Pós-Graduação em Saúde Coletiva, ram: idade de 50 anos ou mais (RC=2,67; IC95%: 1,43-4,96), São Leopoldo, RS, Brasil. 2. Pontifícia Universidade Católica do Rio Grande do Sul, Programa de Pós-Graduação em baixa renda familiar (RC=2,23; IC95%: 1,34-3,72), 4 anos de Medicina e Ciências da Saúde, Porto Alegre, RS, Brasil. estudo ou menos (RC=2,17; IC95%: 1,35-3,48), estilo de vida 3. Universidade Federal de Ciências da Saúde de Porto Alegre, Programa de Pós-Graduação sedentário (RC=2,97; IC95%: 1,59-5,55), tabagismo (RC=1,61; em Ciências da Nutrição, Porto Alegre, RS, Brasil. 4. Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Alimenta- IC95%: 1,07-2,44) e multiparidade (RC=2,84; IC95%: 1,45- ção, Nutrição e Saúde, Porto Alegre, RS, Brasil. 5,57). A cor da pele, o estado civil e a obesidade não foram asso- 5. Universidade Federal de Pelotas, Departamento de Medicina, Pelotas, RS, Brasil. ciados a um maior risco de dor lombar crônica. Submitted on February 11, 2020. CONCLUSÃO: Este estudo indicou que os fatores de predispo- Accepted for publication on July 12, 2020. Conflict of interests: none – Sponsoring sources: This work was supported by the National sição associados a um maior risco de lombalgia crônica em mu- Council of Technological and Scientific Development (CNPq, grant number 457235/2014- lheres incluíram idade avançada, desvantagem socioeconômica, 4). The funders had no role in study design, data collection and analysis, decision to publish comportamentos de saúde inadequados e multiparidade. and the preparation or approval of the manuscript. Descritores: Causalidade, Dor crônica, Dor lombar, Mulheres. Correspondence to: Juvenal Soares Dias da Costa Av. Unisinos 950, Caixa Postal 275 INTRODUCTION 93022-000 São Leopoldo, RS, Brasil. E-mail: [email protected] Lower back pain (LBP) is a highly prevalent disease with social © Sociedade Brasileira para o Estudo da Dor consequences and economic implications for the health system1,2. 228 Predictive factors of chronic lower back pain risk BrJP. São Paulo, 2020 jul-sep;3(3):228-33 in women: population-based study

The prevalence of LBP is higher in women, and this population The level of risk of chronic LBP was assessed using the pre- have a higher risk of chronic pain3-6. viously validated Brazilian version of the STarT Back Scree- The LBP process begins with an acute phase that may progress to ning Tool16. The LBP was identified by the presence of pain resolution or become chronic. This condition depends on the res- or discomfort between the last rib and the lowermost level ponse of the pain and its psychosocial impact3,7. Previous studies of the gluteal region. In addition, a figure illustration of the have also demonstrated that important sociodemographic, lifesty- body region was used as previous indicated17. The STarT Back le, and reproductive factors are associated with the occurrence of Screening Tool is composed of four primary questions related persistent LBP. Individuals with advanced age and with socioe- to pain, disability and comorbidity, and five questions related conomic disadvantage are more vulnerable to the occurrence of to the psychosocial impact of pain. As for results, a score is LBP5,8-10. In addition, low level of physical activity11, smoking8,12 generated and posteriorly stratified in ‘low risk’ (≤3 points), and multiparity are also related to a higher probability of LBP9,13. ‘medium’ or ‘high’ risk if more than 3 points are scored. When There are several instruments for the assessment of LBP14. Ho- the score results in 3 points or more, the psychosocial scale wever, a primary care back pain screening tool was developed is used to classify ‘medium’ risk (zero-3 points in the psycho- and validated to identify and assess subgroups more prone to social questions) and ‘high risk’ (4 points in the psychosocial have chronic LBP: Subgroups for Targeted Treatment (STarT). The questions)16. The STarT screening questionnaire was applied StarT Back Screening Tool14,15. Additionally, this tool measures in all participants who reported the presence of LBP symp- the status and the impact of acute LBP in daily life activities and toms in the previous two weeks. in the psychosocial aspects16. The following potential sociodemographic, lifestyle and repro- Considering the above-mentioned notes and the social context ductive characteristics were investigated: age categorized every of a developing country, this study aimed evaluate the predicti- 10 years; skin color; marital status; family income; level of edu- ve factors associated with a higher risk of LBP assessed by the cation in years of study; level of physical activity, considering as StarT screening tool in a population sample of adult women in ‘active’ those who reported a minimum weekly practice of 75 Southern Brazil. The determination of these factors could help minutes of vigorous activity or 150 minutes of moderate activity identify those at a high risk of developing chronic pain and plan assessed by the short version of the International Physical Ac- preventive interventions. tivity Questionnaire (IPAQ)18; smoking; parity and nutritional status obtained by body mass index (BMI). METHODS Statistical analysis A cross-sectional population-based study was carried out in the Data was presented as for absolute and relative frequency (per- urban area of a Southern Brazil city. A representative sample of centage) and bivariate analysis was conducted using Pearson’s women aged 20 to 69 years and who reported LBP in the pre- Chi-squared test to measure the association between the inde- vious two weeks was selected using multistage systematic sam- pendent variables and outcomes. Unadjusted and adjusted odds pling. First, 45 census tracts from the 371 existing tracts in the ratio (OR) with their corresponding 95% confidence interval urban area of the municipality were selected based on the mon- (95%CI) were calculated by ordinal logistic regression, using the thly income per capita in each sector. For each selected census proportional odds model. The technique estimates the odds that tract, a census block and corresponding street corner were ran- the dependent variable will shift to a higher category as a func- domly selected to identify the household from which to initiate tion of increases in the independent variables. The assumption data collection. Houses were alternately selected (each time ski- of proportionality in the model was assessed using the Brant test. pping the next two houses) until the total number of necessary The gologit2 command (STATA) was used with autofit to fit the households for each tract was reached. coefficients of the categories of variables in which the propor- The sample size for the assessment of the chronic LBP risk level tional odds assumption was violated19. Only variables that sho- was calculated using Epi Info 6.0 (CDC, Atlanta, USA). A total wed a p-value lower than 5% (p<0.05) were maintained in the of 460 participants were estimated, considering a confidence le- adjusted model (variables adjusted to each other). A two-tailed vel of 95%, a power of 80%, and a 25% increase to compensate statistically significant difference was defined at 5% (p<0.05). All for nonresponses (refusal/losses). The final sample after recruit- analyses were performed using Stata, version 12.0 (StataCorp LP, ment was composed of 636 women, with a proportion of 3:1 College Station, Texas, USA). (controls vs. exposed), which resulted in a confidence level of 99% and a power of 80% for an odds ratio of two. RESULTS Interviews were administered by previously trained interviewers at the participants’ homes. Women who were pregnant at the A total of 1128 women were initially interviewed in this popu- time of the study, who were intellectually disabled or had a his- lation-based study, and from these, 636 (56.4%) reported LBP tory of lumbar fracture or surgery in the last six months were in the last two weeks prior to the interview date, being included excluded. Telephone interviews were conducted with a randomly in the final analysis. Table 1 shows the general characteristics of selected portion (10%) of the sample to verified data consistency. the investigated sample. Most women were aged 40-49 years old Individuals who refused to participate initially were later contac- (64.5%), white skin color (74.1%), married (65.6%), family in- ted at least twice on different days and time. come less than one Brazilian minimum wage (64.2%), eight or 229 BrJP. São Paulo, 2020 jul-sep;3(3):228-33 Sant´Anna PC, Watte G, Garcez A, Altmayer S, Olinto MT and Costa JS more years of education (55.6%), insufficiently active (88.4%), me, level of education, level of physical activity, smoking, parity, non-smoking (55.9%), with 1-2 childbirths (51.7%) and obese and nutritional status (Table 2). (38.3%) (Table 1). The final adjusted multivariate regression model is shown in The risk of chronic LBP was classified as low, medium, and high table 2. After adjustments, the main factors associated with a in 330 (51.9%; 95%CI: 48.0-55.8), 202 (31.8%; 95%CI: 28.1- higher risk of chronic LBP were: age 50 years or older (OR=2.67; 35.4), and 104 (16.4%; 95%CI: 13.5-19.2) women, respecti- 95%CI: 1.43-4.96), low household income (OR=2.23; 95%CI: vely. Taken into account the main results obtained in the biva- 1.34-3.72), 4 years of education or less (OR=2.17; 95%CI: riate analysis (unadjusted analysis), the factors associated with a 1.35-3.48), sedentary lifestyle (OR=2.97; 95%CI: 1.59-5.55), higher risk of chronic LBP were age, skin color, household inco- smoking (OR=1.61; 95%CI: 1.07-2.44), and multiparity

Table 1. General sample characteristics and the distribution by the level of risk of chronic low back pain in adult women in Southern Brazil (n=636) Characteristics n=636 Level of risk of chronic lumbar back pain p-valuea n (%) Low Medium High n=330 n=202 n=104 n (%) n (%) n (%) Age (years) <0.001 20-29 100 (15.7) 74 (74.0) 22 (22.0) 4 (4.0) 30-39 126 (19.8) 78 (61.9) 30 (23.8) 18 (14.3) 40-49 173 (27.2) 79 (45.7) 56 (32.4) 38 (22.0) 50-59 141 (22.2) 60 (42.6) 49 (34.8) 32 (22.7) 60-69 96 (15.1) 39 (40.6) 45 (46.9) 12 (12.5) Skin color 0.04 White 471 (74.1) 256 (54.4) 147 (31.2) 68 (14.4) Non-white 165 (25.9) 74 (44.8) 55 (33.3) 36 (21.8) Marital status 0.02 Single 107 (16.8) 64 (59.8) 31 (29.0) 12 (11.2) Married 417 (65.6) 221 (53.0) 124 (29.7) 72 (17.3) Divorced/widowed 112 (17.6) 45 (40.1) 47 (41.9) 20 (17.8) Family income in USD (n=620) <0.001 >1100 147 (23.7) 52 (35.3) 62 (42.1) 33 (22.4) 700-1100 180 (29.3) 91 (50.5) 54 (30.0) 35 (19.4) 400-699 159 (25.6) 91 (57.2) 46 (28.9) 22 (13.8) <400 134 (21.6) 89 (66.4) 35 (26.1) 10 (7.4) Education level (years) (n=635) <0.001 ≤4 126 (19.8) 35 (27.8) 52 (41.3) 39 (30.9) 5-8 156 (24.6) 64 (41.0) 64 (41.0) 28 (17.9) >8 353 (55.6) 230 (65.2) 86 (24.4) 37 (10.5) Physical activity level <0.001 Active 74 (11.6) 59 (79.7) 12 (16.2) 3 (4.1) Insufficiently active 562 (88.4) 271 (48.2) 190 (33.8) 101 (18.0) Smoking history (n=632) <0.001 Never smoker 353 (55.9) 202 (57.2) 105 (29.7) 46 (13.0) Ex-smoker 134 (21.2) 49 (36.6) 50 (37.3) 35 (26.1) Smoker 134 (21.2) 49 (36.6) 50 (37.3) 35 (26.1) Parity <0.001 No children 96 (15.1) 68 (70.8) 21 (21.9) 7 (7.3) 1 children 147 (23.7) 97 (65.9) 39 (26.5) 11 (7.4) 2 children 181 (28.4) 92 (50.8) 65 (35.9) 24 (13.2) 3 children 120 (18.8) 49 (40.8) 41 (34.1) 30 (25.0) ≥4 children 92 (14.4) 24 (26.0) 36 (39.1) 32 (34.7) Nutritional status (n=634) 0.01 Normal (BMI<25kg/m2) 182 (28.7) 106 (58.2) 52 (28.6) 24 (13.2) Overweight (25≤BMI<30kg/m2) 209 (33.0) 115 (55.0) 58 (27.8) 36 (17.2) Obese (BMI≥30kg/m2) 243 (38.3) 108 (44.4) 91 (37.4) 44 (18.1) a p-values for Chi-square test for heterogeneity of proportions; BMI = body mass index.

230 Predictive factors of chronic lower back pain risk BrJP. São Paulo, 2020 jul-sep;3(3):228-33 in women: population-based study

Table 2. Unadjusted and adjusted ordinal logistic regression, Oddis Radio, and 95% Confidence interval for the level of risk of chronic low back pain, according to the predictive factors investigated in adult women in Southern Brazil (n=636) Characteristics Unadjusted p-value Adjusteda p-value Low vs (medium+high-risk) OR (95%CI) OR (95%CI) Age (years) <0.001 0.021 20-29 1.00 (reference) 1.00 (reference) 30-39 1.91 (1.08-3.36) 1.41 (0.75-2.65) 40-49 3.70 (2.18-6.26) 2.50 (1.36-4.60) 50-59 4.10 (2.38-7.05) 2.67 (1.43-4.96) 60-69 3.55 (2.01-6.30) 1.86 (0.93-3.72) Skin color 0.015 Non-white 1.00 (reference) -- White 1.51 (1.08-2.12) Marital status 0.006 Single 1.00 (reference) -- Married 1.38 (0.90-2.10) Divorced/widowed 2.01 (1.21-3.33) Family income, USD <0.001 0.002 >1100 1.00 (reference) 1.00 (reference) 700-1100 1.53 (0.96-2.44) 1.23 (0.74-2.03) 400-699 2.10 (1.33-3.29) 1.54 (0.94-2.53) <400 3.39 (2.13-5.38) 2.23 (1.34-3.72) Education level (years) <0.001 0.001 >8 1.00 (reference) 1.00 (reference) 5-8 2.47 (1.72-3.55) 1.36 (0.91-2.05) ≤4 4.59 (3.08-6.81) 2.17 (1.35-3.48) Physical activity level <0.001 <0.001 Active 1.00 (reference) 1.00 (reference) Insufficiently active 4.27 (2.37-7.68) 2.97 (1.59-5.55) Smoking history <0.001 0.007 Never smoker 1.00 (reference) 1.00 (reference) Ex-smoker 1.21 (0.83-1.75) 1.09 (0.73-1.64) Smoker 2.33 (1.60-3.40) 1.61 (1.07-2.44) Parity <0.001 <0.001 No children 1.00 (reference) 1.00 (reference) 1 children 1.22 (0.70-2.12) 1.05 (0.58-1.89) 2 children 2.26 (1.35-3.80) 1.25 (0.70-2.24) 3 children 3.81 (2.19-6.64) 1.77 (0.94-3.32) ≥4 children 6.96 (3.87-12.5) 2.84 (1.45-5.57) Nutritional status 0.008 Normal (BMI<25kg/m2) 1.00 (reference) -- Overweight (25≤BMI<30kg/m2) 1.18 (0.80-1.75) Obese (BMI≥30 kg/m2) 1.65 (1.14-2.39) BMI = body mass index; OD = odds ratio; CI = confidence interval;a the ‘low-risk’ of chronic LBP category obtained by the STarT score was used as the reference group (‘low-risk’ vs ‘medium+high-risk’). The final adjusted model was evaluated using the Brant test in order not to violate the proportional odds assumption. Only variables that showed a p-value lower than 5% (p<0.05) were maintained in the adjusted model (variables adjusted to each other).

(OR=2.84; 95%CI: 1.45-5.57). Sedentary lifestyle (insufficient DISCUSSION level of physical activity) remained as the factor with the higher strength of the association with chronic LBP in the final adjus- This cross-sectional study addressed sociodemographic, lifestyle, ted model. The results for age, income, education, and parity and reproductive factors that are associated with the prevalence showed a significant linear trend association with the level of risk of chronic risk levels in women reporting LBP. It was revealed of chronic LBP (Table 2). Skin color, marital status, and obesity that 16.4% of the investigated women had high risk for deve- were not associated with a higher risk of chronic LBP. loping chronic LBP. In addition, this study indicated that the 231 BrJP. São Paulo, 2020 jul-sep;3(3):228-33 Sant´Anna PC, Watte G, Garcez A, Altmayer S, Olinto MT and Costa JS predictive factors associated with a higher risk of chronic LBP Despite the strengths, the results of this investigation must be in- in women included advanced age, socioeconomic disadvantage, terpreted with some limitations. Firstly, due to the cross-sectional poor health behaviors and multiparity. design of the study, it does not establish a temporal relationship The current scientific literature shows important relationships between events, and a reverse causation cannot be completely between sociodemographic factors and the occurrence of LBP. ruled out; therefore, the observed association between chronic Advanced age is an important risk factor for chronic LBP5,8-10. LBP and physical inactivity, for example, should be treated with Age increases the degenerative musculoskeletal process, which caution. It is very possible that women with LBP reduce their may result in a negative prognosis of LBP10,20-22. Additionally, in- physical activity. Thus, it’s suggested that further longitudinal dividuals with chronic LBP are socioeconomically disadvantaged research is warranted in order to investigate this relationship in and with less educational level8. In this way, these individuals are other women samples. Secondly, the STarT Back Screening Tool often covered by government-sponsored health insurance and is a stratification instrument used to indicate the potential risk visit healthcare providers more frequently, resulting in socioeco- for chronic pain, however, this instrument did not provide the nomic disparities8. condition diagnosis. Regarding lifestyle factors, insufficient physical activity was Furthermore, given that many of the women studied were in highly prevalent in this women population. Although the asso- their reproductive years and have been menstruating, they could ciation of LBP and a sedentary lifestyle is controversial in the have reported menstrual pain as back pain. Moreover, the golo- literature11, insufficient physical activity was the strongest predic- git2 command was applied considering the ‘low-risk’ of chronic tive factor associated with high risk of LBP in the present study. LBP as the reference group (‘low-risk’ vs ‘medium+high-risk’). However, substantial evidence supports the use of physical exer- This procedure was adopted to avoid loss of power in the analy- cise in the primary and secondary prevention of chronic LBP, zes, due to the low number of women in the highest category of and as an adjunct treatment in individuals with active chronic chronic LBP. Finally, a screening question contemplating only pain23. Regular physical activity has been linked to the stimu- the previous two weeks was used to learn if a participant expe- lation of brain regions involved in descending pain inhibition, rienced recent LBP. In fact, in this study there was no informa- thus decreasing their sensitivity to pain24. Smoking has also been tion on duration of chronic pain symptoms. linked to chronic LBP in previous studies8,12. This association can be explained by the chronic cough provoked by smoking, CONCLUSION which increases the intra-abdominal and the intervertebral discs pressure. It was also hypothesized that the cigarette smoke-indu- This study indicated that the predictive factors associated with a ced vasculopathy affects the nutrition of the intervertebral discs, higher risk of chronic LBP in women include advanced age, so- which can lead to the development of discopathy. In addition, cioeconomic disadvantage, poor health behaviors and multiparity. smoking may reduce the resistance of the lumbar back muscles. Additionally, a high prevalence for chronic LBP was revealed. The prevalence of LBP during pregnancy is well known and es- Thus, due to the possible impact of LBP to society as well as the timated to affect 50-80% of women in the last two trimesters of disability resulting from LBP, it’s important to highlight the prio- pregnancy25,26. Pregnant women were excluded from the survey, rity for the implementation of preventive healthcare programs. however, childbearing is associated with increased lifting and carrying, according to the mechanical and psychological demands ACKNOWLEDGMENTS related to children care13. Moreover, this study demonstrated that a history of multiparity is associated with a higher risk of AG received post-doctoral fellowship (CNPq-Brasil; process chronic LBP. Similar findings previously reported that childbea- n. 152923/2018-7) and MTAO received research productivity ring and childrearing increases the risk of LBP9,13. grant (CNPq-Brasil; process n. 307175/2017-0) from the Bra- This study presented an original scientific research and impor- zilian National Council of Technological and Scientiﬁc Develo- tant predictive factors associated with LBP in a representative pment – CNPq. population-based sample of young and middle-aged women living in the urban area of Southern Brazil city were investigated. REFERENCES The other strength of this study is that an adapted, translated, 14,16 1. Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of and validated screening tool to assess chronic LBP was used. the global prevalence of low back pain. Arthritis Rheum. 2012;64(6):2028-37. The STarT Back Screening Tool is specifically designed for pri- 2. 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233 BrJP. São Paulo, 2020 jul-sep;3(3):234-8 ORIGINAL ARTICLE

Interference of the Carpal Tunnel syndrome symptoms on occupational performance Interferência dos sintomas da síndrome do Túnel do Carpo no desempenho ocupacional

Kátine Marchezan Estivalet1, Carmine Thomas1, Aline Sarturi Ponte1, Dyannder da Silva Porciuncula Pinto2, Miriam Cabrera Corvelo Delboni1

DOI 10.5935/2595-0118.20200052

ABSTRACT CONCLUSION: It was noticed that the Carpal Tunnel syndrome interferes with occupational performance, as well as that pain BACKGROUND AND OBJECTIVES: The Carpal Tunnel is the main complaint. syndrome is characterized as the compression syndrome with the Keywords: Carpal Tunnel syndrome, Nerve crush, Orthopedics, highest incidence in the population, impairing the upper limbs Upper extremity. and, consequently, occupational performance. The objective of this study was to identify the symptoms of the compression syn- RESUMO drome and the impact of the disease on upper extremity disorders in relation to occupational performance. JUSTIFICATIVA E OBJETIVOS: A síndrome do Túnel do METHODS: This is a quantitative study with a descriptive Carpo caracteriza-se por ser a compressiva de maior incidência approach, conducted with adults, both male and female, diagno- na população, comprometendo os membros superiores e, con- sed with Carpal Tunnel syndrome. There was an initial evalua- sequentemente o desempenho ocupacional. O objetivo deste es- tion to identify pain, edema, paresthesia, sensitivity alteration, tudo foi identificar os principais sintomas da síndrome compres- and muscle weakness. The Disabilities of the Arm, Shoulder and siva e o impacto da doença nas desordens da(s) extremidade(s) Hand was used to assess the performance of fine motor activities superior(es) em relação ao desempenho ocupacional. as well as broader movements that require motor skills. This stu- MÉTODOS: Trata-se de um estudo quantitativo com abordagem dy used only the part of the instrument that evaluates the seve- descritiva, realizado com pessoas adultas diagnosticadas com sín- rity of symptoms concerning the week before the interview and drome do Túnel do Carpo, de ambos os sexos. Houve a realização other implications as pain, discomfort and weakness, difficulty de avaliação inicial para identificar dor, edema, parestesia, altera- in moving the upper limb, and to sleep. ção da sensibilidade e fraqueza muscular. O Disabililies of the Arm, RESULTS: Fifteen adults diagnosed with the Carpal Tunnel syn- Shoulder and Hand também foi usado para avaliar a capacidade de drome participated in this study (27 affected limbs), being the realizar movimentos motores finos, bem como movimentos mais dominant side the most undermined. The main complaint was amplos e que exigem capacidades motoras. No presente estudo, pain, with higher intensity at night, followed by paresthesia. The utilizou-se apenas a parte do instrumento que avalia a gravidade Carpal Tunnel syndrome also compromises occupational perfor- dos sintomas em relação à semana anterior da entrevista, além de mance, especially in activities using hands, and in sleep quality. outras implicações como dor, desconforto, fraqueza, dificuldade em mover o membro superior e dificuldade para dormir. RESULTADOS: Participaram do estudo 15 pessoas com sín- drome do Túnel do Carpo, totalizando 27 membros acometi- dos, sendo o lado dominante o mais comprometido. A queixa principal foi a dor, com maior intensidade no período noturno, Kátine Marchezan Estivalet – https://orcid.org/0000-0001-9625-5515; seguida de parestesia. A síndrome compromete o desempenho Carmine Thomas – https://orcid.org/0000-0001-7312-2605; Aline Sarturi Ponte – https://orcid.org/0000-0003-4775-3467; ocupacional, principalmente em atividades envolvendo as mãos, Diander da Silva Porciuncula Pinto – https://orcid.org/0000-0001-9665-7186; e na qualidade do sono.  Miriam Cabrera Corvelo Delboni – https://orcid.org/0000-0001-5049-4561. CONCLUSÃO: Percebeu-se que é uma síndrome compressiva 1. Universidade Federal de Santa Maria, Departamento de Terapia Ocupacional, Santa Ma- que interfere no desempenho ocupacional, além de constatar que ria, RS, Brasil. 2. Universidade Federal de Santa Maria, Departamento de Estatística, Santa Maria, RS, Brasil. a dor é a principal queixa. Descritores: Compressão nervosa, Extremidade superior, Orto- Submitted on February 17, 2020. pedia, Síndrome do Túnel do Carpo. Accepted for publication on June 01, 2020. Conflict of interests: none – Sponsoring sources: none. INTRODUCTION Correspondence to: Avenida Roraima, nº 1000 - Prédio 26 Anexo D, sala 4010B – Bairro Comobi 97105-900 Santa Maria, RS, Brasil. The carpal tunnel is a restrict and elliptic space, ventrally confi- E-mail: [email protected] ned by the flexor retinaculum - inelastic and resistant, and dor- © Sociedade Brasileira para o Estudo da Dor sally by the anterior surface of the carpal bones1. In the carpal 234 Interference of the Carpal Tunnel syndrome BrJP. São Paulo, 2020 jul-sep;3(3):234-8 symptoms on occupational performance tunnel, there are four flexor digitorum superficialis tendons and of physical disability, or with a current clinical history of other four flexor digitorum profundus tendons, the flexor pollicis lon- types of neuro-musculoskeletal disease in the upper limbs, and gus tendon, and the median nerve1. people unwilling to participate in the study were excluded, as The Carpal Tunnel syndrome (CTS) is defined by the result from well as those with whom we were unable to contact to schedule the median nerve being pressed in the wrist, and the most com- the data collection. The participants’ pre-selection was by elec- mon cause is idiopathic2, being the neuropathy with the highest tronic form. incidence at the upper extremity1. The environmental risks are There was an initial assessment by a questionnaire with some the most significant2 among the risk factors to trigger the neu- basic questions addressing personal and health issues to identify ropathy, primarily when related to work tasks that require great pain, edema, paresthesia (numbness, tingling, and burning), al- efforts such as carrying heavy loads, incorrect posture when per- terations in sensitivity, and muscle weakness. forming tasks, stress and repetitive movements3. Therefore, CTS The Disabilities of the Arm, Shoulder and Hand (DASH)5 is also considered an occupational disease4. that assesses the capacity to perform fine motor movements The set of the CTS symptoms makes it difficult to perform rou- and broader movements requiring motor skills was also used. tine activities, causing a failure in the integration of the three The present study used only the part of the instrument that elements of occupational performance, namely, the field of per- assesses the severity of the symptoms concerning the week formance, components of performance, and context of perfor- before the interview and other implications such as pain, dis- mance3. So, understanding the diagnosis components, especially comfort, weakness, difficulty in moving the upper limb, and understanding the symptoms related to the interference on the to sleep. Each item received a score on a scale from one to five, occupational performance, improves the decision making about according to the severity level or difficulty, where one is none, the type of intervention necessary as preventive measures, focu- two is small, three is median, four is high, and five is extreme sing on rehab3. severity or difficulty5. Considering the CTS implications, since it is considered a con- The results were tabulated and presented as relative and absolute temporary and disabling2 disease, the objective of this study was frequency and percentage. to identify the key symptoms of the CTS. This allowed us to The Research Ethics Committee approved the study with measure the impact of the disease on upper extremities disorders number CAAE 97504718.8.0000.5346 and opinion number related to occupational performance. 3.468.030/2019. All participants in the study were previously informed and agreed to participate and signed the Free and In- METHODS formed Consent Term (FICT).

This is a quantitative study with a descriptive approach with peo- RESULTS ple diagnosed only with CTS, that is, with the G56.0 code of the International Classification of Diseases and Related Health Pro- Considering the data collection period, of the total of 255 visits blems (ICD-10). The data was collected from June to October at both outpatient clinics, 94.11% of people were excluded due 2019 at the Orthopedics and Traumatology Outpatient Clinic of to the study’s selection criteria. Of them, 37.64% were excluded a university hospital in the Upper Limb and Compressive Syn- due to age, mainly because they were over 60. Also, 46.27% of dromes specialties. the people were excluded due to an impairment of other body The sample was non-probability judgmental sampling that se- function since CTS can present associated diseases, and 45.49% lects the population, based on previously defined inclusion and had only the neuro-musculoskeletal function involved. exclusion criteria. During the data collection period, there were Therefore, the study had 15 participants with the diagnosis of 255 visits at the outpatient clinic, and the sample was selected CTS. Only one participant was male (6.66%), and 14 (93.33%) according to the criteria which objective is the non-interference were female. The mean age was 48 years, ranging from 41 to 59 of other diseases on the study results, detecting specifically the years, considering the adult age group. Among participants, 12 CTS symptoms and their implications on the occupational per- (20% of the cases) were unilateral, and three (80%) bilateral, formance. totaling 27 involved limbs. In all participants, the involved limb The main inclusion criteria were people with the upper limb was on the dominant side. compressive syndrome, but only those with a CTS diagnosis Figure 1 shows the key implications concerning the symptoms were selected. The following criteria were also respected: age bet- and other conditions caused by CTS, as absolute frequency. ween 18 and 59 years complete, both genders, since they are The main symptoms reported by all participants (100%) considered the young-adult audience where there is a higher in- were pain - the key complaint of all of them - as well as pa- cidence of CTS, and be a patient of the orthopedics outpatient resthesia - numbness (100%), and tingling (100%). Other clinic in the mentioned specialties. People with impaired body conditions present in most of the participants (93.3%) were functions such as general and specific mental functions, sensory changes in sensitivity, usually hypoesthesia, that is the de- functions, especially sight, hearing and vestibular; and speech crease or loss of sensitivity, in addition to muscle weakness functions were excluded. These functions were selected due to in the hand, especially in the site of innervation of the me- the difficulty or impossibility in communication to collect the dian nerve. The less reported sign was edema, present only data. Also, people with a previous clinical history of any kind in six participants (40%). 235 BrJP. São Paulo, 2020 jul-sep;3(3):234-8 Estivalet KM, Thomas C, Ponte AS, Pinto DS and Delboni MC

It was observed that pain in the upper limb, when performing a specific activity, follows the several conditions concerning CTS, being reported as extreme by 86.7% of the participants. Diffi- culty to sleep, represented by sleep alterations, was reported by all participants, and of extreme difficulty for most of them (86.7%) and very difficult for the remaining participants (13.3%).

Absolute frequency There was also the prevalence of muscle weakness in the upper limb, especially the hand, in 12 participants (80%), in addition Pain Edema Tingling Burning to the extreme difficulty in moving the limb by 11 participants Numbness Weakness (73.3%). Such information is important due to the possibility of interference in the performance of occupational activities due to Changes in sensitivity the motor and sensory impairment caused by CTS. Skin discomfort, reported as a pinpricking sensation, is present in 66.7% of the participants with extreme intensity, but among the variables, Figure 1. Absolute frequency of the symptoms and other conditions of the Carpal Tunnel syndrome (n=15) it is the symptom with less complaint. DISCUSSION The intensity of pain was also addressed - mild, moderate, severe, and very severe, as well as the time of occurrence - night, day, and In most of the cases, the CTS etiology is idiopathic, but there upon waking (Table 1). are situations of secondary order as continent and content ab- As we can see, the level of pain was moderate and/or severe. Pain normalities, dynamic abnormalities such as labor pathologies, is more frequent at night, considered an severe pain by all par- and acute as in the case of trauma6. When talking about CTS, ticipants. much is said about its incidence considering gender and age. In Besides the identification of activities that participants face dif- this study, females and adults are predominant, and the highest ficulty or can not perform, DASH also allows addressing the peak between 45 and 59 years (75% of females) and the second severity of pain and other symptoms, such as the difficulty in between 75 and 84 years (64% females)1, even with the possi- moving the upper limb and sleep. Figure 2 shows the level of bility of interrupting the professional career7. The meta-analysis severity, not only of pain but of other symptoms and conditions conducted with 87 studies4 showed the high incidence of CTS caused by CTS and referred to as of extreme intensity (5) and where females are the most affected by the disease, indicating high intensity (4). that in most of the epidemiologic studies, the highest prevalence of CTS is in the female population8. Another study with 386 Table 1. Intensity and moment of the pain (n=15) people with CTS, 322 were female (83%), and 64 were male (17%), with an average age of 57 years (30 to 81 years range)9. Level of pain During the day Upon waking During the night in the hand number of number of number of It is known that the bilateral involvement is the most common participants participants participants in CTS, more than 50% of the cases, and the dominant hand is (n and %) (n and %) (n and %) usually the first and most severely involved10. It is worth noticing Severe 07 (46.7) 08 53.3) 15 (100) that in this study, the most involved hand was also the dominant Moderate 07 (46.7) 06 (40.1) 0 hand, the right hand being the one. However, there is also the Mild 01 (6.6) 01 (6.6) 0 possibility of unilateral symptoms in 75% of the cases where the 11 Total general 15 (100) 15 (100) 15 (100) left side was involved in 54.8% of the cases . So, it is worth mentioning that the bilateral characteristic increases with the duration of the symptoms6. Data on age and the dominant side are critical for an initial assessment, as well as the dimension and treatment plan7. However, biopsychosocial aspects should also be taken in consideration since women are more prone to have CTS, and the incidence of the disease increases more linearly with age and the body mass index than in relation to the other factors; not to mention the risk of CTS due to stressing tasks, where the social support is Pain Discomfort Weakness Difficulty Sleep considered a protecting factor6. in moving alterations In general, the CTS clinical picture includes complaints about the limb pain when in forced flexion and extension position; or paresthe- Extreme intensity Great intensity sia such as numbness and tingling through the median nerve tra- Figure 2. Identification of the relationship of pain and other condi- jectory, worsening at night, the presence of at least one positive 11 tions in the upper limb by the Disabilities of the Arm, Shoulder and clinical test or evidence of atrophy in the thenar region . There Hand (n=15) are also cases with edema3. 236 Interference of the Carpal Tunnel syndrome BrJP. São Paulo, 2020 jul-sep;3(3):234-8 symptoms on occupational performance

In the early stage of the compressive syndrome, the symptom is therapist (OT) in the view of the Biomechanical Model are primarily at night due to the increase of the intratunnel pressu- some directions to control the edema and pain at the surgery re that can occur for several reasons, among them the tendency site, and the care not to have scar adhesion, as well as exercises to flexion the wrist and the increase in blood pressure during to slide the tendon and nerve, and eventual muscle strengthe- the second half of the night1. ning that are also post-surgical care17. Therefore, it is up to According to the study, pain is related to paresthesia, mentio- the OT to develop the intervention by the rehab of the upper ned as a burning and tingling sensation. One study compared limb using the knowledge on anatomy and biomechanics, and the distribution of the pain throughout the involved upper based on the Human Occupation Model, to help to acquire limb and, according to the study, 21% of the patients repor- the skills, performance patterns, and occupation3. ted paresthesia and pain in the forearm; 13% in the elbow; Whenever the occupational performance is impaired, the OT 7.5% in the arm; 6.3% in the shoulder; and 0.6% in the neck should intervene with preventive measures to promote health, region12. Therefore, pain can have proximal irradiation to the and measures focusing on rehab to prevent the worsening of arm and shoulder6. the clinical picture3,19. The preventive work of the Occupa- Pain was the main symptom reported. Since the pain was tional Therapy can provide guidance concerning household moderate during the day or very severe at night, it was con- and daily activities, adapting the way of doing them, aiming sidered of high frequency in the general population, being at improving the quality of life and preventing the worsening the most common symptom11. It is most usual at night, even of the symptoms17 with a positive effect on results of the lon- awaking the person13. A study about the impact of CTS on g-term conservative treatment19. sleep quality confirmed the correlation of sleep disorders The size of the sample was a limitation of the study. Other and people with CTS with a significant reduction in sleep studies are necessary, with larger samples and the possibility duration – about 2.5 hours less than the recommended – to discuss the implications of CTS on occupational perfor- running the risk of comorbidities14. So, it was realized that mance; relate CTS with other diseases in the upper limbs; use pain interferes with sleeping, whether preventing the person the randomized clinical trial methodology to assess the pain from falling asleep or waking up at night because of the situation and paresthesia, and the treatment possibilities of pain7. Among the symptoms identified in the study, pain people with CTS. is the most frequent, especially at night, and it is the main complaint of the participants. CONCLUSION Some occupational factors, especially in labor activities, are considered a risk to trigger CTS, such as repetitive move- CTS can impair occupational performance, especially in acti- ments of the flexor digitorum (tendons that pass with the ner- vities involving the upper limbs. The main complaint is pain, ve in the carpal tunnel), exposure to vibration and increase in which can be very severe, usually at night, affecting sleep and manual force15,16, in addition to inadequate posture for long occupational activities. Besides pain, paresthesia also interferes periods; invariability in tasks; mechanic pressure on certain with occupational performance. parts of the body, in particular, the upper limbs; static muscle work; shocks and impact; cold; and organizational and REFERENCES psychosocial factors6. Moreover, with the loss of sensation 1. Chammas M, Boretto J, Burmann LM, Ramos RM, dos Santos Neto NF, Silva JB. in the fingers, it is possible to face difficulties in performing Síndrome do túnel do carpo – Parte I (anatomia, fisiologia, etiologia e diagnóstico). simple daily activities, as grasping an object7. So, it is im- Rev Bras Ortop. 2014;49(5):429-36. 2. Ibrahim I, Khan WS, Goddard N, Smitham P. 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238 BrJP. São Paulo, 2020 jul-sep;3(3):239-44 ORIGINAL ARTICLE

Intensity of pain, disability and psychosocial factors in women with chronic pelvic pain: cross-sectional study Intensidade da dor, incapacidade funcional e fatores psicossociais em mulheres com dor pélvica crônica: um estudo transversal

Jennifer Nogueira Rocha1, Luiz Eduardo de Castro1, Virgínia Martello Riccobene1, Michele Souza Menezes Autran2, Leandro Alberto Calazans Nogueira2,3, Felipe José Jandre dos Reis3,4

DOI 10.5935/2595-0118.20200177

ABSTRACT CONCLUSION: Women with chronic pelvic pain had moderate levels of pain intensity and disability. The psychosocial factors BACKGROUND AND OBJECTIVES: Chronic pelvic pain with the highest mean score were anxiety and stress. The inten- can be considered one of the main causes of morbidity and func- sity of pain and disability were correlated with each other and tional disability in women. The influence of psychosocial factors with kinesiophobia. on chronic pelvic pain has been little explored in the literature. Keywords: Chronic pain, Pelvic pain, Psychosocial impact. This study sought to characterize the profile of chronic pelvic pain in women, the presence of psychosocial factors and the as- RESUMO sociation with pain and disability. METHODS: This cross-sectional study included women with JUSTIFICATIVA E OBJETIVOS: A dor pélvica crônica pode chronic pelvic pain. Data on pain, disability and psychosocial ser considerada uma das principais causas de morbidade e in- factors was collected using specific questionnaires. Analysis of capacidade funcional para as mulheres. A influência dos fatores frequency, central tendency and dispersion were presented. Pear- psicossociais na dor pélvica crônica foi pouco explorada na lite- son’s correlation test was used to verify the correlation between ratura. O objetivo deste estudo foi caracterizar o perfil da dor pain, disability and psychosocial factors. The statistical signifi- pélvica crônica em mulheres, bem como buscar a presença de cance was set as alpha=95%. fatores psicossociais e a associação com dor e incapacidade. RESULTS: The study consisted of 25 women, with a mean age MÉTODOS: Estudo transversal que incluiu mulheres com dor pél- of 45.4 years. The mean pain intensity at the time of the asses- vica crônica. Os dados referentes da dor, incapacidade e os fatores sment was 4.76±3.39. The mean disability was 4.01±2.32. An- psicossociais foram coletados utilizando questionários específicos. xiety presented a mean of 7.16±3.36 and stress 7.04±3.16. The Foram apresentadas as análises de frequência, tendência central e level of disability had a negative correlation with pain intensity dispersão dos dados. O teste de correlação de Pearson foi utilizado (r = -0.474; p=0.017), with the pain severity domain (r=-0.566; para se verificar a correlação entre dor, incapacidade e fatores psicos- p=0.003) and with kinesiophobia (r = -0.550; p=0.001). sociais. O valor de significância estatística adotado foi de alfa=95%. RESULTADOS: O estudo foi composto por 25 mulheres, com média de idade de 45,4 anos. A intensidade de dor média no mo- Jennifer Nogueira Rocha – https://orcid.org/0000-0003-3953-2816; mento da avaliação foi de 4,76±3,39. A média de incapacidade Luiz Eduardo Castro – https://orcid.org/0000-0001-6124-9588; Virgínia Martello Riccobene – https://orcid.org/0000-0001-6073-5058; foi de 4,01±2,32. A ansiedade apresentou média de 7,16±3,36 e Michele Souza Menezes Autran – https://orcid.org/0000-0002-8300-428X; estresse 7,04±3,16. O nível de limitação funcional teve correla- Leandro Alberto Calazans Nogueira – https://orcid.org/0000-0002-0177-9816; Felipe José Jandre dos Reis – https://orcid.org/0000-0002-9471-1174. ção negativa com a intensidade da dor (r= -0,474; p=0,017), com o domínio gravidade da dor (r=-0,566; p=0,003) e com cinesio- 1. Universidade Federal do Estado do Rio de Janeiro, Hospital Universitário Gaffrée e Guin- fobia (r= -0,550; p=0,001). le, Rio de Janeiro, RJ, Brasil. 2. Centro Universitário Augusto Motta, Programa de Pós-Graduação em Ciências da Re- CONCLUSÃO: As mulheres com doença pélvica crônica abilitação, Rio de Janeiro, RJ, Brasil. apresentaram níveis moderados de intensidade de dor e limi- 3. Instituto Federal do Rio de Janeiro, Curso de Fisioterapia, Rio de Janeiro, RJ, Brasil. 4. Universidade Federal do Rio de Janeiro, Programa de Pós-Graduação em Clínica Médica, tação funcional. Os fatores psicossociais com maior pontua- Laboratório de Psiconeurofisiologia, Rio de Janeiro, RJ, Brasil. ção média foram a ansiedade e estresse. A intensidade de dor e

Submitted on March 2, 2020. o nível de limitação funcional estiveram correlacionados entre Accepted for publication on May 29, 2020. si e com a cinesiofobia. Conflict of interests: none – Sponsoring sources: none. Descritores: Dor crônica, Dor pélvica, Impacto psicossocial. Correspondence to: Felipe Reis INTRODUCTION Instituto Federal do Rio de Janeiro, Campus Realengo Rua Carlos Wenceslau, 343 – Realengo 21715-000 Rio de Janeiro, RJ, Brasil. Chronic pelvic pain (CPP) is the chronic or persistent pain E-mail: [email protected] observed in the structures related to the men or women’s pel- © Sociedade Brasileira para o Estudo da Dor vis, frequently associated with cognitive, behavioral, sexual 239 BrJP. São Paulo, 2020 jul-sep;3(3):239-44 Rocha JN, Castro LE, Riccobene VM, Autran MS, Nogueira LA and Reis FJ and negative emotional consequences, as well as suggestive and perineum, on most days for at least 6 months, selected symptoms of the inferior urinary tract, sexual organs, intesti- by convenience according to the schedule of appointments in ne, pelvic floor or gynecological disorder1. Like in other chro- these clinics, were included. Women with history or diagnosis nic pain scenarios, CPP may be associated with cognitive, of neoplasia, neurological diseases of the central nervous system behavioral, sexual, and negative emotional consequences2. Al- and cognitive deficit were not eligible for the study. though CPP may have a gynecological, gastrointestinal, uro- For the evaluation of sociodemographics and general aspects logic, or musculoskeletal origin, most cases don’t present one of pain, the Questionnaire for Chronic Pelvic Pain Assessment determined cause3. Pelvic pain can be considered one of the (QCPPA) from the International Pelvic Pain Society (IPPS) main causes of morbidity and functional disability for women previously translated and validated into Portuguese19 was used. and can interfere with daily life activities and lead to the need QCPPA presents sociodemographic questions about work, of health services4. It’s estimated that about 3.8% of women professional history, age, marital status, home cohabitants and at any age and 12% of women at reproductive age complain education level. It also evaluates the pain, menstrual, urinary, about sensations of pain in the pelvic region5,6, in addition gastrointestinal, emotional, surgical, or obstetric antecedents, to about 18% leaving work at least one day every year due to the occurrence of physical, psychological, or sexual violence, pelvic pain7,8. Data from a survey in the United States that among other questions. QCPPA was applied except for the included 773 women with CPP identified that approximately matters of drugs, professional help and physical examination; a quarter of them needed rest for 2.5 days per month and also, in the pain map section, only the item concerning peri- close to 25% presented dysfunction or dyspareunia, and the neal and vulvar pain was used. direct and indirect costs of productivity loss were estimated at Next, for the assessment of pain, the Brief Pain Inventory approximately 3 billion dollars7. (BPI) was used, which is a multidimensional instrument that Besides the primary health conditions characterized by pel- evaluates pain intensity and its interference with general acti- vic pain, several mechanisms and structures may be involved vities, mood, motion, work, relationships with other people, in CPP, including the upper genital tract, muscles and fascia sleep and fun based on an 11-point scale ranging from zero (no of the abdominal wall and pelvic floor, bladder, ureters and pain/no interference) to 10 (pain as severe as possible). Scores gastrointestinal tract8,9. The clinical approach focused only on for both dimensions range from zero to 10 and are calculated biological aspects may increase the use of health care and diag- using the average of the total items. High scores represent high nostic tests, in addition to more situations in which surgical pain intensity or high pain interference in general activities20. procedures or hospitalizations for pain treatment are propo- In order to characterize the most frequent pain descriptors, the sed3. It’s important that, besides biological factors, the influen- McGill questionnaire was used, which allows the patient to ce of cognitive, emotional, environmental and social factors on portray their experience of pain in more detail21. the experience of pain is considered10,11. It’s also necessary to Disability was assessed through the Patient Specific Functio- recognize that neurophysiological mechanisms such as periphe- nality Scale (PSFS). The patient is asked to identify up to ral sensitization, central sensitization and neuroplastic modi- three activities that he/she considers unable to perform or fications in various regions of the brain can contribute to the that present some difficulty. The measurement is done by chronification, maintenance and evolution of CPP12-14. 11 points Likert scales for each activity, and the higher the A great challenge for the clinical practice is to identify the average score, ranging from zero to 10 points, the better the interaction between psychological, behavioral and social fac- patient’s ability to perform the activities22. The PSFS is a sel- tors, as well as their contributions to the experience of pain. f-administered questionnaire, it’s validated and widely used Numerous studies demonstrated the influence of psychologi- in several musculoskeletal conditions, with reproducibility of cal factors in the development, persistence and treatment of 0.85 (ICC 0.77-0.90)23. chronic pain15-17. The evaluation of pain-related psychosocial factors was perfor- This study’s objective was to describe the profile of CPP in wo- med by the Brief Screening Questionnaire (BSQ), which covers men, regarding the location and intensity, the level of disability the presence of symptoms of depression, social isolation, an- and association with psychosocial factors xiety, stress, kinesiophobia and catastrophism24. The tool com- prises nine items, being one for anxiety, two for kinesiophobia, METHODS one for stress, one for social isolation, two for catastrophism and two for depression24,25. The answers are graded from zero A cross-sectional observational study, which followed the re- and 10, and the higher the answer value, the worse is the out- commendations of the Strengthening the Reporting of Ob- come. Zero represents “I never do this” or “not at all”, increa- servational Studies in Epidemiology (STROBE)18. Data was sing up to 10, which represents “I always do this” or “quite a collected from September 2019 to January 2020 in the gyneco- lot”24. The tool uses brief questions for the specific scales for logy outpatient clinic of one hospital and pelvic physiotherapy each of the psychosocial items previously validated for Brazil. outpatient clinic of another hospital, both from the urban area The research protocol was previously submitted to and appro- of Rio de Janeiro. ved by the HUGG Ethics and Research Committee (CAAE: Women over 18 years old with pain in the pelvis, lower abdo- 17465419.0.0000.5258) and all participants signed the Free men, lumbar region, medial aspect of the thigh, inguinal area and Informed Consent Term (FICT). 240 Intensity of pain, disability and psychosocial factors in BrJP. São Paulo, 2020 jul-sep;3(3):239-44 women with chronic pelvic pain: cross-sectional study

Statistical analysis Table 1. Clinical characteristics of the sample The data was presented and coded using Microsoft Office Excel, Variables n (%) 2013 Windows version, and analyzed using Statistical Package Drugs for Social Science (SPSS), version 20 for Mac. The Kolmogo- Analgesics 18 (72) rov-Smirnov test was used to check the normal distribution of Opioids 10 (40) the variables. Frequency, central tendency (mean or median) and Non-hormonal anti-inflammatories 10 (40) dispersion (standard deviation) analyses were presented according to the analyses of data normality. The association between Hormonal anti-inflammatories 1 (4) pain intensity, disability and psychological variables was perfor- Anticonvulsants 6 (24) med using the Pearson correlation test. The statistical significan- Antidepressants 5 (20) ce value adopted for all analyses was p<0.05. Muscle relaxer 3 (12) Adrenergic receptor agonist 1 (4) RESULTS Antiflatulent 1 (4) Hormonal 1 (4) Twenty-five women were included, with a mean age of 45.4±10.8 Surgeries years old: xmin=30 to xmax=72. Regarding the other characteristics of the sample, 11 (44%) had completed high school, 11 Yes 9 (36) (44%) were married, 21 (84%) were non-smokers, 18 (72%) No 16 (64) didn’t drink alcohol, and 19 (76%) were sedentary. As for the Comorbidities obstetric history, 20 (80%) had already become pregnant, 9 Urinary symptoms 15 (60) (36%) reported having had at least one abortion, and 10 (40%) Irritable bowel syndrome 14 (56) had two children. Considering the characteristics related to Pelvic congestion syndrome 10 (40) work, 14 (56%) were in economically active age and 8 (32%) Migraine 8 (44) were away from work due to presence of pain. As for the clinical characteristics, all participants used more than Depression 8 (32) one drug for pain, including several classes of drugs. Among the Endometriosis 6 (24) studied sample, 18 (72%) used analgesics, 10 (40%) opioids, 10 Adenomyosis 1 (4) (40%) non-hormonal anti-inflammatories, 6 (24%) anticonvul- Fibromyalgia 1 (4) sants, 5 (20%) antidepressants, 3 (12%) muscle relaxers and 1 Sexual abuse (4%) hormonal anti-inflammatories, hormonal drug, adrenergic Yes 5 (20) receptor agonist and antiflatulent. Regarding surgeries, 9 (36%) No 20 (80) had carried out some type of procedure related to CPP. In relation to the comorbidities commonly associated with CPP, it Psychological and/or physical abuse was found that 8 (32%) presented depression, 15 (60%) uri- Yes 15 (60) nary symptoms, 14 (56%) irritable bowel syndrome, 11 (44%) No 10 (40) migraine, 10 (40%) symptoms of pelvic congestion syndrome, 6 (24%) diagnosis of endometriosis and 1 (4%) presented fibromyalgia and adenomyosis. From the total, 5 (20%) reported Headache – 68% having suffered some form of sexual abuse and 15 (60%) suffered Upper limbs some form of psychological and/or physical abuse in childhood pain – 36% and/or adult life. As for coping strategies, 19 (76%) women sho- Supraumbilical pain – 28% Lumbar pain – 84% wed a passive and negative strategy in relation to pain, such as resting and assuming pelvic pain as the main problem in life. The lnfraumbilical pain – 68% Buttocks/hip/ clinical characteristics are grouped in table 1. pubis/inguinal In the representation of the body map described by BPI, iden- Vulvar/perineal pain – 72% pain – 76% tifying the areas affected by pain, there was greater presence of Pain in the lower lumbar pain (84%), vulvar/perineal pain (76%), followed by limbs – 72% pain in the buttocks/hip/pubis/inguinal region and pain in the lower limbs, both with 72% (Figure 1). Figure 1. Body map representing the frequency of the location of pain in the sample The pain intensity reported at the moment of evaluation presented a mean of 4.76±3.39; xmin=zero to xmax=10. When descri- bing the characteristics of pain, the most used McGill descrip- the results of BPI, the mean for the domain of pain severity was tors were “heavy” and “sensitive”. The mean time of pain was 5.70±2.07; xmin=1.50 to xmax=9.00 and the mean for the do- 79.36±61.6 months; xmin=6 to xmax=216. main of pain impact was 6.69±2.22; xmin=2.85 to xmax=10.0. Through the evaluation of disability by PSFS the participants Regarding the psychosocial factors evaluated by BSQ, an- had a mean score of 4.01±2.32; xmin=0 to xmax=8.6. Regarding xiety presented a mean of 7.16±3.36; xmin=zero to xmax=10, 241 BrJP. São Paulo, 2020 jul-sep;3(3):239-44 Rocha JN, Castro LE, Riccobene VM, Autran MS, Nogueira LA and Reis FJ social isolation 4.12±4.05; xmin=zero to xmax=10, stress psychosocial factors, anxiety and stress had the highest ave- 7.04±3.16; xmin=zero to xmax=10, catastrophism 6.0±3.81; rages, followed by catastrophism, social isolation, depres- xmin=zero to xmax=10), depression 5.72±3.96; xmin=zero sion and kinesophobia. The intensity of pain and the degree to xmax=10 and kinesiophobia 3.94±4.36; xmin=zero to of disability were correlated with each other and with kine- xmax=10. The results of pain evaluation and psychosocial sophobia. measures are shown in table 2. The values of pain intensity assessed in the present study can be considered moderate26, resembling other studies with Table 2. Mean and standard deviation for pain-related and psycho- people with CPP27-29. In a study conducted in Brazil with metric measurements 91 women, pain intensity varied according to body mass Variables Mean (SD) from 2.66 to 3.1528. In another study conducted in Norway, BPI (zero/10) 108 women with CPP participated and the average pain in- Pain intensity (at the moment) 4.76 (33.9) tensity assessed was 4,230. The moderate pain intensity ob- Pain severity 5.7 (2.07) served may justify the use of different analgesic methods Pain impact 6.69 (2.22) reported by the participants. Time of pain (months) 79.36 (61.6) The widespread pain characteristic on this sample may be suggestive of the involvement of central sensitization mechanisms31,32. Disability (zero/10) 4.01 (2.32) The absence of correlation between the location of pain and inju- BSQ (zero/10) ries in patients with CPP was already observed in another study33. Anxiety 7.16 (3.36) It’s possible that peripheral and central sensitization mechanisms Stress 7.04 (3.16) may partially explain this clinical scenario34. However, in order Catastrophism 6.0 (6.81) to confirm this hypothesis, other tests need to be performed, 35 Social isolation 4.12 (4.05) such as the application of the central sensitization inventory . Depression 5.72 (3.96) Although a clinical evaluation tool for central sensitization in the context of CPP has already been elaborated, its psychome- Kinesiophobia 3.94 (4.36) tric validation and cut-off points still need to be established36. BPI = Brief Pain Inventory; BSQ = Brief Screening Questionnaire; SD = standard deviation The levels of disability found in the study may be influenced by several factors, such as, for example, concerns, fears and possible The level of functional limitation had a negative correlation with incorrect explanations related to the cause of pelvic pain37. The pain intensity (r=-0.474; p=0.017), with the domain of pain se- lower education level also presents a reverse relation to CPP, sin- verity (r= -0.566; p=0.003) and with the kinesiophobia mean ce women with lower education have more severe pain, suffering, (r=-0.550; p=0.001). The pain intensity presented correlation concerns, and degree of disability38. with the BPI domain of pain severity (r=-0.53; p=0.006). For the Considering the investigated psychosocial factors, anxiety other psychometric variables there was no statistically significant and stress were those with higher averages. Previous studies correlation. The data is shown in table 3. have reported a high prevalence of anxiety in women with CPP, reaching 63% of the sample in a study also conducted Table 3. Correlation between psychological variables, intensity of pain in Brazil39. In general, the high prevalence of anxiety is also and disability accompanied by depression in people with CPP40,41. In ano- Variables Disability Pain intensity ther study, also conducted in Brazil, 73% of women with r (p-value) r (p-value) CPP presented anxiety and 40% depression41. In the United Disability - -0.474 (0.017) States, a study including 107 women with CPP identified a Pain intensity -0.474 (0.017) - prevalence of 38.6% of anxiety and 25.7% of depression42. Pain severity -0.566 (0.003) 0.812 (<0.001) These prevalence values can be considered high when com- Pain impact -0.164 (0.433) -0.027 (0.896) pared to the overall prevalence of anxiety in women, whi- Anxiety 0.101 (0.630) -0.040 (0.848) ch is 4.6% (9.3% in Brazil) and depression, which is 5.1% (5.8% in Brazil)43. The average values for symptoms of de- Social isolation -0.255 (0.220) 0.008 (0.969) pression observed in the participants was considered one of Stress 0.049 (0.818) 0.137 (0.515) the lowest in relation to the other variables. Although two Catastrophism -0.106 (0.615) 0.010 (0.963) questions that presented validation when compared to the Depression -0.132 (0.531) -0.093 (0.657) Beck Depression Inventory (BDI)25 were used, this differen- Kinesiophobia -0.550 (0.004) 0.458 (0.021) ce with the literature findings may be related to the different The values in bold correspond to statistically significant correlation. tools used in the other studies. Stress was the second major observed mean. Pain and stress are two distinct and overlaid DISCUSSION processes, presenting multiple conceptual and physiological overlays. Any factor, be it physical, psychosocial, or emo- It was possible to identify that women with CPP presented tional capable of challenging homeostasis can be considered moderate levels of pain intensity and disability. Regarding as a stressful element44. Thus, several factors may be consi- 242 Intensity of pain, disability and psychosocial factors in BrJP. 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244 BrJP. São Paulo, 2020 jul-sep;3(3):245-8 ORIGINAL ARTICLE

Recording acute pain in hospitalized patients O registro da dor aguda em pacientes hospitalizados

Amanda Brassaroto Gimenes1, Camila Takáo Lopes2, Alfredo José Alves Rodrigues-Neto3, Marina de Góes Salvetti4

DOI 10.5935/2595-0118.20200178

ABSTRACT Keywords: Acute pain, Health services, Nursing, Nursing diagnosis, Pain management. BACKGROUND AND OBJECTIVES: Nurses are in a good position to carry out pain assessment and management, as well RESUMO as to perform pharmacological and non-pharmacological interventions. The aim of this study was to compare hospital pain JUSTIFICATIVA E OBJETIVOS: Os enfermeiros têm posição records in hospitalized patients with pain reports from a previous privilegiada para realizar a avaliação e o manejo da dor e utili- study and to analyze the presence of the “Acute Pain” Nursing zam intervenções farmacológicas e não farmacológicas. O obje- Diagnosis and the Nursing Interventions prescribed for pain ma- tivo deste estudo foi comparar os registros hospitalares de dor nagement. em pacientes internados com relato álgico em estudo prévio e METHODS: Cross-sectional study with retrospective data col- analisar a presença do Diagnóstico de Enfermagem “Dor Aguda” lection. As a criteria for sample selection, the pain report referred e as Intervenções e Atividades de Enfermagem prescritas para o to in a previous study interview was used. The medical records manejo da dor. were analyzed in order to verify the registries of acute pain inten- MÉTODOS: Estudo transversal com coleta de dados retrospec- sity, presence of the “Acute Pain” Nursing Diagnosis and nursing tiva. Utilizou-se como critério de seleção da amostra o relato de interventions prescribed for adult hospitalized patients. dor referida em entrevista de estudo anterior. Foram analisados RESULTS: The sample of the present study consisted of 63 adult os prontuários com a finalidade de verificar os registros de inten- patients, with a mean hospital stay of 12 days. There was a dispa- sidade de dor aguda, presença do Diagnóstico de Enfermagem rity between medical records and pain data collected previously, “Dor Aguda” e cuidados de enfermagem prescritos para pacien- indicating pain underreporting. The “Acute Pain” Nursing Diag- tes adultos internados. nosis was identified in 60.3% of cases and Nursing Interventions RESULTADOS: A amostra do presente estudo consistiu em 63 were based on pharmacological pain relief (36.5%). pacientes adultos, com tempo médio de internação de 12 dias. Ob- CONCLUSION: The information in the hospital’s medical servou-se disparidade entre registros de prontuário e dados sobre records did not reflect the pain reports observed in a previous a dor coletados previamente, indicando subnotificação da dor. O study. There was underreporting of pain and the Nursing Inter- Diagnóstico de Enfermagem “Dor Aguda” foi identificado em ventions listed by nurses privileged the assessment and pharma- 60,3% dos casos e as Intervenções e Atividades de Enfermagem cological treatment of pain. These findings suggest the need for foram pautadas no alívio farmacológico da dor (36,5%). continuous training of the Nursing Team with an emphasis on CONCLUSÃO: Os registros de dor no prontuário do hospital non-pharmacological pain assessment and management. não refletiram os relatos de dor observados em estudo prévio. Foi verificada a subnotificação da dor e as Intervenções e Ativi- dades de Enfermagem elencadas pelos enfermeiros privilegiaram Amanda Brassaroto Gimenes – https://orcid.org/0000-0002-1515-5844; Camila Takáo Lopes – https://orcid.org/0000-0002-6243-6497; a avaliação e o tratamento farmacológico da dor. Esses achados Alfredo José Alves Rodrigues-Neto – https://orcid.org/0000-0002-5376-7075; sugerem a necessidade de treinamento contínuo da Equipe da Marina de Góes Salvetti – https://orcid.org/0000-0002-4274-8709. Enfermagem com ênfase na avaliação e manejo não farmacoló- 1. Universidade de São Paulo, Hospital Universitário, Residente de Enfermagem do Pro- gico da dor. grama de Saúde do Adulto e do Idoso, São Paulo, SP, Brasil. Descritores: Diagnóstico de enfermagem, Dor aguda, Enferma- 2. Universidade Federal de São Paulo, Escola Paulista de Enfermagem, Departamento de Enfermagem Clínica e Cirúrgica, São Paulo, SP, Brasil. gem, Manejo da dor, Serviços de saúde. 3. Universidade de São Paulo, Faculdade de Ciências Farmacêuticas, São Paulo, SP, Brasil. 4. Universidade de São Paulo, Escola de Enfermagem, Departamento de Enfermagem Médi- INTRODUCTION co-Cirúrgica, São Paulo, SP, Brasil.

Submitted on March 8, 2020. During hospitalization, pain affects various physiological and me- Accepted for publication on June 17, 2020. 1,2 Conflict of interests: none – Sponsoring sources: none. tabolic functions , increases the risk of complications and stunts the patient’s recovery. When undertreated, acute pain may become Correspondence to: Av. Dr. Enéas Carvalho de Aguiar, 419 - Cerqueira César chronic, resulting in a financial and social burden for patient and so- 05403-000 São Paulo, SP, Brasil. ciety3. Nurses are in a good position to carry out pain assessment and E-mail: [email protected] management, as well as to perform pharmacological and non-phar- © Sociedade Brasileira para o Estudo da Dor macological interventions. According to the NANDA-I Nursing 245 BrJP. São Paulo, 2020 jul-sep;3(3):245-8 Gimenes AB, Lopes CT, Rodrigues-Neto AJ and Salvetti MG

Diagnostics Classification, “Acute Pain” is defined as: ‘’Unpleasant mode (yes/ no) regarding several activities. Data of the current sensory and emotional experience associated with actual or potential work was collected retrospectively and transversally, using the ins- tissue damage or described in terms of such damage (International trument developed for this purpose. The authorization for access Association for the Study of Pain); sudden or slow onset of any to the physical records of the 63 patients was obtained, collecting intensity from mild to severe with an anticipated or predictable end sociodemographic (age and sex) and clinical information. The in- and a duration of less than 3 months”2. Relief of pain is the patient’s formation on pain was extracted from the values documented on right and is an ethical responsibility of the professional committed the vital signs print and ND forms selected by the nurses after with humanization and quality of assitance4. analysis of the NI on the days related to the collection of data Identifying the complaint of pain and the consequences of acute from the main study. The mean pain intensity was calculated for pain for the patient’s recovery should be a nurse’s concern. Kno- the morning, afternoon and night, being classified as: mild (1-4), wledge gaps on pain assessment and management and the lack moderate (5-7) or severe (8-10)12. of systematization of this care contributes to underreporting and The presence of the “Acute Pain” ND and the proposed Acu- inadequate treatment, despite the various assessment and mana- te Pain-NI for pain control were evaluated. Coherent conducts gement tools available5-10. were considered to be the records containing: the ND-NI related A literature review that analyzed studies on the recording of post to pain management. Incoherent nursing behaviors were consi- surgery pain in the hospital context showed that the quality of dered the records containing: NI related to pain control without nurse records about pain are insufficient, affect the clinic deci- the presence of “Acute Pain” ND and absence of ND and NI sion making and undermine the continuity of care11. related to pain management in patients that reported pain. This study aimed at exploring the registries of pain in the medi- This study was approved by the Ethics Committees of the Nu- cal record, the clinical practice of the Nurse Team in regard to rsing School of the Universidade de São Paulo (opinion number the management of pain. 2,542,888) and the USP University Hospital (opinion number Thus, this study’s objectives were to compare the pain records of 2,611,208). hospitalized patients that presented pain in a previous study and analyze the relation between the ‘’Acute Pain’’ Nurse Diagnosis Statistical analysis (ND) and the Nurse Interventions (NI) prescribed for the ma- The data was tabulated in a spreadsheet and analyzed in a statis- nagement of pain. tics software (SPSS 25.0). A descriptive analysis was performed, containing the characteristics of the sample, the registry of the METHODS “Acute Pain” ND in the medical record and the Nursing Inter- ventions prescribed for this Diagnosis. The results of pain inten- The study was done in a large scale University Hospital located in sity in the main study were compared with the means collected the west of the city of São Paulo. The place of research is a public in the current study. institution, providing secondary level health assistance and offering emergency, surgical, clinical and outpatient services. RESULTS This study is a ramification of the “Prevalência de dor e ade- quação analgésica: estudo diagnóstico” (“Prevalence of pain and The results are presented in three stages: sample description, analysis analgesic fitness: diagnostic study”) research, whose objective was of the pain registries in the hospital record in comparison to the main to identify the prevalence of pain and the adequacy of analge- study’s form and, lastly, the ND and NI for the referred patients. sia in hospitalized patients. The criteria for the sample selection The sample consisted of 63 patients who reported pain in the (n=134) of the referred study was: individuals with 18 years old main study. The patients had a mean length of hospitalization of or more, hospitalized in the University Hospital in November 11.9 days (median = 10 days, minimum = 1 day and maximum 2017, conscious, lucid, well oriented in time and space, and that = 57 days), were predominantly women (57.1%) and were bet- accepted in participating in the research after signing the Free ween 18 and 59 years old (65.1%). The places of hospitalization and Informed Consent Term (FICT). From the main research with more cases of pain were the Surgical Clinic (36.5%), Medi- database, the extracted sample (n=63) consisted of patients who cal Clinic (28.5%) and Adult Emergency Room (15.8%). reported pain at the time of the interview or in the 24 hou- The most frequent medical diagnosis, by specialty, were clinic rs preceding the main study interview, admitted to the Adult (30.2%), gastro-surgical (19.0%) and orthopedic (17.5%). Among Emergency Room, Adult Intensive Care Unit, Medical Clinic, the evaluated patients, 61.9% had comorbidities prior to their current Surgical Clinic, Obstetrics Clinic or Day Hospital. Study parti- hospitalization and, of these, 25.4% had three or more comorbidities. cipants were evaluated by means of a questionnaire developed for In the main study’s form, in which the intensity of pain was clas- the main study, including sociodemographic, clinical and pain sified as: light (1-4), moderated (5-7) or severe (8-10)12, 76.3% treatment data. of interviewed patients reported moderate or severe pain. In the The presence, intensity and impact of pain on activities were as- records of the vital sign prints there was no information about sessed. The presence of pain was assessed at the moment of the pain in 61.9% (n=39) of the cases and only 4.8% (n=3) presen- interview and in relation to 24h before the interview. The intensity ted moderate or severe pain (Table 1), demonstrating the diffe- of pain was assessed by the visual numeric scale (VNS)12 and the rence between the self-reported pain and the registry of pain in impact of pain on daily activities was assessed by the dichotomous the medical records. 246 Recording acute pain in hospitalized patients BrJP. São Paulo, 2020 jul-sep;3(3):245-8

Table 1. Comparison between pain intensity in medical records and neither NI for acute pain (Incoherent Diagnosis and Activities the pain reports from the previous study. São Paulo, 2018 II), as shown in figure 2. Intensity of pain Vital signs Main study print 100.0% n % n %

No pain 39 61.9 - - 80.0% Light pain (1-4) 21 33.3 14 23.7 Moderate pain (5-7) 2 3.1 22 37.3 60.0% Severe pain (8-10) 1 1.7 23 39.0 40.0% Total 63 100 59* 100 63.5% * There were 4 unexamined records in the main study due to lack of data. 20.0% 23.8% The comparison between the records of pain from the main 12.7% 0.0% study’s vital signs print and the data collection form are re- Coherent Diagnosis and Incoherent Diagnosis Incoherent Diagnosis presented in figure 1. It can be seen in the first column that, Activities and Activities I and Activities II among patients with a record of absence of pain in the vital Figure 2. Relationship between diagnoses and prescribed nurse in- signs form, 37.1% had reported severe pain in the main study. terventions. São Paulo, 2018 Likewise, in the ‘’moderate pain’’ column there is an absence of conformity to the records, since 50% of patients classified DISCUSSION with moderate pain in the hospital record referred severe pain in the main study. This study compared the records of hospitalized patients who had reported the presence of pain in the main study and analyzed 100.0% the consistency between the pain registries, the “Acute Pain” ND

80.0% 37.1% 38.1% and the NI prescription for pain management. 50.0% Discrepancies were found between the patients’ reports regar- 60.0% 100.0% ding the occurrence and intensity of pain and the registries made 34.3% 40.0% 47.6% by the Nursing Team in the medical records. Moreover, it was 50.0% 20.0% verified that in 23.8% of the cases there was no documentation 28.6% 14.3% of pain or prescription of pain management by nurses. 0.0% No Pain Mild Moderate Severe The incoherence between the pain registry in the records and the Vital signs print presence and intensity of pain identified in the main study shows Severe pain Moderate pain Mild pain incomplete registries and fragmented assistance processes, undermi- ning the quality and security of the service provided1. The Federal Figure 1. Columns show comparison between intensity registered in the medical records and in the previous study’s form. São Paulo, 2018 Nursing Council Resolution no. 429/2012 states the professionals’ responsibility and duty to register the information inherent to the 13 The “Acute Pain’’ ND was registered in 60.3% (n=38) of the care process, enabling the continuity and quality of assistance . analyzed records, however, the whole sample presented pain in The evaluation of pain as a fifth vital sign was instituted in order the main study1. For 33.3% (n=21) of the patients that presented to continuously identify its presence and establish appropriate 8-10,14 “Acute Pain’’ ND there was no registry of pain in the records. strategies for its control . In addition, the adoption of inter- Thus, the nurse may have register the “Acute Pain’’ ND not con- national standards, such as that established by the Joint Com- sidering just the presence of pain intensity in the vital signs print, mission International (JCI) in various health care organizations, but also the other characteristics and related features found in recognizes pain control as a practice to be followed for the hospi- 5 the ND2 definition. tal accreditation process . The most prescribed NIs were relief of pain through analgesics As for the presence of the registry of pain in the records, one stu- (36.5%); comprehensive pain assessment (19.0%) and moni- dy evaluating hospitalized patients in a secondary hospital obser- toring of the degree of discomfort or pain (17.5%), with clear ved lack of pain registry in 53,4% of assessed medical records7, a emphasis on pharmacological strategies rather than non-phar- slightly inferior number to the one observed in the present study, macological pain management measures. which found flaws in the pain record of 61,9% of patients. The It was observed that in 63.5% (n=40) of the cases the “Acute flaw in the records of pain supports the findings in the literature Pain” ND was associated with relevant NI for this Diagnosis that point to a lack of professional knowledge in regard to the (Coherent Diagnosis and Activities). In 12.7% (n=8) of the ca- evaluation and control of pain8,9,15. ses, the nurses prescribed a NI without registering the “Acute Despite the present study having evaluated only cases of patients Pain” ND (Incoherent Diagnosis and Activities I). Despite the that did report pain, the “Acute Pain’’ ND appeared in only 60,3% presence of pain referred by all the sample’s patients, in 23.8% of cases. This mismatch may have occurred due to failure in assessing (n=15) of cases the nurse did not registered “Acute Pain” ND, pain or because the nurses did not value the report of pain enough. 247 BrJP. São Paulo, 2020 jul-sep;3(3):245-8 Gimenes AB, Lopes CT, Rodrigues-Neto AJ and Salvetti MG

The documentation of the Nursing Process in the hospital whe- REFERENCES re the study was developed is computerized, performed through 1. Castro CC de, Pereira AKS, Bastos BR. Implementação da avaliação da dor como o a system of clinical reasoning support called “PROCEnf”. This quinto sinal vital. Rev Enferm UFPE online. 2018;12(11):3009-14. system makes it possible to follow the path from evaluation to 2. Herdman TH, Kamitsuru S. Diagnósticos de enfermagem da NANDA-I: definições e the planning of care16, making it possible to propose interventions classificação 2018-2020, 11ª ed. Porto Alegre: Artmed; 2018. 889-91p. 3. Ashmawi HA, Freire GM. Peripheral and central sensitization. Rev Dor. 2016;17(Su- related to pain, without necessarily having listed the “Acute Pain” ppl 1):31-4. ND. Thus, even if the “Acute Pain” ND was identified in 60.3% of 4. Lisboa LV, Lisboa JA, Sá KN. O alívio da dor como forma de legitimação dos direitos humanos. Rev Dor. 2016;17(1):57-60. the cases, pain care was prescribed in 76.2% of the cases. 5. Sousa-Muñoz RL, Rocha GE, Garcia BB, Maia AD. Prevalência de dor e adequação Pain relief with prescribed analgesics was the most frequent NI in da terapêutica analgésica em pacientes internados em um hospital universitário. Medi- cina. 2015;48(6):539-48. nursing care for acute pain management, referring to the analge- 6. Song W, Eaton LH, Gordon DB, Hoyle C, Doorenbos AZ. Evaluation of evidence- sic actions of the biomedical model9. Although this intervention -based nursing pain management practice. Pain Manag Nurs. 2015;16(4):456-63. 7. Cavalheiro JT, Ferreira GL, Souza MB, Ferreira AM. Intervenção de Enfermagem para is necessary for pain management, there are much less explored pacientes com dor aguda. Rev Enferm UFPE online. 2019;13(3):632-9. NI, such as massage, heat and cold application, relaxation tech- 8. Valério AF, Fernandes KS, Miranda G, Terra FS. Dificuldades enfrentadas pela enfer- niques and guided imagination, which may contribute to pain magem na aplicabilidade da dor como quinto sinal vital e os menismos/ações adota- dos: revisão integrativa. BrJP. 2019;2(1):67-71. 8 management and promotion of patient comfort . 9. Araujo LC, Romero B. Dor: avaliação do 5o sinal vital. Uma reflexão teórica. Rev Dor. This study has limitations, which should be pointed out: secon- 2015;16(4):291-6. 10. Nascimento LA, Kreling MCGD. Avaliação da dor como quinto sinal vital: opinião dary data and convenience sample analyses were used, factors de profissionais de enfermagem. Acta Paul Enferm. 2011;24(1):50-4. that make it difficult to generalize results. 11. Heikkilä K, Peltonen LM, Salanterä S. Postoperative pain documentation in a hospital setting: a topical review. Scand J Pain. 2016;11:77-89. 12. Calil AM, Pimenta CAM. Intensidade da dor e adequação de analgesia. Rev Latino- CONCLUSION -Am Enfermagem. 2005;13(5):692-9. 13. Conselho Federal de Enfermagem. Resolução no 429, de 8 de junho 2012. Dispõe sobre o registro das ações profissionais no prontuário do paciente, e em outros docu- The pain registries from the hospital record did not reflect the mentos próprios da enfermagem, independente do meio de suporte – tradicional ou pain reports observed in the previous study. Underreporting of eletrônico. Diário Oficila da União, n° 110, jun 2012; 288p. 14. Nascimento LA, Cardoso MG, Oliveira SA, Quina E, Sardinha DS. Manuseio da pain was verified, even though the “Acute Pain” ND was iden- dor: avaliação das práticas utilizadas por profissionais assistenciais de hospital público tified in most cases. The NI listed by the nurses favored the secundário. Rev Dor. 2016;17(2):76-80. 15. Cruz DALM, Guedes ES, Santos MA, Sousa RMC, Turrini RNT, Maia MM, et al. evaluation and pharmacological treatment of pain. These fin- Documentação do processo de enfermagem: justificativa e métodos de estudo analíti- dings suggest the need for continuous training of the Nursing co. Rev Bras Enferm. 2016;69(1):197-204. 16. Peres HHC, Cruz DALM, Lima AFC, Gaidzinski RR, Ortiz DCF, Trindade MM, et al. De- Team with emphasis on non-pharmacological pain assessment senvolvimento de Sistema Eletrônico de Documentação Clínica de Enfermagem estruturado and management. em diagnósticos, resultados e intervenções. Rev Esc Enfermagem USP. 2009;43(2):1149-55.

248 BrJP. São Paulo, 2020 jul-sep;3(3):249-52 ORIGINAL ARTICLE

Relationship of anteversion of the femoral neck with patellofemoral pain syndrome in young women not practicing regular physical activity Relação entre a anteversão de colo do fêmur e a síndrome da dor patelofemoral em mulheres jovens não praticantes de atividade física regular

Alexandre Otilio Pinto-Junior1, Yuri Rafael dos Santos Franco2, Quiteria Maria Wanderley Rocha3

DOI 10.5935/2595-0118.20200179

ABSTRACT Keywords: Bone anteversion, Bone malalignment, Femur neck, Pain, Patellofemoral pain syndrome. BACKGROUND AND OBJECTIVES: Patellofemoral pain syndrome is an anterior knee pain (or retropatellar), associated RESUMO to knee joint stress. The risk factors include musculoskeletal disorders that affect the distribution of forces acting on the knee JUSTIFICATIVA E OBJETIVOS: A síndrome da dor patelofe- joint, as in the femoral anteversion. The objective of this study moral se manifesta com dor anterior no joelho ou retropatelar, was to verify the relationship between the femoral anteversion relacionada ao aumento do “stress” articular. Os fatores de risco angle and the patellofemoral pain syndrome in young women incluem disfunções musculoesqueléticas que afetem a distribui- who do not practice regular physical activity. ção de forças na articulação do joelho, como ocorre na anteversão METHODS: This is a cross-sectional, case-control study. The femoral. O objetivo deste estudo foi verificar a relação do ângulo sample includes 100 women (G1, n=50 - anterior knee pain; de anteversão femoral com a dor anterior no joelho de mulheres G2, n=50 – control group). The instruments applied were the jovens não praticantes de atividade física regular. Anterior Knee Pain Score, numerical pain scale, and Craig’s test. MÉTODOS: Estudo transversal, caso-controle. A amostra com- The groups were compared using the Student’s t-test, p<0.05 for posta por 100 mulheres divididas nos grupos dor anterior no significant results (GraphPad Prism 8). joelho (G1) e controle (G2) cada um com 50 indivíduos. Os ins- RESULTS: The mean age was 21.5±3.45 and 20.9±2.85 years old trumentos aplicados foram: o Anterior Knee Pain Score, a escala for G1 and G2, respectively. Mean pain intensity was 4.6±1.97 numérica da dor, e teste de Craig. Os grupos foram comparados for G1, with no pain recorded in G2 (p=0.0001). The mean an- entre si pelo teste t de Student, adotando-se p<0,05 para resulta- teversion angle of the femoral neck was 16.2±4.85 degrees in dos significativos (GraphPad Prism 8). G1 and 15.6±4.87 degrees in G2 (p= 0.566). The average score RESULTADOS: A média de idade foi de 21,5±3,45 e 20,9±2,85 obtained with the Anterior Knee Pain Score was 81.4±10.46 and anos para os grupos G1 e G2, respectivamente. A intensidade 94.8±5.41 points for groups 1 and 2, respectively (p=0.0001). média da dor foi 4,6±1,97 para o G1, não havendo registro de CONCLUSION: No relationship was found between angula- dor no G2 (p=0,0001). A angulação média de anteversão do colo tion of the femoral neck and the presence of anterior knee pain, femoral foi de 16,2±4,85 graus no G1 e 15,6±4,87 graus no G2 however, a greater functional loss in the group with pain was (p=0,566). Por fim, o escore médio obtido com o Anterior Knee observed. Pain Score foi de 81,4±10,46 e 94,8±5,41 pontos para os grupos 1 e 2, respectivamente (p=0,0001). CONCLUSÃO: Não foi encontrada relação entre angulação do

Alexandre Otilio Pinto-Junior – https://orcid.org/0000-0002-7074-3390; colo femoral com a presença de dor anterior do joelho, no entanto, Yuri Rafael dos Santos Franco – https://orcid.org/0000-0003-4510-7680; observou-se que no grupo com dor havia maior perda funcional. Quiteria Maria Wanderley Rocha – https://orcid.org/0000-0001-7284-3443. Descritores: Anteversão óssea, Colo do fêmur, Dor, Mau alinha-

1. Universidade Estadual de Ciências da Saúde de Alagoas, Faculdade de Medicina, Maceió, mento ósseo, Síndrome da dor patelofemoral. AL, Brasil. 2. Universidade Guarulhos, Curso de Fisioterapia, Guarulhos, SP, Brasil. 3. Universidade Estadual de Ciências da Saúde de Alagoas, Departamento de Morfologia, INTRODUCTION Maceió, AL, Brasil.

Submitted on March 28, 2020. Patellofemoral pain syndrome (PFPS) is defined by the presence Accepted for publication on May 11, 2020. of anterior knee (retropatellar) pain, related to the increase of Conflict of interests: none – Sponsoring sources: Fundação de Amparo à Pesquisa do Estado contact pressure (stress) in the patellofemoral joint, being the de Alagoas (FAPEAL). most common athlete’s knee problem, especially in runners. Correspondence to: PFPS etiology is not well established, nevertheless, it’s related Alexandre Otilio Pinto-Júnior Rua Santa Sofia, 28 – Ponta da Terra to multifactorial causes like direct trauma or any activity that 57030-634 Maceió, AL, Brasil may cause patellofemoral joint compression, like long periods E-mail: [email protected] of sitting, squatting, going up and down stairs, which makes it © Sociedade Brasileira para o Estudo da Dor harder to diagnose1-3. 249 BrJP. São Paulo, 2020 jul-sep;3(3):249-52 Pinto-Junior AO, Franco YR and Rocha QM

Anterior knee pain impacts physical and psychic-emotional gender, aged between 18 and 30 years old, normal body mass in- aspects, influencing directly in mental health and social rela- dex (BMI) (18.5 to 24.9 kg/m2), not practicing regular physical tionships, taking to demotivation for everyday life activities1. activity. Those with a history of ligament lesion, meniscus, femo- Prevalence of PFPS in the world varies between 15-45%, its rotibial arthrosis and other previous knee diseases were excluded. more common in women by the proportion of 2:1, and in you- Sedentarism was adopted as a criteria to classify individuals as ng adults. PFPS also makes up 3% of all diseases that attack not practitioners of regular physical activities, which, in accor- the knee1,4. dance to the American College of Sports Medicine (ACSM), is PFPS risk factors include quadriceps muscle weakness and bio- determined by less than 150 minutes per week of light physical mechanical misalignments in the Q angle, tibiofemoral angle, activities7. external static rotation of the knee, tibial lateral torsion and Each participant was evaluated in a maximum time of 30 minu- hyperpronation of the foot, which affect the distribution of for- tes. Initially, the Anterior Knee Pain Scale (AKPS) was applied, ces acting on the knee joint, since their adequate alignment is a psychometric evaluation composed of 13 closed questions rela- necessary for a harmonious functioning between the hip and ted to day to day activities. The score could range between zero knee joints1-3,5. and 100 points, the smallest scores corresponding to greater knee The proximal portion of the femur is influenced by both the functional disability8. frontal and axial plane. In the frontal plane, the angle of incli- Next, the intensity of pain was measured by the Numerical Pain nation can be observed, reporting the coxa valga or vara. Whi- Scale (NPS), in which zero means ‘’absence of pain’’ and 10 ‘’the le in the axial plane the anteversion angle of the femoral neck worst pain ever felt by the interviewed’’. 1 to 3 points were con- is observed, formed through an overlapping angulation of the sidered as mild, 4 to 6 as moderate, and 7 to 10 as severe pain9. femoral condyles and center of the femoral head, with normal The measurement of the anteversion angle of the femoral value between 8° and 15°. neck was performed by the same two evaluators in all parti- The anteversion occurs when the icondylar plane passes poste- cipants through Craig’s clinical test. The individuals were po- riorly to the center of the femoral head, forming an angle greater sitioned in ventral decubitus with a 90º knee flexion. One of than 15°; if the opposite occurs, when it passes anteriorly to the the evaluators using a goniometer established the zero grade center of the femoral head, the angle formed will be less than 8°, angle; the other evaluator palpating the large trochanter per- establishing a retroversion of the femoral neck5. formed the internal rotation of the hip until its most lateral Femoral anteversion can lead to increased medial rotation of the point was reached. limb, resulting in inward deviated feet. On the other hand, if The goniometer evaluator measures the degrees of rotation in the anteversion is compensated by increased lateral tibial rota- relation to the initial point, the normal value being between 8º tion, there will be compensation with adjustment of the foot, and 15º and, above that, the anteversion of the femoral neck5,6. misaligning the knee, which will adopt the valgus pattern. The Both examiners presented similar results of the daily measure- determination of the value for this anteversion is fundamental ment established in tests before the actual collection. There was in the diagnosis and therapeutic planning with emphasis on the no therapeutic intervention for the presence of knee pain or for preventive screening of lesions. femoral neck anteversion. A clinical measurement is through Craig’s test, also called tro- This study was approved by the institution’s Research Ethics chanteric prominence test, which has a level of accuracy close Committee (CAAE 46333615.9.0000.5011). All participants to the tomographic evaluation of the angulation and has the ad- signed the Free and Informed Consent Term (FICT). vantages of low cost and easy performance. Its clinical practice is justified because it generates values equivalent to the three-di- Statistical analysis mensional tests5,6. The statistical analysis was descriptive, through mean±standard Recent studies validated the femoral anteversion angulation deviation. The groups were compared using the Student’s t test, using Craig’s test in comparison to measures obtained in compu- adopting p<0.05 for significant differences. Calculations were ted tomography (CT) in children, however, there are not many performed using the GraphPad Prism 8® statistical software. records of the test in a young adult population5. This study’s objective was to verify the existence of the relation between the an- RESULTS gulation of the hip internal rotation and the intensity of anterior or retropatellar pain in the knee of young women not practicing The mean age found was 21.5±2.4 and 20.9±2.6 years old, res- regular physical activities. pectively, for G1 and G2. The mean pain intensity measured by NPS was 4.58±1.97 and 0±0.0 for groups 1 and 2, respectively, METHODS presenting significant difference (p=0.0001). The mean angulation found for anteversion of the femoral neck Cross-sectional, observational, case-control study conducted at was 16.2 ± 4.85 degrees at G1 and 15.6 ± 4.87 degrees at G2, a public state university in Alagoas. The sample was composed p=0.566. Finally, the mean value obtained with AKPS was of 100 women university students, organized in two groups: 81.4±10.46 and 94.8±5.41 points for G1 and G2, respectively, G1 (n=50) - with anterior knee pain; and G2 (n=50) - control with p=0.0001 (Figure 1). The characterization of the sample is group, with no report of knee pain. Inclusion criteria was: female grouped in table 1. 250 Relationship of anteversion of the femoral neck with patellofemoral pain BrJP. São Paulo, 2020 jul-sep;3(3):249-52 syndrome in young women not practicing regular physical activity

Table 1. Sample characterization. Values expressed in simple mean±SD Variables Groups G1 (n=50) G2 (n=50) Total (n=100) p-value Age 21.5±3.45 20.9 (±2.58) 21.2 (±3.05) - Level of pain (NPS) 4.6±1.97 0 2.3 (±2.69) 0.0001* Femoral neck anteversion angle (degrees) 16.2±4.85 15.6 (±4.87) 15.9 (±4.84) 0.566 Function (AKPS) 81.4±10.46 95.2 (±5.41) 88.3 (±10.82) 0.0001* NPS = numerical pain scale; AKPS = Anterior Knee Pain Score; G1 = anterior knee pain; G2 – control group; n – number of participants. *statistically significant difference.

significance. Authors6 investigated the Craig’s test accuracy 100 and concluded that it was closer to the results obtained by CT when compared to radiologic evaluation, suggesting that 80 the test could be used in an outpatient population screening when tomography is not available. Such findings influenced 60 this study to perform only the clinical assessment of the femoral angulation, since there was no resources for a tomography 5 40 analysis. The study also showed that women with increased femoral anteversion tend to present higher static external ro- 20 tation of the knee, which can be a risk factor for PFPS; while men did not show this association in the findings. Moreover,

Anterior Knee Pain Score (AKPS) Anterior Knee Pain Score another cohort study10 observed that, the higher the angle 0 G1 (n=50) G2 (n=50) of internal rotation of the hip during a dynamic activity, the higher the risk for developing PFPS. Figure 1. Knee function comparison Moreover, the same study also reported that the increase in AKPS = Anterior Knee Pain Score; G1 = anterior knee pain; G2 = control group; internal rotation of the hip in relation to the tibia and the n = number of participants. knee valgus were directly related to increased “stress” in the femoropatellar joint. Therefore, in contrast to the present study, no relation between the anteversion of the femoral neck DISCUSSION and the appearance of anterior knee pain in sedentary young women was found (p=0.566). The number of studies that assess the relation between knee The sample was limited to age and the female gender. The age pain and hip musculature has increased. This study presents factor is fundamentally important because in young people, as in a pioneer way the relation of pain and the transversal an- this study’s participants, muscle strength is greater with less loss gulation of the femoral neck. The outcomes of pain, function of fibers, unlike individuals of more advanced age, in which the and anteversion angulation of the femoral neck were evalua- number of fibers decreases due to the physiological process of ted and no difference was identified between the angulations aging12. Study13 verified that women who had more knee inju- of people with anterior knee pain and those who do not have ries, when compared to men, had a tendency to have a larger these angulations (p=0.566). femoral anteversion angulation. The pain and function outco- Muscular power depends on two primordial factors, the len- mes, considered secondary, obtained differences (p=0.0001 for gth-tension and cross-sectional area of the muscle. The initial both). The presence of pain is justified in G1, with a mean hypothesis was that, with more femur anteversion, the leng- value of 4.6 points in the NPS, while absent in G2. th-tension of the lateral hip rotator muscles would be bigger, In that sense, a notorious clinical difference was expected for leading to a mechanical disadvantage for that muscle, favo- cases of anterior knee pain. As for function, the value was ob- ring the dynamic valgo, an injury factor for the patellofemoral served in the pain group characterized by a score of patellofe- joint. That would be sustained through the mean angulation moral joint disorder. The relation between pain and lessened of women in pain (G1), which is very close to the borderli- function can be ascertained due to the lower knee function ne value of 15 degrees given as normal. In addition to that, score of the pain group (G1), denoting more functional limi- biomechanical studies show that an accentuated femoral an- tation of this joint14. teversion is associated with bigger movements of the dynamic One of the strengths of the present study was the covered valgo, which results in a bigger risk for PFPS5,6,10,11. A study5 evaluators, which had clinical experience in order to effective used CT measurements to validate Craig’s test and found that apply the test. The limiting factor was the sample being cho- the femoral neck angulation evaluated by this test may par- sen by convenience, with no sample calculation Confirmar tially be the true anteversion angulation, as other factors may trad, making it impossible to project the results to the global influence its value, even though the test has important clinical population. 251 BrJP. São Paulo, 2020 jul-sep;3(3):249-52 Pinto-Junior AO, Franco YR and Rocha QM

CONCLUSION 2020;26(1):e10190103. 3. Arrebola LS, Carvalho RT, Lima VCO, Percivale KAN, Oliveira VGC, Pinfildi CE. Influence of body mass index on patellofemoral pain. Fisioter Mov. 2020;33:e003309. No influence of the femoral neck angulation on the emergence 4. Franco BAFM, Sadigursky D, Daltro GC. Caracterização por estudo anatomorradio- gráfico da posição patelar em pacientes portadores de síndrome femoropatelar. Rev of anterior knee pain in young women not practicing regular Bras Ortop. 2018;53(4):410-14. physical activities was found, however, it was possible to observe 5. Uota S, Morikita I, Shimokochi Y. Validity and clinical significance of a clinical method to measure femoral anteversion. J Sports Med Phys Fitness. 2019;59(11):1908-14. that femoropatellar joint function was undermined, as well as a 6. Patro BP, Behera S, Das SS, Das G, Patra SK, Prabhat V. Estimation of femoral neck greater level of pain in proportion to the anteversion angulation. anteversion in adults: a comparison between clinical method, radiography, and computed tomography at a tertiary-care center in Eastern India. Cureus. 2019;11(4):e4469. 7. Romancini JLH, Guariglia D, Nardo Jr N, Herold P, Pimentel GGA, Pupulin ART. ACKNOWLEDGMENTS Níveis de atividade física e alterações metabólicas em pessoas vivendo com HIV/ AIDS. Rev Bras Med Esporte. 2012;18(6):356-60. 8. Fukuda TY, Melo WP, Zaffalon BM, Rossetto FM, Magalhães E, Bryk FF, et al. Hip Thanks to the Fundação de Amparo à Pesquisa do Estado de Alagoas posterolateral musculature strengthening in sedentary women with patellofemoral (FAPEAL – Alagoas State Research Support Foundation), for fi- pain syndrome: a randomized controlled clinical trial with 1-year follow-up. J Orthop Sports Phys Ther. 2012;42(10):823-30. nancing this study; and the Universidade Estadual de Ciências da 9. dos-Santos GK, Silva NC, Alfieri FM. Effects of cold versus hot compress on pain in Saúde de Alagoas (UNCISAL – Alagoas Health Sciences State Uni- university students with primary dysmenorrhea. BrJP. 2020;3(1):25-8. 10. Uota S, Nguyen AD, Aminaka N, Shimokochi Y. Relationship of knee motions with versity) for the location where the research was carried out. static leg alignments and hip motions in frontal and transverse planes during double- -leg landing in healthy athletes. J Sport Rehabil. 2017;26(5):396-405. REFERENCES 11. Kujawa M, Goerlitz A, Rutherford D, Kernozek TW. Patellofemoral joint stress during running with added load in females. Int J Sports Med. 2020;41(6):412-8. 12. Barbosa-Silva TG, Bielemann RM, Gonzalez MC, Menezes AM. Prevalence of sar- 1. Kunene SH, Ramklass S, Taukobong NP. The impact of anterior knee pain on the copenia among community-dwelling elderly of a medium-sized south American city: quality of life among runners in under-resourced communities in Ekurhuleni, Gau- results of the COMO VAI? study. J Cachexia Sarcopenia Muscle. 2016;7(2):136-43. teng, South Africa. S Afr J Sports Med. 2018;30(1):1-6. 13. Nguyen AD, Shultz SJ, Schmitz RJ. Landing biomechanics in participants with diffe- 2. Lima KMM, Flôr JS, Barbosa RI, Marcolino AM, Almeida MG, Silva DC, et al. Ef- rent static lower extremity alignment profiles. J Athl Train. 2015;50(5):498-507. fects of a 12-week hip abduction exercise program on the electromyographic activity 14. Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O, et al. of hip and knee muscles of women with patellofemoral pain: a pilot study. Motriz. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63.

252 BrJP. São Paulo, 2020 jul-sep;3(3):253-7 ORIGINAL ARTICLE

Cross-cultural adaptation and content validity evidence of the Brazilian version of the Nociception Coma Scale-revised Adaptação transcultural e evidência de validade de conteúdo da versão brasileira da Nociception Coma Scale-revised

Mariana Bucci Sanches1,2, Cristiane Vias França Silva2, Yasmin Mohamed Ali1, Marcio Matsumoto3, João Valverde Filho3, Marina de Góes Salvetti1

DOI 10.5935/2595-0118.20200180

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: There are communica- JUSTIFICATIVA E OBJETIVOS: Em pacientes com desor- tion barriers to assess pain in patients with consciousness and dens de consciência e distúrbios cognitivos há barreiras de co- cognitive disorders. This study aimed to make the cross-cultural municação para a avaliação da dor. O objetivo deste estudo foi adaptation of the Nociception Coma Scale-Revised (NCS-R) to realizar a adaptação transcultural da Nociception Coma Scale-revi- the Portuguese language and check the validation evidence of the sed (NCS-R) para a língua portuguesa e verificar as evidências de content of the NCR-R Brazilian version in non-communicative validade de conteúdo da versão brasileira da NCS-R em pacien- patients with consciousness and cognitive disorders. tes não comunicativos com desordens de consciência e distúrbios METHODS: This is a methodological study to check the cros- cognitivos. s-cultural adaptation of the NCR-R, divided into two stages: MÉTODOS: Estudo metodológico para adaptação transcultural cross-cultural adaptation and check of the content validity. The da NCS-R dividido em duas etapas: adaptação transcultural e cross-cultural adaptation phase included an initial translation, verificação da validade de conteúdo. A fase de adaptação trans- synthesis of translations, back-translation, expert committee, cultural incluiu a tradução inicial, síntese das traduções, retrotra- and cognitive debriefing based on Beaton and Price. A second dução, comitê de especialista e debriefing cognitivo baseado em expert committee evaluated the translated and adapted version Beaton e Price. A versão traduzida e adaptada foi avaliada por to check the content validity index um segundo comitê de especialistas para a avaliação do índice de RESULTS: The NCS-R scale was translated and cross-culturally validade de conteúdo. adapted, presenting good evidence of content validity with a RESULTADOS: A escala NCS-R foi traduzida, adaptada do Content Validity Index of 0.86. ponto de vista transcultural e apresentou boa evidência de vali- CONCLUSION: The NCS-R is translated and transculturally dade de conteúdo com Índice de Validade de Conteúdo de 0,86. adapted and has good evidence of content validity. CONCLUSÃO: A NCS-R encontra-se traduzida e adaptada do Keywords: Consciousness disorders, Pain, Psychometrics, Nur- ponto de vista transcultural, e possui boa evidência de validade sing assessment, Validation studies. de conteúdo. Descritores: Avaliação em enfermagem, Dor, Estudos de valida- ção, Psicometria, Transtornos da consciência.

INTRODUCTION Mariana Bucci Sanches – https://orcid.org/0000-0003-3474-7375; Cristiane Vias França Silva – https://orcid.org/0000-0002-8312-8514; Yasmin Mohamed Ali – https://orcid.org/0000-0001-9254-8062; Pain is defined as sensorial and emotional experience, normally Marcio Matsumoto – https://orcid.org/0000-0003-4425-4902; caused by a real or potential tissue lesion, and each individual João Valverde Filho – https://orcid.org/0000-0002-5214-2831; Marina de Góes Salvetti – https://orcid.org/0000-0002-4274-8709. learns to use this term based on their previous experiences. Besides generating significant physical and emotional stress to 1. Universidade de São Paulo, Escola de Enfermagem, São Paulo, SP, Brasil. 2. Hospital Sírio-Libanês, Enfermagem Especializada, Serviço de Tratamento da Dor, São patients and their caregivers, pain has a negative economic and Paulo, SP, Brasil. social impact1. 3. Hospital Sírio-Libanês, Departamento de Anestesiologia, Serviço de Tratamento da Dor, São Paulo, SP, Brasil. In this sense, self-report is considered the gold standard to assess pain. However, with non-communicative patients, for example, Submitted on April 24, 2020. sedated patients, patients in mechanical ventilation, and with Accepted for publication on May 29, 2020. Conflict of interests: none – Sponsoring sources: none. severe neurological lesions, it is necessary to have observational instruments to identify the symptom2. Correspondence to: Rua Afonso de Freitas, 320 – Paraíso In patients with severe neurological lesions and consciousness 04006-051 São Paulo, SP, Brasil. disorders, the most used term is nociception assessment, which E-mail: [email protected] [email protected] is defined as the neural coding process and the processing of the © Sociedade Brasileira para o Estudo da Dor noxious stimulus3,4, that is mediated by lateral and medial brain 253 BrJP. São Paulo, 2020 jul-sep;3(3):253-7 Sanches MB, Silva CV, Ali YM, Matsumoto M, Valverde Filho J and Salvetti MG connections with differentiation between the areas involved in the Given the relevance to research and clinical practice, studies perception of pain versus the suffering related to the consciousness about the use of the NCS-R are necessary. In this sense, it is of the perception of the pain in question5,6. It is related to the believed that translation, transcultural adaptation, and check of sensitive-discriminative dimension that activates the lateral pain the evidence on content validity of the NCS-R in the national system, including lateral portions of the thalamus, primary (S1) context would provide the necessary input to make the clinical and secondary (S2) somatosensory cortex, and insula7,8. decision for the population at hand. Concerning the medial pain system, the descending connec- The objective of this study was to perform the transcultural tions of the anterior cingulate cortex, the medial region of the adaptation and check the evidence on content validity of the thalamic nuclei and periaqueductal gray, act on the modulation Brazilian version of the NCS-R. of the response to the noxious stimulus. The cingulate gyrus, the cerebellar tonsil, hippocampus, hypothalamus, locus coeru- METHODS leus, orbitofrontal cortex, and prefrontal cortex have a role in the pain-related affective behavior7. The interconnectivity bet- Its is a methodological study to adaptation of the NCS-R. Caro- ween the periaqueductal gray and the orbitofrontal cortex is line Schnakers, the author, authorized the transcultural adapta- associated with the cognitive and emotional responses in the tion process via electronic mail. The study was conducted from presence of pain7. February to August 2019. Therefore, the integration of several areas of the brain due to The transcultural adaptation was based on studies11,12, and it had a noxious stimulus characterizes pain, according to Melzack, as the following phases: translation, translation synthesis, back- a cognitive-evaluative, affective-motivational, and sensory-dis- -translation, experts’ committee, submission of the adapted ver- criminative response9. Although most of today’s evidence point sion to the author, and cognitive debriefing. to the fundamental role of the thalamus-cortex interaction that As in previous studies for the transcultural adaptation of the characterizes pain as a conscious experience, there are some ques- NCS-R, it was decided not to perform the pre-test but the cog- tions in relation to patients with consciousness disorders7,9. nitive debriefing11-13 instead. A study using positron emission tomography-computed tomo- The translation was performed by two translators invited to par- graphy (PET-CT) investigated the responses to the processing ticipate by electronic mail, and upon acceptance, the instrument of pain in patients with Unresponsive Wakefulness Syndrome was sent by email. (UWS) and healthy individuals, showing an increase in blood Translator (T1) is Brazilian, a health professional with proficien- flow in the regions of the midbrain, contralateral thalamus, and cy in English and experience in the subject of the study, which that probably, patients in vegetative state do not feel the painful provided the translation version T1 with greater scientific simi- stimuli in an integrative and conscious manner7,8. larity with the instrument. Translator (T2) is an English teacher, On the other hand, smaller and more recent studies showed diffe- with no background in the health area, and produced the trans- rent results with the activation of S1, S2, anterior cingulate cortex lation version T2. and insula, areas related with the affective dimension of pain, in- The translation synthesis was performed by a Brazilian translator, dicating that despite the alteration, it is possible to have the per- English teacher with no background in the health area, and later ception of pain in some patients in a vegetative state, even when sent to translators T1 and T2. At the end of this step, we obtai- compared to patients with a minimum state of conciousness7. ned the synthesis version T1-T2. Another interesting point is that due to the complexity and cli- Two American translators, English teachers, proficient in Bra- nical variations, a considerable number of patients diagnosed as zilian Portuguese, performed the back-translation and versions in a vegetative state were, in fact, in a state of minimal cons- BT1 and BT2. ciousness, emphasizing the importance of using the correct ins- An experts’ committee was created to evaluate the semantic, truments to assess and treat pain in patients with consciousness idiomatic, conceptual, and experimental equivalences, following disorders properly9. the criteria of knowledge about the transcultural adaptation pro- The first instrument to assess nociception in patients with cons- cess, master English and Portuguese languages, and knowledge ciousness disorders was the Nociception Coma Scale (NCS), de- related to the subject in question11. veloped by study3 The NCS was developed from observations that Fifteen invites were sent to participate in the committee, via elec- suggest painful behaviors with four items: motor, verbal, visual tronic mail, and the acceptance was formalized by signing the and facial expression response, with scores where zero means the Free and Informed Consent Term (FICT) by the participants. absence of response in the face of a nociceptive stimulus and 12 The experts’ committee comprised of one psychometrician, one is the maximum response in the face of a nociceptive stimulus3. neurologist, one of the translators (T1), one anesthesiologist spe- A later study using the NCS in 64 patients showed higher sco- cialized in pain, and one nurse specialized in intensive care11. res in the face of nociceptive stimuli in terms of verbal, motor, Upon acceptance, the instruction forms to evaluate the instru- and facial expression responses, suggesting good results regarding ment were sent together with a spreadsheet containing the ori- sensitivity. However, the item visual response did not present ginal, the translated versions (T1 and T2), the synthesis (T12), any difference. In light of these results, the authors proposed the and the two back-translations (BT1 and BT2). Nociception Coma Scale-Revised (NCS-R) with scores from The version produced in this phase was analyzed by the resear- zero to nine, but there is still no consensus on the cut-off point10. chers following the agreement criteria among the experts with

254 Cross-cultural adaptation and content validity evidence of the BrJP. São Paulo, 2020 jul-sep;3(3):253-7 Brazilian version of the Nociception Coma Scale-revised their suggestions for the items considered questionable or ina- ter the approval of this project by the Research Ethics Commit- dequate. The version resulting from the experts’ committee was tee (CAAE: 05557018.9.0000.5461) submitted to the author of the scale via electronic mail. After the submission, a second experts’ committee was created RESULTS to evaluate the content validity. Twenty-five invites were sent by electronic mail directed to professionals following the criteria on The scale has only three items that are similar to the behavio- knowledge about the subject and knowledge about the transcul- ral questions described in other parameters of the neurologic tural adaptation process and evaluation of the evidence of con- assessment. tent validity. Table 1 shows the versions of the first three steps of the adapta- The acceptance to participate in the committee was also formation process of the NCS-R: Br version. lized by signing the FICT. The committee comprised of three A third translator analyzed the two translations, and it was ob- Ph.D., one physician, two nurses, two masters in nursing, and served that the version of the translator T1 was, in general, more two specialized nurses. After the acceptance, the researcher sent, adequate. Among the adjustments, it was suggested for the “Mo- via electronic mail, a form with instructions to complete the tor response” item, subitem Withdrawal in flexion, in item “Ver- evaluations and a spreadsheet with the original and pre-final verbal response” subitem Oral reflex/fright response. These items sions of the NCS-R in Brazilian Portuguese. were also considered questionable by the experts’ committee. Four health professionals were invited for the cognitive debrie- Translations were submitted to the author’s analysis, Dr. Sch- fing: three nurses and one nursing technician who had a 1-hour nakers, who disagreed with the back-translation of the subitem training to apply the pre-final version in 24 patients with cons- “Oral reflex/fright response,” and provided the Application Ma- ciousness disorders12,14,15. nual of the NCS-R suggesting to refer to it for term adequacy. The descriptive statistics were used to analyze the data to characte- Upon these suggestions, the researcher and the adviser reviewed rize the subjects. Values above 0.78 of the Content Validity Index the translation synthesis and the back-translations, and the subi- (CVI) were considered acceptable for agreement in the items cla- tem was changed to “Oral reflex/involuntary oral movements.” rity, essentiality, and relevancy among the experts, and the respon- It was again submitted to the author and approved, and then se options were not clear, somewhat clear, clear, very clear16. evaluated by a new experts’ committee; The results presented The authorization to conduct the study was requested to the below relate to the equivalence evaluation and content validity Institute of Teaching and Research of the Hospital Sírio-Liba- (Tables 2 and 3). nês, and subsequently, the project was submitted to the Research When the experts checked the agreement index concerning the Ethics Committee of the Institution. Data collection started af- equivalences, it was observed that the instrument had CVI values

Table 1. Description of the versions produced by the translation, synthesis, and back-translation of the NCS-R. São Paulo, 2019. Translation T1 Translation T2 Suggestion - Synthesis T-12 Back-translation BT1 Back-translation BT2 Escala de nocicepção no Escala de nocicepção no Escala de nocicepção no coma Nociception Coma Nociception Coma Title coma - revisada coma - revisada - revisada Scale - Revised Scale - Revised Resposta motora Resposta motora Resposta motora Motor response Motor response 3. Localiza estímulo do- 3. Localização para estí- 3. Localização do estímulo do- 3. Localization for 3. Localization for loroso mulo doloroso loroso painful stimulus painful stimulus 2: Retirada do estímulo 2: Retirada de flexão 2: Retirada em flexão 2: Move by flexion 2: Withdrawal of fle-

Items doloroso xion 1* Postura anormal 1* Pose anormal 1* Postura anormal 1* Abnormal posture 1* Abnormal posture 0 Nenhuma/relaxada 0 Nenhuma/flácida 0 Nenhuma/flácida 0 None/flaccid 0 None/flaccid Resposta verbal Resposta verbal Resposta verbal Verbal response Verbal response 3. Verbalização (com- 3. Verbalização (inteligível) 3. Verbalização (inteligível) 3. Verbalization (intelli- 3. Verbalization (intelli- preende) gible) gible) 2: Emite sons (não espe- 2: Vocalização 2: Emite sons 2: Emits sounds 2: Emits sounds

Items cífico) 1* Gemido 1* Gemidos 1* Gemidos 1* Groans 1* Moans 0 Nenhuma 0 Nenhuma 0 Nenhuma 0 None 0 None Expressão facial Expressão facial Expressão facial Facial expression Facial expression 3. Choro 3. Choro 3. Choro 3. Crying 3. Cry 2: Careta/franzir de testa 2: Careta 2: Careta 2: Grimace 2: Grimace

Items 1* Espanto/susto 1* Reflexivo oral/resposta 1* Reflexivo oral/resposta de 1* Oral reflex/fright1* Oral reflex/fright res- de susto susto response ponse 0 Nenhuma 0 Nenhuma 0 Nenhuma 0 None 0 None

255 BrJP. São Paulo, 2020 jul-sep;3(3):253-7 Sanches MB, Silva CV, Ali YM, Matsumoto M, Valverde Filho J and Salvetti MG

Table 2. Result of the equivalence evaluation by the experts’ commit- close to 1, that is, it presented satisfactory results in agreement tee. São Paulo, 2019 with the criteria and values accepted as reference. The cognitive Total of agreement* debriefing was performed by three nurses and one nurse technician who had a 1-hour training to apply the pre-final version in 24 patients. No need for adjustments in the produced version

Items was identified (Table 4). Idiomatic Semantics Conceptual Experimental Table 4. Pre-final version of the Nociception Coma Scale-Revised 1 Nociception coma scale - revi- 1.00 1.00 1.00 1.00 (Br), São Paulo, 2019 sed (Br) Motor response 2 Motor response 1.00 1.00 1.00 1.00 Localization of the painful stimulus (=3) 3 Localization of the painful stimu- 1.00 1.00 1.00 1.00 lus (=3) Withdrawal in flexion (=2) 4 Withdrawal in flexion (=2) 1.00 1.00 1.00 1.00 Abnormal posture (=1) 5 Abnormal posture (=1) 1.00 1.00 1.00 1.00 None/flaccid (=0) 6 None/flaccid (=0) 1.00 1.00 1.00 1.00 Verbal response 7 Verbal response 1.00 1.00 1.00 1.00 Verbalization (intelligible) (=3) 8 Verbalization (intelligible) (=3) 1.00 1.00 1.00 1.00 Vocalization (=2) 9 Vocalization (=2) 1.00 1.00 1.00 1.00 Groans (=1) 10 Groans (=1) 1.00 1.00 1.00 1.00 None (0) 11 None (0) 1.00 1.00 1.00 1.00 Facial expression 12 Facial expression 1.00 1.00 1.00 1.00 Crying (=3) 13 Crying (=3) 1.00 1.00 1.00 1.00 Grimace (=2) 14 Grimace (=2) 1.00 1.00 1.00 1.00 15 Oral reflex/involuntary oral mo- Oral reflex/involuntary oral movements (=1) 0.86 0.86 0.86 0.86 vements (=1) None (0) 16 None (0) 1.00 1.00 1.00 1.00 * CVI = Content Validity Index. DISCUSSION

Table 3. Results of the content validity index by the experts’ commit- Pain is a subjective experience, and the patient’s self-report is tee. São Paulo, 2019 considered the gold standard to assess pain. However, in an Total of environment of patient care, pain assessment is a challenge agreement* since many times they are unable to communicate3,15. Over the last decades, we have seen many efforts to develop specific and accurate instruments to facilitate pain identification Items Clarity in non-communicative patients, since pain management can Relevancy Essentiality improve the outcomes for these patients 3. In acute or chronic 1 Nociception coma scale - revised (Br) 1.00 1.00 1.00 stages of patients with severe brain lesions, there are situations 2 Motor response 1.00 1.00 1.00 that can lead to pain, mainly during care and mobilization6,7. 3 Localization of the painful stimulus 1.00 1.00 1.00 In a study using neuroimaging, the authors suggested that there 4 Withdrawal in flexion 1.00 1.00 1.00 is the preservation of the capacity to perceive pain in patients 5 Abnormal posture 1.00 1.00 1.00 in minimum consciousness estate, and in some patients in a ve- 5 6 None/flaccid 1.00 1.00 1.00 getative state, reinforcing the need to assess and manage pain . 7 Verbal response 1.00 1.00 1.00 This study followed all the steps of the NCS-R transcultural process recommended by Beaton11, except for the pre-test; 8 Verbalization (intelligible) 1.00 1.00 1.00 however, the cognitive debriefing, according to Price12, was 9 Vocalization 1.00 1.00 1.00 used instead. In another NCS-R transcultural adaptation stu- 10 Groans (=1) 1.00 1.00 1.00 dy, the pre-test was not performed for being considered that 11 None (0) 1.00 1.00 1.00 the terms used in the item were widespread in the clinical 12 Facial expression 1.00 1.00 1.00 practice for this population17. The content validity assessment 13 Crying (=3) 1.00 1.00 1.00 of the NCS-R indicated satisfactory values for all items and 14 Grimace (=2) 1.00 1.00 1.00 response options16. 15 Oral reflex/involuntary oral movements 0.86 0.86 0.86 It is worth mentioning that the score of the oral reflex/in- (=1) voluntary movements option was above the desired, but the 16 None (0) 1.00 1.00 1.00 lowest index in agreement, indicating some fragility in the * CVI = Content Validity Index. response option. 256 Cross-cultural adaptation and content validity evidence of the BrJP. São Paulo, 2020 jul-sep;3(3):253-7 Brazilian version of the Nociception Coma Scale-revised

This result can be explained by the more direct correspondence 3. Schnakers C, Chatelle C, Vanhaudenhuyse A, Majerus S, Ledoux D, Boly M, et al. The Nociception Coma Scale: a new tool to assess nociception in disorders of cons- between the item facial expression and the grimace response op- ciousness. Pain. 2010;148(2):215-9. tion compared with the oral reflex/involuntary movements that 4. Apkarian AV, Bushnell MC, Rolf-Detlef T, Jon-Kar Z. Human brain mechanisms of 17 pain perception and regulation in health and disease. Eur J Pain. 2005;9(4):463-84. can be considered a non-specific descripton . Other authors 5. IASP Taxonomy Working Group. Classification of chronic pain (Revised) [internet]. conducted studies with patients with consciousness disorders 2nd ed. Washington, DC: IASP Publications; 2011 [2018 mar 11]. Available from: and described grimace as the most characteristic aspect of facial https://s3.amazonaws.com/rdcms-iasp/files/production/public/Content/ContentFol- 15,17,18 ders/Publications2/ClassificationofChronicPain/Part_III-PainTerms.pdf pain expression . 6. Schnakers C, Zasler N. Assessment and management of pain in patients with disorders The understanding of the essence of the construct and the pur- of consciousness. PM R. 2015;7(11 Suppl):S270-7. 7. Laureys S, Faymonville ME, Peigneux P, Damas P, Lambermont B, Del Fiore G, et al. pose of an observational instrument of pain are necessary, since Cortical processing of noxious somatosensory stimuli in the persistent vegetative state. the score indicates the presence or absence of a painful behavior, Neuroimage. 2002;17(2):732-41. suggesting that this instrument should be assessed based on the 8. Wade DT. How often is the diagnosis of the permanent vegetative state incorrect? A review of the evidence. Eur J Neurol. 2018;25(4):619-25. 15,19 clinimetric point of view . 9. Schnakers C, Chatelle C, Majerus S, Gosseries O, De Val M, Laureys S. Assessment One of the highlights of this study is the availability of an instru- and detection of pain in noncommunicative severely brain-injured patients. Expert Rev Neurother. 2010;10(11):1725-31 ment that provides evidence of the content validity to assess pain 10. Chatelle C, Majerus S, Whyte J, Laureys S, Schnakers C. A sensitive scale to assess in a population where pain is under-identified and, therefore, nociceptive pain in patients with disorders of consciousness. J Neurol Neurosurg Psychiatry. 2012; 83(12):1233-7. not managed. 11. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of A limitation of the study is that the pre-test was not performed. cross-cultural adaptation of self-report measures. Spine. 2000;25(24):3186-91. 12. Price VE, Klaassen RJ, Bolton-Maggs PH, Grainger JD, Curtis C, Wakefield C, et al. Measuring disease-specific quality of life in rare populations: a practical approach to CONCLUSION cross-cultural translation. Health Qual Life Outcomes. 2009;7:92. 13. Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015;68(4):435-41. It was possible to adapt the NCS-R to the Brazilian Portuguese 14. Costello AB, Osborne JW. Best practices in exploratory factor analysis: Four re- language. The tests performed showed that the NCS-R provides commendations for getting the most from your analysis. Pract Assess Res Eval. 2005;10(7):1-9. adequate evidence of the content validity. Further studies should 15. Vink P, Lucas C, Maaskant JM, van Erp WS, Lindeboom R, Vermeulen H. Clinime- be performed to confirm these findings and expand the evalua- tric properties of the Nociception Coma Scale (-Revised): A systematic review. Eur J tion of the validity evidence of the version of the scale in our Pain. 2017;21(9):1463-74. 16. Alexandre NMC, Coluci MZO. Validade de conteúdo nos processos de construção e practice. adaptação de instrumentos de medidas. Ciênc Saúde Coletiva. 2011;16(7):3061-8. 17. Chatelle C, Laureys S, Demertzi A. Pain and nociception in disorders of conscious- REFERENCES ness. In: Garcia-Larrea L, Jackson PL, editors. Pain and the conscious brain. Philadel- phia: Wolters Kluwer Health; 2016. 139-54p. 18. Bernard C, Delmas V, Duflos C, Molinari N, Garnier O, Chalard K, et al. Assessing 1. Aydede M. Does the IASP definition of pain need updating? Pain Rep. 2019;4(5):e777. pain in critically ill brain-injured patients: a psychometric comparison of 3 pain scales 2. Kawagoe CK, Matuoka JY, Salvetti MG. Instrumentos de avaliação da dor em pa- and videopupillometry. Pain. 2019;160(11):2535-43. cientes críticos com dificuldade de comunicação verbal: revisão de escopo. Rev Dor. 19. Fava GA, Tomba E, Sonino N. Clinimetrics: the science of clinical measurements. Int 2017;18(2):161-5. J Clin Pract. 2012;66(1):11-5.

257 BrJP. São Paulo, 2020 jul-sep;3(3):258-62 REVIEW ARTICLE

Influence of the Pilates method on quality of life and pain of individuals with fibromyalgia: integrative review Influência do método Pilates na qualidade de vida e dor de indivíduos com fibromialgia: revisão integrativa

Bruna Lira Brasil Cordeiro1, Igor Henriques Fortunato1, Fabiano Ferreira Lima1, Rinaldo Silvino Santos1, Manoel da Cunha Costa1, Aline Freitas Brito1

DOI 10.5935/2595-0118.20200049

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: Fibromyalgia syndrome JUSTIFICATIVA E OBJETIVOS: A síndrome de fibromialgia is linked to a process of pain and loss of quality of life. The Pila- está ligada a um processo de dor e perda da qualidade de vida, o tes Method can be a form of physical exercise that alleviates pain. método Pilates pode ser uma forma de exercício físico que atenua Thus, the aim of this study was to investigate whether interven- as dores. Dessa forma, o objetivo deste estudo foi investigar se in- tions with the Pilates method can provide improvements in pain tervenções com o método Pilates pode propiciar melhoras na dor and quality of life for people with fibromyalgia syndrome. e qualidade de vida de pessoas com síndrome da fibromialgia. CONTENTS: A database integrative review, searching for origi- CONTEÚDO: Trata-se uma revisão integrativa nas bases de da- nal articles published until November 2019. This review reports dos, com busca por artigos originais publicados até novembro the main results for pain and quality of life for people with fi- de 2019. Buscou-se relatar os principais resultados para dor e bromyalgia syndrome who participated in Pilates interventions, qualidade de vida das pessoas com síndrome da fibromialgia que as well as the method’s prescription, the variables and the instru- participaram de intervenções com Pilates, a prescrição do méto- ments used in the interventions to better understand the phy- do, as variáveis e os instrumentos utilizados nas intervenções para sical education professional who will intervene with the Pilates melhor compreensão do profissional de educação física que ve- method in people with fibromyalgia syndrome. Following the nha a intervir com o método Pilates em pessoas com síndrome da inclusion criteria, 5 studies were selected. The results found im- fibromialgia. Seguindo os critérios de inclusão, 5 estudos foram proved quality of life and decreased pain. selecionados. Os resultados encontrados apontaram melhoras na CONCLUSION: It was found that the Pilates method may be qualidade de vida e diminuição da dor. an interesting intervention for individuals with fibromyalgia CONCLUSÃO: Observou-se que o método Pilates pode ser syndrome, because of its safety and therapeutic effects on the uma intervenção interessante para indivíduos com síndrome de adversities of fibromyalgia already within 4 weeks of training. fibromialgia pela sua segurança e efeitos terapêuticos nas adver- Still, it’s important to highlight the importance of continuing sidades da fibromialgia já com 4 semanas de treinamento. Ainda training to obtain its beneficial effects on pain and quality of life assim, é importante destacar a importância da continuidade do of individuals. treinamento para obtenção dos seus efeitos benéficos para dor e Keywords: Exercise movement techniques, Fibromyalgia, Training. qualidade de vida dos indivíduos. Descritores: Fibromialgia, Técnicas de movimento do exercício, Treinamento de Pilates.

INTRODUCTION Bruna Lira Brasil Cordeiro – https://orcid.org/0000-0003-4061-5993; Igor Henriques Fortunato – https://orcid.org/0000-0001-7124-2371; Fabiano Ferreira Lima – https://orcid.org/0000-0003-1841-5098; Fibromyalgia syndrome (FMS) is the world’s second most com- Rinaldo Silvino Santos – https://orcid.org/0000-0002-5752-5129; mon rheumatological disorder and is present in 0.7 to 5% of the  Manoel da Cunha Costa – https://orcid.org/0000-0001-8815-8846; 1 Aline Freitas Brito – https://orcid.org/0000-0002-7088-4935. general population . In Brazil, fibromyalgia (FM) is the second most common rheumatological disease, present in 2.5% of the 1. Universidade de Pernambuco, Escola Superior de Educação Física, Programa Associado de Pós-Graduação em Educação Física Recife, PE, Brasil. population, mostly females with an average age of 35 to 55 years old2. FM is a rheumatological syndrome featuring a diffuse and Submitted on January 4, 2020 chronic musculoskeletal pain scenario, which is associated to Accepted for publication on June 1, 2020 Conflict of interests: none – Sponsoring sources: none others symptoms like fatigue, sleep disorders, morning stiffness, cognitive disorders, chronic headache, irritable bowel syndrome, Correspondence to: Rua Arnóbio de Marques, 310 – Bairro Santo Amaro vague complaints of edema, as well as some psychological disor- 50110-130 Recife, PE, Brasil. ders like anxiety and depression1. E-mail: [email protected] Although not characterized by lethality, FMS generates a large im- © Sociedade Brasileira para o Estudo da Dor pact in the functional capacity of all aspects of life, like work, lei- 258 Influence of the Pilates method on quality of life and pain BrJP. São Paulo, 2020 jul-sep;3(3):258-62 of individuals with fibromyalgia: integrative review sure and family relationship, aggravating psychological factors and performed on devices that use springs for greater assistance or re- influencing quality of life (QL) of the individuals affected by 3it . sistance to movement13. Among the benefits of PM, the following With a still unknown etiology, FMS is a chronic and real pain stand out: improved coordination, flexibility, balance, body awa- syndrome, caused by the sensitization of the central nervous sys- reness, physical conditioning, posture, muscle tone, joint mobi- tem to pain through a disorganized process of nociceptive im- lity, blood circulation, in addition to integrating body and mind, pulses4, like the serotonin neurotransmitters (5HT) and P subs- and can be performed by people of all ages, and with discipline tance, which suffer alterations in their routes and result directly its practitioners can find a fast and effective result in improving in the amplification of pain perception, quality of sleep, mood QL16,17. In this light, despite the benefits of PM being observed in and many other symptoms that are related to FMS5. Yet, FM several conditions, there is a lack of concise knowledge about its may still be easily misunderstood as mood and anxiety disorders, benefits in people suffering from FMS. Consequently, the present which can lead to incorrect diagnosis5. The diagnosis proposed study’s objective was to investigate, if the PM can improve QL and in 1990 by the American College of Rheumatology (ACR)6 ob- pain for people with FMS. Furthermore, the study also intended served the pain sensibility in 11 of the 18 trigger-points (TP) to report the prescription, the variables and tools used in the inter- located throughout the body, associated with generalized pain ventions in order to enlighten the professional that may come to lasting for more than three months. After two decades the ACR work with the PM and FMS. reconsidered the diagnosis through TP and started to advocate the diagnosis through the means of questionnaires and scores, CONTENTS which take into account the clinical symptoms of FMS, like fatigue and cognition problems1. The present study performed an integrative review, which con- Treatment may be pharmacological or not, with the intention of sists in a systematic, ordered, and comprehensive search, leading attenuating pain and the general symptoms related to FMS7. In to a complete synthesis of studies, developing critical thought the non-pharmacological context, physical exercises practice has over the investigate subject and its practice. been recommended as a form of effective treatment on the im- The research was applied in the following databases: Pubmed, Scielo provement of pain, physical function and general well being8,9. and BVS. Associated with the keywords and Booleans, the follo- In that regard, aerobic exercise10, strength training11 or the com- wing terms were used: “exercise movement techniques” OR “Pilates” bination of both1,12 are suggested as interventions more effective OR “Pilates based exercises” OR “Pilates training” AND Fibromy- for the reduction of pain, improvement of QL and lessening of algia. These descriptors should have been present at least in the title, the depression symptoms. abstract or keywords. Studies with clinical or quasi-experimental Through that perspective, the practice of these methods of phy- intervention in English and Portuguese were selected, published un- sical exercise may help patients with FMS through the release of til November 2019. In the studies, the interventions with the PM hormones related to the sensation and modulation of pain and should have been applied, with evaluation of pain and/or QL in the improvement of physical function, like endorphin and seroto- pre and post-intervention periods. Review studies, graduation final nin, providing the patient with a sensation of well being and works, dissertations and thesis were excluded. self control during daily life activities4,9. Nevertheless, some re- After searching for the terms and collecting the studies, a reading searchers4,12 believe that adherence to physical conditioning and of the titles and abstracts was made to assess the adequacy as to the exercise by the people who suffer from FMS is still low, a fact eligibility criteria. From the studies that entered the criteria, the texts that may be related to the ‘’fear of pain induced by inappropriate were read in full, and from those the data was collected (Figure 1). physical exercise’’12. Thus, it’s suggested that the understanding The search returned 35 articles, however, after selection by eligibility of instruction on low impact physical exercises enables more criteria, 5 articles were included, being two pilot studies, one case stu- adherence of this population to the practice. Therefore, although the recommendations for exercise propose ae- Search results robic and strength exercises, other training methods have been in- Pubmed (n=9) BVS (n=25) Scielo (n=1) dicated for patients with FMS, such as the Pilates method (PM)13, with the objective of relieving symptoms. In patients with chronic Excluded articles: non-communicable diseases, the PM has been able to increase Repeated (n=10) Review (n=8) exercise tolerance, attenuate disease symptoms and provide QL to 14 the patients . In patients with chronic lower back pain, the PM Studies potentially included (n=16) reduced pain levels15. In a pilot study conducted with patients with FMS, the PM attenuated pain levels and this seems to have been Studies excluded by related to a lower late muscle pain, low impact and lower produc- title and abstract: tion of peripheral fatigue induced by training14. Compatible intervention: (n=8) The PM is characterized by the philosophy of balance between Incompatible sample: (n=3) body and mind and its principles are concentration, breathing, 13 flow, control, precision and centralization . The PM is divided Included studies (n=5) into free exercises, performed on the ground with the use of mat- tresses, lying down, sitting, standing, or the same exercises but Figure 1. Flowchart of the studies search 259 BrJP. São Paulo, 2020 jul-sep;3(3):258-62 Cordeiro BL, Fortunato IH, Lima FF, Santos RS, Costa MC and Brito AF

Table 1. List of articles resulting from the bibliographical survey Authors Sample Investigated Evaluation Training prescriptions Results variables method Kumpel et 20 W from PG and 20 Quality of life, pain VAS Protocol: PG ↑ Quality of life al.21 from CG (54±5,1 years and quality of sleep FIQ Duration: 8 weeks ↑ Quality of sleep old) PSQS Frequency: 2x/week ↓ Pain Session: 60 min Altan et 49 W from PG (48,2±6,5 Quality of life VAS PG PG al.30 years old) Pain FIQ Protocol: GP ↑ Quality of life 24 from FG (50,0±8.4 Duration: 12 weeks ↓ Pain years old) Frequency: 3x/week Session: 60 min CG Protocol: stretching/relaxation exercises Duration: 12 weeks Frequency: 3x/week Session: 60 min Ekici et 36 W from PG and 15 Quality of life VAS PG PG al.22 from CG (37,13±6,37 Pain FIQ Duration: 4 weeks ↑ Quality of life years old) Points of pain NHP Frequency: 3x/week ↓ Pain 21 from CG Anxiety STAI Session: 60 min. ↓ Anxiety (36.86±7.73 anos) ST: 10 min CG PM: 40 min ↑ Quality of life RL: 10 min ↓ Pain CG Connective tissue massage (CTM) Duration:4 weeks Frequency: 3x/week Session: 5 – 20 min. Komatsu 20 W from PG and 13 Quality of life, pain, VAS PG PG et al.23 from CG (47,85±9,82 anxiety and depres- FIQ Duration: 8 weeks ↑ Quality of life years old) sion BAI Frequency: 2x/week ↓ Pain CG 7 W (53,29±12,27 BDI Session: 60 min. ↓ Anxiety years old) CG ↓ Depression Continued with previous treatment, unchan- ged interventions and therapies Cury and 1 W (63 years old) Quality of life VAS GP and PM and PE exercises PG Vieira24 Pain FIQ Session: 60 min ↑ Quality of life Flexibility Adapted Frequency: 2x/week ↑Flexibility flexitest Duration: 4 weeks ↓Pain Training protocol WU: 5 min GP: 25 min. PE: 25 min RL: 5 min. W = woman; PG = Pilates group; CG = control group; FG = flexibility group; WU = warming up; ST = stretching; PM = Pilates method; GP = ground Pilates; PE = Pilates with equipment; RL = relaxation; VAS = visual analog scale; NHP = Nottingham Health Profile; PSQS = Pittsburg Sleep Quality Score; FIQ = Fibromyalgia Impact Questionnaire; STAI = State-Trait Anxiety Inventory; BAI = Beck Anxiety Inventory; BDI = Beck Depression Inventory.

dy and two clinical trials. Table 1 describes the included articles and Regarding age, the average was 35 to 65 years old, which is similar to their main data related to samples, evaluated variables, evaluation me- the sample of the study20, with an average of 59.7±13.5 years old. thods, prescription of interventions and their main results. As for the investigated variables, all the studies evaluated pain and QL, however, some studies investigated other variables that DISCUSSION are also related to the FMS deficits. In the study21 quality of sleep was evaluated, in two other studies22,23 the researchers assessed The sample found in the studies was exclusively composed of wo- anxiety and, in the study24, flexibility. Although these variables men, a fact that is confirmed by the findings in the literature18, are different from the primary outcome of this review, they are which show that FM affects women six times more than men. all strongly related to the QL25-27. This can be justified because its easier to make the diagnose in For the assessment of pain, all articles used the VAS, which women, since they report the sensation of pain more than men, consists of a 10cm straight line, in which zero corresponds to according to the 1990 ACR’s criteria. Based on the new diagno- no pain and 10 to extremely severe pain. During evaluation, sis criteria, the authors19 assessed the prevalence of 2:1 for the the patient was instructed to point out the level of pain he presence of FM in women in relation to men. However, these was in. A study that sought to verify the effect of resisted results could contain a bias due to the fact that men have more training on pain reduction in women with FM found that the difficulty to report pain in the process of diagnosis20. VAS was the most used instrument in the reviewed articles, 260 Influence of the Pilates method on quality of life and pain BrJP. São Paulo, 2020 jul-sep;3(3):258-62 of individuals with fibromyalgia: integrative review highlighting it as a reliable instrument that has simple appli- In the case report24 the evaluated patient performed the PM on cation and low cost. the ground and with equipments, the training protocol was di- For the assessment of QL, all articles used the Fibromyalgia Im- vided into 5 minutes of warm-up, 25 minutes of ground Pilates, pact Questionnaire (FIQ), a tool specific for the FMS popula- 25 minutes of Pilates with equipments and 5 minutes of relaxation, measuring the influence of the disease on daily activities. tion, twice a week for 4 weeks. It’s composed of 19 questions that encompass the subjects of professional situation, physical symptoms, fatigue, morning stif- Pilates influence on pain fness, pain, quality of sleep, functional capacity, psychological di- As a result, for the variable of pain, all studies presented im- sorders, anxiety, depression and well-being in general. According provement in the pain. Two studies have already verified these to the study29, it’s the most widely used method to evaluate FM improvements shortly after 4 weeks of intervention23,25, showing studies, since it’s validated and reliable. a short-term effect on the mitigation of pain in individuals that Nevertheless, other studies22,30 also used, besides FIQ, the Not- were treated with the PM. Still, it’s worth noticing the impor- tingham Health Profile (NHP), which consists in a questionnaire tance of carrying on the practice. After 12 weeks without the about subjective and autoaplicable health, with six variables: energy, intervention30 pain begins to return to the initial levels reported pain, emotional reactions, sleep, social deprivement and physical in the research, as observed in another study32, which assessed mobility, totaling 38 items that are summed up, obtaining a total pain improvement after a 16 weeks protocol of aquatic physical score of NHP, resulting in the perception of the individual’s QL. In activities in women with FM, but, after 16 weeks without trai- a study31 evaluating the NHP’s reliability after cerebrovascular ac- ning, observed the reduction of this improvement. cident, it was considered reliable, simple and consistent within its In another study33, researchers sought to evaluate the effectiveness domains, making it a good alternative for the assessment of QL in of the PM in reducing chronic pain associated with non-structural adverse health conditions. scoliosis; the result was a 66% decrease in pain. The same was veri- In addition to the variables already mentioned, a study21 evalua- fied with the use of PM in the treatment of lumbar pain, which, by ted sleep through Pittsburg Sleep Quality Score (PSQS), which strengthening the pelvic and central muscles of the body, provided is a questionnaire with 19 items, divided into seven categories: an improvement in pain34. In this sense, it seems that the PM is subjective sleep quality, sleep latency, sleep duration, habitual an effective intervention for the improvement of different aspects sleep efficiency, use of sleeping drugs and daytime dysfunction. of pain, and it can be an adequate alternative for those affected by In two other studies22,23, anxiety was evaluated through State- FMS, a fact observed in the studies found. -Trait Anxiety Inventory (STAI) and Beck Anxiety Inventory The fact that the condition of pain improved may have been (BAI). The study23 evaluated depression through the Beck De- influenced by the physiological effects of exercise on the release pression Inventory (BDI) and the study24 evaluated the level of of hormones such as endorphin and serotonin, which act as mo- flexibility through Flexitest. dulators of opioid receptors, resulting in a hormonal regulation For the intervention methods, duration of protocols found ran- of the pain sensation12. ged from 4 to 12 weeks, with two studies22,24 for 4 weeks, two21,23 for 8 weeks and only one for 12 weeks30. The weekly frequency Pilates influence on quality of life of training was two21,23,24 and three22,30 times per week, with an The results found in all studies of this review observed improve- average duration of 60 minutes for each session. ments related to QL made possible by the PM. One of the studies For prescription, two of the studies21,30 present in this review included23 observed a 14% reduction in the FIQ score, highlighting used the ground PM, performing free exercises, with the use of positive effects in the areas of anxiety, depression, and pain. balls and elastic bands. In the study30 the protocol was divided However, there was an interesting finding in another study30, into 9 modules: postural education, breathing education, neutral whose CG performed stretching activities, but no decrease in position search, sitting exercises, antalgic exercises, propriocep- pain control was observed, a fact that contradicts the study25, tion improvement exercises and stretching exercises. In the con- which observed an improvement in pain with stretching training trol group30 stretching and relaxation exercises were performed at within the same 12 weeks of intervention. home with an exercise protocol that was already used by resear- Regarding other variables, such as anxiety and depression, chers in patients with FMS. which related to QL, it’s important to point out that exercises In two other studies22,23 it was not possible to identify the mode trying to associate mind-body, for example, tai chi, yoga and of PM used, since the authors did not describe it in the arti- Pilates, work not only on the physical body, but also encom- cles. However, one of these studies22 divided its volunteers into 2 pass psychosocial, emotional, spiritual and behavioral charac- groups, Pilates group (PG) and control group (CG). Both groups teristics of the individual, which can be especially beneficial received interventions 3 times a week for 4 weeks. The PG perfor people with FM9. This statement embraces the results fou- formed the Pilates protocol, which was divided into 10 minutes nd in the articles analyzed in the present study, which showed of warm-up, 40 minutes of Pilates exercise and 10 minutes of improvement in depression and anxiety variables22,23. Some re- cooling down. The activity level was gradually increased from 5 searchers30 stated that the Pilates techniques were developed to to 10 repetitions according to the progress of the group. The CG train the body striving for a strong mind, allowing total control received a connective tissue massage (CTM) intervention of 5 to over the body. In another study22, the authors found that pain 20 minutes in each session, depending on the treated area. and anxiety were also correlated. 261 BrJP. São Paulo, 2020 jul-sep;3(3):258-62 Cordeiro BL, Fortunato IH, Lima FF, Santos RS, Costa MC and Brito AF

As for quality of sleep, there was a strong correlation between the 8. Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martín D, Monserrat J, Álvare- z-Mon M. Effectiveness of therapeutic exercise in fibromyalgia syndrome: a systematic review quality and results of the FM impact questionnaire, i.e., the lo- and meta-analysis of randomized clinical trials. Biomed Res Int. 2017;2017:2356346. wer the impact of FM on the individual, the better the quality of 9. Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, et al. Exer- 21 35 cise therapy for fibromyalgia. Curr Pain Headache Rep. 2011;15(5):358-67. sleep . According to some researchers , the practice of PM only 10. Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Góes SM, et al. Aerobic exercise for 4 weeks, 3 times a week, is already enough to improve the training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017;(6):CD012700. quality of sleep. In another study36, which evaluated the effect 11. Busch AJ, Webber SC, Richards RS, Bidonde J, Schachter CL, Schafer LA, et al. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev. 2013;(12):CD010884. of Pilates on the quality of sleep in elderly women, it was found 12. Jones KD, Adams D, Winters-Stone K, Burckhardt CS. A comprehensive review of 46 exer- that after 12 weeks of practice there were significant improve- cise treatment studies in fibromyalgia (1988-2005). Health Qual Life Outcomes. 2006;4:67. 13. Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Comple- ments in the quality of sleep, as well as in anxiety, depression and ment Ther Med. 2012;20(4):253-62. fatigue. All these symptoms are related to FM, which corrobo- 14. Miranda S, Marques A. Pilates in noncommunicable diseases: s systematic review of its effects Complement Ther Med. 2018;39:114-30. rates the idea that long-term practice of the PM can be of great 15. Wells C, Kolt GS, Marshall P, Hill B, Bialocerkowski A. The effectiveness of Pilates exercise applicability in the treatment of FMS. in people with chronic low back pain: a systematic review. PLoS One. 2014;9(7):e100402. 16. Bullo V, Bergamin M, Gobbo S, Sieverdes JC, Zaccaria M, Neunhaeuserer D, et al. The effects of Pilates exercise training on physical fitness and wellbeing in the elderly: a systematic Limitations review for future exercise prescription. Prev Med. 2015;75:1-11. The present review has presented some limitations. The first is the 17. Wasser JG, Vasilopoulos T, Zdziarski LA, Vincent HK. Exercise benefits for chronic low back pain in overweight and obese individuals. PM R. 2017;9(2):181-92. limited number of studies that intervened with the PM in patients 18. McNally JD, Matheson DA, Bakowsky VS. The epidemiology of self-reported fibromyalgia with FMS, as well as the quality of studies found. All of this may in Canada. Chronic Dis Can. 2006;27(1):9-16. 19. Vincent A, Lahr BD, Wolfe F, Clauw DJ, Whipple MO, Oh TH, et al. Prevalence of fibrom- reflect the difficulty of feasibility of interventions in this popula- yalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epi- tion. In addition, the small sample size of the studies may make it demiology Project. Arthritis Care Res. 2013;65(5):786-92. 20. Wolfe F, Walitt B, Perrot S, Rasker JJ, Häuser W. Fibromyalgia diagnosis and biased assess- harder to extrapolate the results found in this review to the entire ment: sex, prevalence and bias. PLoS One. 2018;13(9):e0203755. population with FMS. Moreover, the absence of a prescription me- 21. Kümpel C, Aguiar SD, Carvalho JP, Teles DA, Porto EF. Benefício do método Pilates em thodology in the studies makes it difficult to formalize a prescription mulheres com fibromialgia. ConScientiae Saúde. 2016;15(3):440-7. 22. Ekici G, Unal E, Akbayrak T, Vardar-Yagli N, Yakut Y, Karabulut E. Effects of active/passive recommendation, and further studies will need to expose the struc- interventions on pain, anxiety, and quality of life in women with fibromyalgia: randomized turing of the prescription of the PM. Finally, the studies found here controlled pilot trial. Women Health. 2017;57(1):88-107. 23. Komatsu M, Avila MA, Colombo MM, Gramani-Say K, Driusso P. Pilates training improves compared the PM with not intervened groups, therefore, randomi- pain and quality of life of women with fibromyalgia syndrome. Rev Dor. 2016;17(4):274-8. zed clinical trials are necessary to compare the PM with already 24. Cury A, Vieira WHB. Efeitos do método Pilates na fibromialgia. Fisioter Bras. 2016;17(3):256-60. recommended non-pharmacological interventions, such as aerobic 25. Assumpção A, Matsutani LA, Yuan SL, Santo AS, Sauer J, Mango P, et al. Muscle stretching training, strength training and/or combined training. exercises and resistance training in fibromyalgia: which is better? A three-arm randomized controlled trial. Eur J Phys Rehabil Med. 2018;54(5):663-70. 26. Vancini RL, Rayes ABR, Lira CAB, Sarro KJ, Andrade MS. Pilates and aerobic training CONCLUSION improve levels of depression, anxiety and quality of life in overweight and obese individuals. Arq Neuropsiquiatr. 2017;75(12):850-7. 27. Silvestri J. Effects of chronic shoulder pain on quality of life and occupational engagement The Pilates method can be an alternative for the improvement of in the population with chronic spinal cord injury: preparing for the best outcomes with pain and QL for the FMS public, in which positive results after occupational therapy. Disabil Rehabil. 2017;39(1):82-90. 28. Correia LC, Lima Filho BF, Fontes FP, Varella LRD, Brasileiro JS. Efeito do treinamento only 4 weeks of practice could be observed. However, for the resistido na redução da dor no tratamento de mulheres com fibromialgia: revisão sistemática. permanence of the method’s benefits, it’s necessary to carry on Rev Bras Ciênc Mov. 2018;26(2):170-5. 29. Marques AP, Santos AMB, Assumpção A, Matsutani LA, Lage LV, Pereira CAB. Valida- with the practice. ção da versão brasileira do Fibromyalgia Impact Questionnaire (FIQ). Rev Bras Reumatol. 2006;46(1):24-31. REFERENCES 30. Altan L, Korkmaz N, Bingol U, Gunay B. Effect of Pilates training on people with fibromyalgia syndrome: a pilot study. Arch Phys Med Rehabil. 2009;90(12):1983-8. 31. Cabral DL, Damascena CG, Teixeira-Salmela LF, Laurentino GEC. Confiabilidade do 1. Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American perfil de saúde de Nottingham após acidente vascular encefálico. Cienc Saude Coletiva. College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement 2012;17(5):1313-22. of symptom severity. Arthritis Care Res. 2010;62(5):600-10. 32. Andrade CP, Zamunér AR, Forti M, Tamburús NY, Silva E. Effects of aquatic training and 2. Heymann RE, Paiva EDS, Helfenstein M, Pollak DF, Martinez JE, Provenza JR, et al. Con- detraining on women with fibromyalgia: controlled randomized clinical trial. Eur J Phys senso brasileiro do tratamento da fibromialgia. Rev Bras Reumatol. 2010;50(1):56-66. Rehabil Med. 2019;55(1):79-88. 3. Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome 33. Araújo MEA, Silva EB, Vieira PC, Cader SA, Mello DB, Dantas EHM. Redução da dor measures, and treatment. J Rheumatol Suppl. 2005;75:6-21. Erratum in: J Rheumatol Su- crônica associada à escoliose não estrutural, em universitárias submetidas ao método Pilates. ppl. 2005;32(10):2063. Motriz. 2010;16(4):958-66. 4. Santos LC, Kruel LFM. Síndrome de fibromialgia: fisiopatologia, instrumentos de avaliação 34. Vasconcellos MHO, Silva RDS, Santos SMB, Merlo JRC, Conceição TMA. The Pilates® e efeitos do exercício. Motriz Rev Educ Fís. 2009;15(2):436-48. Method in the treatment of lower back pain. Fisioter Mov. 2014;27(3):459-67. 5. Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014;311(15):1547-55. 35. Aibar-Almazán A, Hita-Contreras F, Cruz-Díaz D, de la Torre-Cruz M, Jiménez-Gar- 6. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The cía JD, Martínez-Amat A. Effects of Pilates training on sleep quality, anxiety, depres- American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. sion and fatigue in postmenopausal women: a randomized controlled trial. Maturitas. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990;33(2):160-72. 2019;124:62-7. 7. Chinn S, Caldwell W, Gritsenko K. Fibromyalgia pathogenesis and treatment options upda- 36. Sivertsen H, Bjørkløf GH, Engedal K, Selbæk G, Helvik AS. Depression and quality of life te. Curr Pain Headache Rep. 2016;20(4):25. in older persons: a review. Dement Geriatr Cogn Disord. 2015;40(5-6):311-39.

262 BrJP. São Paulo, 2020 jul-sep;3(3):263-74 REVIEW ARTICLE

Scales for the assessment of pain in the intensive care unit. Systematic review Escalas para a avaliação da dor na unidade de terapia intensiva. Revisão sistemática

Tássia Catiuscia Nascimento Silva da Hora1, Iura Gonzalez Nogueira Alves1

DOI 10.5935/2595-0118.20200043

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: Pain is an unpleasant JUSTIFICATIVA E OBJETIVOS: A dor é considerada como sensory and emotional experience associated with actual or uma experiência sensorial e emocional desagradável, associada a potential tissue damage or described in terms of such damage. uma lesão efetiva ou potencial dos tecidos. Avaliar a dor é muito Thus, pain is difficult to evaluate, especially in patients under- complexo, principalmente quando se trata de pacientes ventila- going mechanical ventilation in an intensive care unit. However, dos mecanicamente na unidade de terapia intensiva. No entanto, there are several instruments to assess these patients’ pain. Thus, existem diversas escalas para avaliam a dor desses pacientes. Des- the aims of the present study were described and characterize sa forma, este estudo teve como objetivo sumarizar dados acerca the psychometric characteristics of the intensive care unit pain das características psicométricas das escalas de avaliação de dor assessment scales. na unidade de terapia intensiva. CONTENTS: A systematic review in the electronic databases of CONTEÚDO: Foi realizada uma revisão sistemática através da Pubmed, LILACS, Cochrane Library and Scielo was performed, pesquisa nas bases de dados Pubmed, LILACS, Cochrane Library without time restrictions. The focus of this evidence synthesis is e SciELO, foram incluídos os estudos que verificaram a confia- to examine the validity, reproducibility, and responsiveness of in- bilidade, a validade, reprodutibilidade e a capacidade de resposta tensive care unit pain scales. 58 studies were included. Cronbach das escalas de avaliação de dor na unidade de terapia intensiva. alpha ranged from 0.31 to 0.96 and the intraclass correlation Dos 58 estudos incluídos, o alfa de Cronbach variou de 0,31 a coefficient from 0.25 to 1.00. A cross-cultural adaptation was 0,96 e o coeficiente de correlação intraclasse variou de 0,25 a performed in 28 studies for use in language Portuguese (Brazil), 1,00. Houve adaptação transcultural de 28 estudos nas versões Chinese, Italian, Swedish, Portuguese (Portugal), English, Dut- brasileira, chinesa, italiana, sueca, portuguesa, inglesa, holande- ch, Turkish, Persian, Danish, Polish, Spanish and Greek. sa, turca, persa, dinamarquesa, polonesa, espanhola e grega. CONCLUSION: Among the available scales to measure pain in CONCLUSÃO: Os estudos publicados até o momento demons- non-responsive patients, the data is not enough to indicate the supe- traram uma lacuna para indicar a superioridade entre as escalas riority between them. In Brazil, most studies demonstrated that the que avaliam dor em pacientes em ventilação mecânica. No Brasil, pain scales had satisfactory validity, reliability, and reproducibility a maior parte dos estudos ressaltou que as escalas de avaliação da rates. Thus, when deciding which scale to use, the convenience of dor apresentam índices de validade, confiabilidade e reprodutibi- application and familiarity of the team should be considered. lidade satisfatórios. Assim, a decisão entre a escala a ser utilizada Keywords: Critical care, Intensive care units, Pain measurement, deve considerar facilidade de aplicação e a familiaridade da equipe. Reproducibility of results. Descritores: Cuidados críticos, Medição da dor, Reprodutibili- dade dos testes, Unidade de terapia intensiva.

INTRODUCTION

Pain is an unpleasant sensory and emotional experience associa- Tássia Catiuscia Nascimento Silva da Hora – https://orcid.org/0000-0003-2594-3825; ted with actual or potential tissue damage or described in terms Iura Gonzalez Nogueira Alves – https://orcid.org/0000-0003-2455-3788. of such damage1. However, assessing pain is something complex, 1. Centro Universitário Social da Bahia, Pós-Graduação em Fisioterapia Hospitalar em Uni- since the perception of pain involves biological, emotional, so- dade de Terapia Intensiva. Salvador, BA, Brasil. ciocultural, and environmental aspects2,3. Moreover, the inter- Submitted on April 03, 2020 pretation and evaluation of pain are subjective and personal2,4,5. Accepted for publication on May 24, 2020. Intensive care units are prepared to look out for patients in cri- Conflict of interests: none – Sponsoring sources: none tical state or that need constant monitoring, but it’s common Correspondence to: that these patients are submitted to various routine procedures Iura Gonzalez Nogueira Alves Avenida Oceânica, 2717 – Ondina that can promote discomfort and pain. Beyond that, most of 40170-010 Salvador, BA, Brasil the times patients are under mechanic ventilation (MV), using E-mail: [email protected] sedatives or with a lowered consciousness level, and therefore in- © Sociedade Brasileira para o Estudo da Dor capable of reporting their experience of pain6. 263 BrJP. São Paulo, 2020 jul-sep;3(3):263-74 Hora TC and Alves IG

Nowadays there are various scales for measuring pain in in- levant studies. Each abstract was independently evaluated by two tensive care units (ICU), such as the Behavioral Indicators of reviewers. If at least one reviewer considered a reference as eligib- Infant Pain (BIIP), Behavior Pain Assessment Tool (BPAT), le, the article was obtained in its entirety. The two authors inde- Behavioral Pain Scale (BPS), Critical-Care Pain Observation pendently reviewed the articles and selected those that would be Tool (CPOT), COMFORT Behaviour Scale, Faces – Legs – included in the review. In case of disagreement, the decision was Activity – Cry and Consolability Scale (FLACC), Nonverbal made by consensus of the authors. A manual citation tracking Pain Scale (NVPS), COVERS Scale, Pain Assessment Tool was also performed on the selected articles. (PAT), Behavioural Indicators of Pain Scale (ESCID), Multidi- mensional Objective Pain Assessment Tool (MOPAT), Visual Selection of studies and extraction of data Analog Scale horizontal (VAS-H) and vertical (VAS-V), Verbal A first evaluation was made based on the title and abstract of the Descriptor Scale (VDS), Numeric Rating Scale Oral (NRS-O), articles, excluding those that did not meet the inclusion criteria. NRS visually enlarged laminated (NRS-V), Neonatal Pain As- After that, the articles, collected through database searches, were sessment Scale, Neonatal Infant Pain Scale (NIPS), Premature read in their entirety. Infant Pain Profile (PIPP), Nepean Neonatal Intensive Care First, all the selected articles were read. After that, the parts that Unit Pain Assessment Tool (NNICUPAT), Nonverbal Pain As- were really of interest were read selectively and analytically. The sessment Tool (NPAT), FACES, Numeric Rating Scale (NRP) information extracted from the articles was recorded to sort and e Crying – Requires Oxygen – Increased Vital Signs – Expres- summarize the material, so that relevant information to the re- sion and Sleepless (CRIES). However, despite the variety of search could be obtained. instruments published in the scientific literature, many profes- For the extraction of results, a table was developed by the authors sionals are unaware of their availability and the methodological in order to extract the characteristics and results of the studies, re- aspects for their use in clinical practice. gistering the following information: author(s); country/langua- More recent studies, including guidelines, reinforce the necessity ge; studied population; mean age; sample; scales used; reliability of the evaluation of pain as a routine for patients in the ICU with values; validity; responsiveness and reproducibility/equivalence. the objective of improving clinical outcomes7-9. To this end, scales are necessary and it’s essential that professionals that are going Data synthesis to use these instruments on their daily care of patients have a Since the present study’s data are not adequate for a collection in good knowledge of the scales available, as well as the aspects rela- meta-analysis, they were combined through narrative synthesis, ted to their validity, reliability and reproducibility. and the result consistency and study homogeneity information The present study aims at synthesizing data about the psychome- were presented. tric characteristics of the available pain scales for the ICU. Methodological quality analysis CONTENTS The checklist proposed by COSMIN risk-bias (Consensus-based Standards for the Selection of Health Measurement Instruments) A systematic review meeting the criteria of the Reporting Guide was used to assess the quality of the studies. The COSMIN risk- for JBI Systematic Reviews (JBISRIR) was performed10. -bias checklist consists of nine measurement properties. All original studies that assessed validity, reproducibility and/or reliability of the pain scales for ICU usage in adults and children RESULTS were considered. The search was not restricted by language or year of publication and was executed during the period of July The search strategy resulted in 241 articles. From these, 58 stu- 2019 to April 2020 in the following databases Pubmed, LILA- dies met the eligibility criteria and were included in this study. CS, Cochrane Library e Scielo. The mnemonic PICO was used Figure 1 shows the flowchart regarding the studies selection. to define the inclusion criteria for this review. From the 58 included studies, 42 articles aimed at verifying the reliability, validation, reproducibility, and responsiveness of sca- Search strategy les individually, while 16 articles verified the psychometric pro- The initial search strategy was composed of four keywords, ac- perties of two or more scales in a single study. cording to the investigation question (mnemonic PICO) (P: The total sample of participants in all studies was 8.122 in- patients, C: construct and O: outcome - measurement proper- dividuals, 7.787 of whom were adults and 335 children. In ties)10-12. The keywords used were described from the Medical 15 studies14-23.25-28 the number of men and women was not Subject Headings (MeSH) and Descritores em Ciências da Saúde informed (Table 1). From the 58 articles, 36 informed the (DeCS - Health Sciences Descriptors) search terms, in which Cronbach’s Alpha, which ranged from 0.3129 to 0.9630.31. The ICU patients, critical care and their synonyms were included. intraclass correlation coefficient (ICC) ranged from 0.2528 to For construct, the measurement of pain and synonyms was used, 1.0032 and 19 articles did not inform the studies’ ICC (Tables for outcome, the reproducibility of results and their synonyms 2, 3 and 4). were used. In Brazil, two scales were validated for the Portuguese language, An experienced reviewer performed the search and initial selec- BPS and CPOT. Thus, four studies evaluated the psychometric tion in order to identify the titles and abstracts of potentially re- properties exclusively of BPS6,37,42,54 and another of BPS and 264 Scales for the assessment of pain in the intensive BrJP. São Paulo, 2020 jul-sep;3(3):263-74 care unit. Systematic review

CPOT34 (Table 3). From the four studies conducted in Brazil 6,54 Records identified Additional records that evaluated BPS, two of them found Cronbach’s alpha coef- through database identified through ficient below 0.6, showing low reliability. searching (n=245) other sources (n=0) In the other two studies37,42 that evaluated BPS, the Cronbach’s Alpha values were 0.8 and the ICC varied from 0.7 to 0.95. Indentification Records after duplicates removed It’s important to note that all studies done in Brazil reported (n=241) the execution of a transcultural validity. The rest of the studies that validated BPS outside of Brazil found values between 0.64 to 0.86, which results in a consistency between weak and good. Records screened Records excluded ICC varied from 0.50 to 1.0, obtaining results considered satis- Screening (n=58) (n=0) factory to excellent. Regarding the validity of CPOT in Brazil, only one study per- Full-text articles Full-text articles formed it and CPOT was evaluated with BPS34. No signifi- assessed for excluded, with cant differences between the pain measurement properties of eligibility (n=58) reasons (n=0) the two scales were found37,42. Both presented good validity

Eligibility indexes. It should be noted that the authors made a transcultu- Studies included ral validity for Brazilian Portuguese. Studies around the world in qualitative 17-20,29,36,39,45,46,51,52,57,66,67 synthesis (n=58) that evaluated CPOT separetly identified Cronbach coefficient values varying from 0.31 to 0.89 and Studies included in ICC from 0.53 to 0.99. Comparisons between CPOT and BPS outside Brazil32,40,43,49,55 also showed no differences between the

Included quantitative synthesis (meta-analysis) (n=0) two scales. For the other pain assessment scales, no Brazilian study was fou- Figure 1. Flowchart of the article selection process nd. Thus, a brief description of the results is presented below.

Table 1. Description of the characteristics of the included studies Authors Country Patients Sample Scales Hylén et al.33 Sweden Adults n=57 (63% men and 37% women) BPS Kaya and Erden26 Turkey Adults n=74 NVPS Sulla et al.14 Italy Children n=09 BPS Klein et al.34 Brazil Adults n=168 (88 men and 80 women) BPS - CPOT Pudas-Tähkä and Salanterä30 Finland Adults n=06 (04 men and 02 women) BPS - CPOT - NVPS Fagioli et al.35 Italy Children n=35 (17 boys and 18 girls) COMFORT Shan et al.36 China Adults n=400 (235 men and 165 women) CPOT Dionysakopoulou et al.31 Greece Newborns n=81 (44 boys and 37 girls) NIPS - PIPP Ribeiro et al.37 Brazil Adults n=27 (25 men and 02 women) BPS Wiegand et al.38 United States Adults n=27 (13 men and 14 women) MOPAT Sulla et al.20 Italy Adults n=50 CPOT Kotfis et al.39 Poland Adults n=71 (50 men and 21 women) CPOT Chookalayia et al.18 Iran Adults n=65 CPOT Rijkenberg et al.40 Netherlands Adults n=72 (52 men and 20 women) BPS - CPOT Cheng et al.32 China Adults n=113 (73 men and 40 women) BPS - CPOT Gélinas et al.41 28 countries Adults n=3851 (60,8% men and 39,2% women) BPAT Azevedo-Santos et al. 42 Brazil Adults n=25 (10 men and 15 women) BPS Hylén et al.15 Sweden Adults n=20 BPS Severgnini et al.43 Italy Adults n=101 (64 men and 37 women) BPS - CPOT Al Darwish, Hamdi and Saudi Arabia Adults n=47 (27 men and 20 women) BPS - CPOT - NVPS Fallatah44 O’Sullivan et al.16 New Zealand Children n=80 COVERS - PAT Aktas and Karabulut45 Turkey Adults n=66 (48 men and 18 women) CPOT Latorre-Marco et al.23 Spain Adults n=190 ESCID Continue...

265 BrJP. São Paulo, 2020 jul-sep;3(3):263-74 Hora TC and Alves IG

Table 1. Description of the characteristics of the included studies – continuation Authors Country Patient Sample Scales Frandsen et al.46 Denmark Adults n=70 (44 men and 26 women) CPOT Joffe et al.19 Canada Adults n=79 CPOT Chen et al.47 China Adults n=53 (26 men and 27 women) BPS Rahu et al.48 United States Adults n=150 (78 men and 72 women) NVPS - BPS - FACES - FLACC - COMFORT - NRP Azevedo-Santos et al. 6 Brazil Adults n=15 (12 men and 03 women) BPS Liu, Li and Herr49 China Adults n=117 (84 men and 33 women) BPS - CPOT Boitor, Fiola and Gélinas17 Canada Adults n=125 CPOT Latorre-Marco et al.22 Spain Adults NI ESCID Navarro-Colom et al.50 Spain Adults n=34 (22 men and 12 women) BPS Li et al.51 China Adults n=63 (39 men and 29 women) CPOT Echegaray-Benites, Kapoustina Canada Adults n=43 (22 men and 21 women) CPOT and Gélinas52 Chanques et al.53 United States Adults n=30 (11 men and 19 women) BPS - CPOT - NVPS Morete et al.54 Brazil Adults n=100 (61 men and 39 women) BPS Rijkenberg et al.55 Netherlands Adults n=68 (41 men and 27 women) BPS - CPOT Topolovec-Vranic et al.56 Canada Adults n=66 (36 men and 30 women) CPOT - NVPS Linde et al.57 NI Adults n=30 (23 men and 07 women) CPOT Batalha et al.58 Portugal Adults n=60 (42 men and 18 women) BPS Rivas, Rivas and Bustos59 Chile Newborns n=112 (69 boys and 43 girls) NIPS Chen et al.60 China Adults n=70 (51 men and 19 women) BPS Nurnberg Damstrom et al.29 Sweden Adults n=40 (21 men and 19 women) CPOT Marmo and Fowler21 United States Adults n=24 CPOT - NVPS - FLACC Chanques et al.61 France NI n=111 (74 men and 37 women) VAS-H - VAS-V - VDS - NRS-O – Voepel-Lewis et al.62 United States Adults and Chil- n=29 (17 men and 12 women) NRS-V dren n=08 (04 boys and 03 girls)* *Data about gender absent in one of the FLACC children Klein et al.24 Guinea-Bissau Adults n=270 NPAT Chanques et al.63 France Adults n=30 (20 men and 10 women) BPS Johansson and Kokinsky64 Sweden Children n=40 (22 boys and 18 girls) COMFORT - FLACC (modified) Kabes, Graves and Norris25 United States Adults n=121 NVPS Holsti et al.65 Canada Preemies n=69 (36 boys and 33 girls) BIIP Gélinas and Johnston66 Canada Adults n=55 (32 men and 23 women) CPOT Gélinas et al.67 Canada n=105 (83 men and 22 women) CPOT Adults Young et al.68 Australia Adults n=44 (26 men and 18 women) BPS Spence et al.27 NI Newborns n=144 PAT McNair et al.28 Canada NI n=51 PIPP - CRIES Marceau69 Australia Newborns n=30 (17 boys e 13 girls) NNICUPAT Payen et al.70 France Adults n=30 (17 men e 13 women) BPS NI: not informed BIIP = Behavioral Indicators of Infant Pain; BPAT = Behavior Pain Assessment Tool BPS = Behavioral Pain Scale; CPOT = Critical-Care Pain Observation Tool; FLACC = Faces - Legs - Activity - Cry and Consolability Scale; COMFORT Behaviour Scale; FACES Scales; NVPS = Nonverbal Pain Scale; COVERS Scale; PAT = Pain Asses- sment Tool; ESCID = Behavioural Indicators of Pain Scale; MOPAT = Multidimensional Objective Pain Assessment Tool; VAS-H = Visual Analog Scale horizontal and VAS-V = vertical; VDS = Verbal Descriptor Scale; NRS-O = Numeric Rating Scale Oral; NRS-V = Numeric Rating Scale visually enlarged laminated; NPAS = Neonatal Pain Assessment Scale; NIPS = Neonatal Infant Pain Scale; PIPP = Premature Infant Pain Profile; NNICUPAT = Nepean Neonatal Intensive Care Unit Pain Assessment Tool; NPAT = Nonverbal Pain Assessment Tool; NRP = Numeric Rating Scale; CRIES = Crying-Requires Oxygen - Increased Vital Signs - Expression and Sleepless.

266 Scales for the assessment of pain in the intensive BrJP. São Paulo, 2020 jul-sep;3(3):263-74 care unit. Systematic review

Table 2. Measurements properties of validated pain assessment scales in adults Authors Internal consistency Reliability (ICC) Validity Transcultural (Cronbach α) Adaptation Hylén et al.33 NI NI Discriminatory validity Swedish NPP (CI) 0.65 (0.56 - 0.75) Version PP (CI) 0.28 (0.17 - 0.40) Kaya and 0.776 NI Construct validity Turkish Version Erden26 Barlett Test χ2= 105.433 (p<0.001) Pudas-Tähkä BPS: 0.86 BPS: 0.80 NI Swedish, Dutch and Salanterä30 CPOT: 0.96 CPOT: 0.80 and Chinese NVPS: 0.90 NVPS: 0.80 Version Shan et al.36 NI 0.86 to 0.93 Discriminatory validity Chinese Version Wiegand et al.38 0.68 - 0.72 NI p<0.001 NI Sulla et al.20 Intubated patients: 0.78 NI Spearman correlations: Italian Version 0.42 (p<0.05) to 0.99 (p<0.001) Kotfis et al. 39 0.89 > 0.97 Spearman correlations: Polish Version R > 0.85, p<0.0001 Chookalayia 02 examinators Before NPP: 0.98 Discriminatory validity Persian Version et al.18 Before NPP: 0.79 / 0.79 NPP: 0.96 Mann-WhitneyTest: p<0.001 During NPP: 0.66 / 0.67 After PP: 0.99 After NPP: 0.76 / 0.76 Before PP: 0.97 Before PP: 0.59 / 0.64 PP: 0.96 After PP: 0.98 Rijkenberg CPOT 0.74 (0.68 – 0.79) Discriminatory validity by Fried- NI et al.40 Nurse 1: 0.65 P = 0.001 man Nurse 2: 0.58 BPS Nurse 1: 0.62 Nurse 2: 0.59 Cheng et al.32 NI Kappa coefficient: Construct validity: Chinese Version CPOT CPOT Facial expression: 0.64 (0.31 - 0.98) / Wald X2= 22.82 Body movements: 1.00 (1.00 - 1.00) (p<0.05) / Muscle tension: 0.72 (0.43 - 1.00) BPS / Complication with ventilation: 1.00 Wald X2= 19.71 (1.00 - 1.00) (p<0.05) BPS Facial expression: 0.73 (0.46 - 0.99) / Upper limbs: 0.94 (0.86 - 1.00) / Complication with ventilation: 0.80 (0.41 - 1.00) Gélinas et al. 41 NI Kappa: Convergent validity NI Neutral facial expression (0.69) Pearson correlation: Presence of grimace (0.69) r = 0.79 Shivering (0.60) (p<0.001) Eyes closed (0.70) Moans (0.69) Verbal complaints (0.78) Muscle rigidity (0.57) Clenched fists (0.62) Hylén et al.15 NI Kappa: Discriminatory validity by Svens- Swedish > 0.89 son Version NPP: 0.6406 (0.4861 to 0.7951) PP: 0.1020 (0.0000 to 0.2066) Severgnini et NI Kappa: Discriminatory validity NI al.43 Before PP: 0.69 (p<0.0001) PP: 0.64 After PP: 0.66 Al Darwish, BPS: 0.95 BPS: 0.77 NI NI Hamdi and CPOT: 0.95 CPOT: 0.47 and 0.69 (during aspira- Fallatah44 NVPS: 0.86 tion and rotation, respectively) NVPS: 0.72 Continue...

267 BrJP. São Paulo, 2020 jul-sep;3(3):263-74 Hora TC and Alves IG

Table 2. Measurements properties of validated pain assessment scales in adults – continuation Authors Internal consistency Reliability (ICC) Validity Transcultural (Cronbach α) Adaptation Aktas and During PP: 0.72 Kappa Coefficient Discriminatory validity: Turkish Version Karabulut45 After PP: 0.71 0.89 (p=0.001) Pearson: 0.63 (p<0.001) Latorre-Marco 0.85 NI Convergent validity Spanish Version et al.23 r = 0.94 – 0.99 (p<0.001) Frandsen et al. 46 > 0.70 > 0.90 Discriminatory validity Danish Version Spearman Correlations Joffe et al.19 NI 0.727 (95% IC 0.570 - 0,833) Discriminatory validity by NI Friedman: (Chi-square = 150.656, p<0.001) Chen et al.47 Intubated patients: 0.962 – 1.000 Pearson Correlation Chinese Version 0.724 – 0.743 Intubated patients: Not intubated patients: 0.815 – 0.937 0.701 – 0.762 Not intubated patients: 0.755 – 0.899 Rahu et al.48 NVPS: 0.78 NI Spearman Correlations NI BPS: 0.94 NVPS COMFORT: 0.90 NPP: -0.1485 / p=0.35 PP: 0.5594 / p<0.001 BPS NPP: 0.2050 / p=0.19 PP: 0.5557/ p<0.001 FACES NPP: 0.2197 / p=0.18 PP: 0.7613 / p<0.001 FLACC NPP: 0.1072 / p=0.50 PP: 0.6320 / p<0.001 COMFORT NPP: 0.3385 / p=0.03 PP: 0.6527 / p<0.001 Liu et al.49 CPOT: 0.795 NI CPOT Chinese Version BPS: 0.791 Z = - 14.352 p<0.001 BPS Z = -14.440 (p<0.001) Boitor, Fiola and NI Rest: 0,863 Discriminatory validity NI Gélinas17 NPP: 0,956 Mauchly test: Rest:: 0,535 (p<0.001) PP: 0,828 Convergent validity: r = 0.313 (p<0.01) Latorre-Marco 0.70 a 0.80 NI Pearson correlations Spanish Version et al.22 Before the evaluation: 0.97 During the evaluation: 0.94 After the evaluation: 0.95 Navarro-Colom NPP: 0.66 (CI 95% 0.33-0.83) NPP: 0.50 (CI 95%: 0.19 – 0.71) NI NI et al.50 PP: 0.73 (CI 95%: 0.50-0.87) PP: 0.58 (CI 95%: 0.31 – 0.77) Li et al.51 0.59 to 0.86 0.80 to 0.91 Discriminatory validity Chinese Version Spearman correlations: 0.81 to 0.93 Echegaray- NI > 0.75 Wilcoxon Test with Bonferroni NI Benites, correction: Kapoustina and (Z = 5.14, p<0.001) Gélinas52 AUC: 0.864, P < 0.001 (CI 95% = 0.757 – 0.971) Chanques et BPS: 0.80 Kappa: BPS: 0.90 NI al.53 CPOT: 0.81 BPS: 0.81 CPOT: 0.86 NVPS: 0.76 CPOT: 0.81 NVPS: 0.92 NVPS: 0.71 Continue...

268 Scales for the assessment of pain in the intensive BrJP. São Paulo, 2020 jul-sep;3(3):263-74 care unit. Systematic review

Table 2. Measurements properties of validated pain assessment scales in adults – continuation Authors Internal consistency Reliability (ICC) Validity Transcultural (Cronbach α) Adaptation Rijkenberg CPOT: 0.71 CPOT Discriminatory validity by Friedman English Version et al.55 BPS: 0.70 0.75 (0.69 – 0.79) and Wilcoxon p=0.001 BPS 0.74 (0.68 – 0.79) p=0.001 Topolovec- 0.36 to 0.75 0.62 to 0.68 Discriminatory validity by ANOVA NI Vranic et al.56 CPOT: F = 5.81 p=0.019 NVPS-R: F = 5.32 (p=0.25 validity of criteria: 0.59 to 0.71 (p<0.05) Linde et al.57 NI Kappa Coefficient: Competing validity NI 0.87 (CI 95%, 0.79 -0.94) Batalha et al.58 0.65 – 0.73 0.79 (0.67 – 0.87) Construct validity Portuguese 02 examinators Version Facial expression: 0.75 - 0,83 SL movement: 0.90 – 0.92 Ventilator adaptation: 0.83 – 0.71 Chen et al.60 NI NI Pearson correlation: r = 0.50 - 1.00 Chinese Version (p < 0.001) Discriminatory validity by ANOVA (F = 377.7 p<0.001) Nurberg- 0.31 – 0.81 0.84 (0.72 – 0.92) Spearman correlations: Swedish Ver- Damstrom et al.29 0.32 – 0.45 sion Marmo and 0.89 NI Pearson Correlations NI Fowler21 Chanques et NI NI Pearson Correlations NI al.61 Klein et al.24 0.82 NI Construct validity NI (p<0.001) Voepel-Lewis 0.882 0.67 - 0.95 Construct validity NI et al.62 PP: 5.27 SD 2.3 NPP: 0.52 SD 1.1 (p<0.001) Chanques et 0.79 0.57 – 0.59 Discriminatory validity NI al.63 Kappa Coefficient: 0.89 / 0.82 Gélinas and NI Before PP: 0.80 Discriminatory validity by English Version Johnston66 PP: 0.88 RM-MANOVA After PP: 0.92 Pearson coefficient: Before PP: 0.84 (p≤0.05) PP: 0.84 After PP: 0.93 Gélinas et al.67 NI NI Discriminatory validity by ANOVA NI Spearman Correlations 0.49, 0.59 and 0.40 (p≤0.001) Young et al.68 0.64 NI NI NI McNair et al.28 NI Before surgery: 0.60 Convergent validity NI 72 hours after surgery: 0.25 Kabes, Graves Before PP: 0.36 NI Spearman Correlations NI and Norris25 PP: 0.62 135.86 After PP: 0.62 p<0.001 Payen et al.70 NI Kappa Coefficient: NI NI 0.74 (p<0.01) NI = not informed; PP = painful procedure; NPP = non painful procedure; BPS = Behavioral Pain Scale; CPOT = Critical-Care Pain Observation Tool; COMFORT Behaviour Scale; NVPS = Nonverbal Pain Scale; UL = upper limb, ICC = Intraclass correlation coefficient.

269 BrJP. São Paulo, 2020 jul-sep;3(3):263-74 Hora TC and Alves IG

Table 3. Measurement properties of validated pain assessment scales in adults in Brazil Authors Internal consis- Reliability (ICC) Validity Transcultural Adaptation tency (Cronbach) Klein et al.34 NI Kappa coefficient: Predictive validity: Brazilian Version Pressure algometry CPOT CPOT / BPS 0.44 (0.35 – 0.65) 0.96 (0.95 - 0.97) and 0.96 (0.94 - 0.97), BPS (p<0.001), respectively. 0.44 (0.52 – 0.87) Standard care CPOT / BPS 0.96 (0.94 - 0.97) and 0.94 (0.92 - 0.95), (p<0.001), respectively. Ribeiro et al.37 NI 0.95 (0.90 – 0.98) Discriminatory validity by Brazilian Version Kappa:0.70 Friedman and Wilcoxon p<0.0001 Santos et al.42 NPP (0,8) NPP (0,8) Criteria validity: Brazilian Version PP (0,8) PP (0,9) SBP: 0,35 (p=0,86) DBP: -0,83 (P = 0,69) MBP: -0,17 (P = 0,93) HR: -0,30 (P = 0,89) SpO2: 0,11 (P = 0,61) Ramsay: -0,34 (P = 0,10) RASS: 0,32 (P = 0,12) Apache II: -0,03 (P=0,8) Construct validity – hypothesis test (p ≤ 0.0001) Azevedo- Rest (0,42) Rest and PP (0,65) Friedman Test and Tukey Brazilian Version Santos et al.36 NPP (0,53) NPP (0,53) Test PP (0,57) Morete et al.54 0.501 Kappa: 0.740 NI Portuguese Version ICC of 0.807 (CI 95%: 0.727 - 0.866) (Brazil) NI: not informed; PP: painful procedure; NPP: non painful procedure; BPS = Behavioral Pain Scale; CPOT = Critical-Care Pain Observation Tool; SBP = systolic blood pressure; DBP = diastolic blood pressure; MBP = mean blood pressure; HR = heart rate; SpO2 = peripheral oxygen saturation; RASS = Richmond Agitation-Sedation Scale; APACHE = Acute Physiology Health Chronic Evaluation; ICC = intraclass correlation coefficient.

Table 4. Measurement properties of validated pain assessment scales in children Authors Internal consistency Reliability (ICC) Validity Transcultural Adaptation (Cronbach’s α) Sulla et al.14 0.865 NI Discriminatory validity (ROC): 0.995 Italian Version (p<0.001; s.e. = 0.007; C.I. 95%) [0.982; 1.009]) Fagioli et al.35 NPP: 0.81 Kappa: NI Italian Version PP: 0.91 0.558 Dionysakopoulou NIPS: 0.87 - 0.95 > 0.98 Validity of criteria Greek Version et al.31 PIPP: 0.93 - 0.96 O’Sullivan et al.16 COVERS COVERS Spearman: NI NPP: 0.74 NPP: 0.82 r = 0.81 (p=0.001) PP: 0.79 PP: 0.80 PAT PAT NPP: 0.79 NPP: 0.83 PP: 0.85 PP: 0.86 Rivas et al.59 0,78 NI Varimax rotation technique and standardi- NI sation with Kaiser Johansson and NI Kappa coefficient: Competing validity NI Kokinsky64 COMFORT-B 0.76 (p<0.05) 0.71 (0.75 - 0.77) FLACC 0.63 (0.53 – 0.72) Holsti et al.65 NI NI Discriminatory validity by ANOVA NI Spence et al.27 NI 0.84 Pearson Correlations NI 0.76 (p<0.001) Marceau69 NI NI Discriminatory validity by ANOVA NI NI: not informed; PP: painful procedure; NPP: non painful procedure; NIPS = Neonatal Pain Assessment Scale; PIPP = Premature Infant Pain Profile; COVERS Scale; PAT = Pain Assessment Tool; FLACC = Faces - Legs – Activity – Cry and Consolability Scale; COMFORT Behaviour Scale; ICC = intraclass correlation coefficient.

270 Scales for the assessment of pain in the intensive BrJP. São Paulo, 2020 jul-sep;3(3):263-74 care unit. Systematic review

Nonverbal Pain Scale (NVPS), Critical-Care Pain Observa- reliable scale for pain assessment outside of Brazil. The compari- tion Tool (CPOT) and Behavioral Pain Scale (BPS) son between the COVERS Scale and the PAT16 in neonatal ICU Two studies25,26 aimed to review the NVPS. Cronbach coefficient showed that both scales have satisfactory internal consistency, of 0.82 and a construct validity of p<0.001 were found25, favora- 0.74 to 0.79 and 0.79 to 0.85, respectively. The ICC showed ble results for good reliability. good reliability, COVERS – 0.80 to 0.82 and PAT – 0.83 to Three studies30,44,53 compared the reliability of BPS, CPOT and 0.86. No significant differences were found between the scales, NVPS. There were disagreements in the studies to define the best the two were considered reliable and valid. scale. The BPS and CPOT presented better reliability (0.80 and 0.81)53 and better internal consistency (0.81) than the NVPS Behavioural Indicators of Pain Scale (ESCID) and Multidi- (Cronbach coefficient: 0.76 and ICC: 0.71). One study showed mensional Objective Pain Assessment Tool (MOPAT) that NVPS, BPS and CPOT44 are reliable and valid tools, with Two studies22,23 presented the Cronbach coefficient values from a Cronbach coefficient of 0.95 for BPS and CPOT, and of 0.86 0.70 to 0.85 for the Spanish version of ESCID. The validity for NVPS. However, as for pain assessment sensitivity, BPS was measured by Pearson’s correlation was of 0.94 to 0.97 and the considered the best scale, followed by CPOT. The NVPS pre- convergent validity (p<0.001), respectively. In the study that sented consistency p=0.16 to p=0.21. In this sense, good results measured the psychometric properties of MOPAT, the values of were identified in the internal consistency of the three scales, but Cronbach coefficient and validity were considered satisfactory38. CPOT and NVPS were better when compared to BPS (0.96, 0.90 and 0.86, respectively)30. Nevertheless, the three tools were Neonatal Infant Pain Scale (NIPS), Neonatal Pain Assess- considered reliable. A study evaluated the validity and clinical ment Scale (NPAS) and Premature Infant Pain Profile (PIPP) utility of two pain assessment tools, CPOT and NVPS56. The The NPAS59 presented a Cronbach coefficient of 0.78. NIPS and discriminating validity by ANOVA suggests that CPOT is more PIPP in the Greek version are used to measure pain in newborns acceptable than NVPS, however, the two tools present good via- admitted to ICUs. A Cronbach coefficient of 0.87 to 0.95 was bility for use. found for NIPS and of 0.93 to 0.96 for PIPP. The ICC was higher than 0.98 for both, which suggests excellent consistency Faces – Legs – Activity – Cry and Consolability Scale between the scales31. (FLACC), COMFORT, Critical-Care Pain Observation Tool (CPOT) and Nonverbal Pain Scale (NVPS) Premature Infant Pain Profile (PIPP), Crying – Requires The reliability and validity of FLACC was evaluated62 and the Oxygen – Increased Vital Signs – Expression and Sleepless ICC of 0.67 to 0.95 showed high reliability among evaluators. (CRIES) and Nonverbal Pain Assessment Tool (NPAT) The Cronbach coefficient found was 0.88. In this sense, authors35 The comparison of the convergent validity of two scales, PIPP validated the Italian version of the COMFORT Behaviour Scale and CRIES, showed more evident correlation in the first 24 hou- in pediatric ICU. Internal consistency ranged from 0.81 to 0.91 rs after surgery and more divergent correlations from 40 to 72 and the Cohen Kappa coefficient was 0.558, a moderate index. hours after28. Both scales were considered valid for pain assess- In another study, the pain measurement capability of CPOT, ment in neonates in the ICU. The validity of NPAT was evalua- NVPS and FLACC was tested21. CPOT and NVPS had a ted in the study24 and the authors concluded that this tool has Cronbach coefficient of 0.89, which means high reliability. The good validity and reliability among evaluators, with a Cronbach FLACC tool was considered the most widely used tool in practi- coefficient of 0.82. Moreover, it’s an easy-to-use tool that allows ce. The comparison between COMFORT and modified FLACC a standardized approach for assessing pain in adult patients who was performed64 and the ICC found was 0.71 for COMFORT cannot verbalize pain. and 0.63 for FLACC. The concurrent validity (p<0.05) suggests that both scales are reliable for pain assessment. Nepean Neonatal Intensive Care Unit Pain Assessment Tool (NNICUPAT) Behavior Pain Assessment Tool (BPAT) and Behavioral Indi- validity of NNICUPAT for measuring pain in neonatal ICU was cators of Infant Pain Scale (BIIPS) performed and interexaminator reliability showed significant The BPAT scale was considered a reliable and valid instrument correlation, being r = 0.88 and p<0.02. to measure pain in critically ill patients (Kappa coefficient varied from 0.57 to 0.78)41. BIIPS was compared to BPAT in a sin- Nonverbal Pain Scale (NVPS) versus Behavioral Pain Scale gle study65 by the ANOVA method, and BIIPS was considered (BPS) versus FACES versus Legs – Activity – Cry and Con- accurate and valid to measure acute pain in premature infants solability Scale (FLACC) versus COMFORT Behaviour Scale (Pearson’s coefficient of 0.79). versus Numeric Rating Scale (NRS) In a study included in this review48, validity and sensibility of six Pain Assessment Tool (PAT) and COVERS scale scales, NVPS, BPS, FACES, FLACC, COMFORT Behaviour Through a prospective study27, validity of the newborn pain as- Scale and NRS were measured with the objective of comparing sessment tool, PAT, was performed. The interexaminators relia- their psychometric properties on assessing pain in non-commu- bility was 0.84 and Pearson’s correlations were 0.76, p<0.001. nicative patients. The authors concluded that the six tools had It’s possible to conclude that the PAT is considered a valid and moderate to high correlations, confirming their validity for pain 271 BrJP. São Paulo, 2020 jul-sep;3(3):263-74 Hora TC and Alves IG assessment and sensibility for pain response. However, FACES Table 5. Methodological quality of included studies – continuation require attention due to its subjectivity, which can result in in- Authors 1 2 3 4 5 6 7 8 9 terpretation of exaggerated answers. Morete et al.54 NI NI + + + NI NI NI NI The quality classification of the studies included was performed Rijkenberg et al.55 NI NI + + + NI NI + NI by COSMIN (Table 5). Of the 58 studies, 21 did not report 56 internal consistency, 20 did not report reliability, 4 presented Topolovec-Vranic et al. NI NI + NI + NI NI + NI criteria validity and 46 presented construct validity. Linde et al. 57 NI NI NI NI + NI + NI NI Batalha et al.58 NI NI + + + NI NI + NI Table 5. Methodological quality of included studies Rivas, Rivas and NI NI + NI NI NI NI + NI 59 Authors 1 2 3 4 5 6 7 8 9 Bustos Hylén et al. 33 NI NI NI + NI NI NI + NI Chen et al.60 NI NI NI + NI NI NI + NI Kaya and Erden26 NI NI + + NI NI NI + NI Numberg-Damstrom NI NI + + + NI NI + NI et al.29 Sulla et al.14 NI NI + + NI NI NI + NI Marmo and Fowler21 NI NI + NI NI NI NI + NI Klein et al.34 NI NI NI + + NI + NI NI 61 Pudas-Tähkä and NI NI + + + NI NI NI NI Chanques et al. NI NI NI NI NI NI NI + + Salanterä30 Voepel-Lewis et al. 62 NI NI + NI + NI NI + NI Fagioli et al.35 NI NI + + + NI NI NI NI Klein et al.24 NI NI + NI NI NI NI + NI Shan et al. 36 NI NI NI + + NI NI + NI Chanques et al.63 NI NI + NI + NI NI + + 37 Ribeiro et al. NI NI NI + + NI NI + NI Johansson and NI NI NI NI + NI + NI NI Dionysakopoulou et al.31 NI NI + + + NI + NI NI Kokinsky64 Wiegand et al.38 NI NI + NI NI NI NI + NI Kabes, Graves and NI NI + NI NI NI NI + NI Norris25 Sulla et al.20 NI NI + + NI NI NI + NI Holsti et al.65 NI NI NI NI NI NI NI + NI Kotfis et al. 39 NI NI + + + NI NI + NI 66 Chookalayia et al.18 NI NI + + + NI NI + NI Gélinas and Johnston NI NI NI + + NI NI + NI 67 Rijkenberg et al.40 NI NI + NI + NI NI + NI Gélinas et al. NI NI NI NI NI NI NI + NI Cheng et al. 32 NI NI NI + + NI NI + NI Young et al.68 NI NI + NI NI NI NI NI + Gélinas et al.41 NI NI NI NI + NI NI + NI McNair et al.28 NI NI NI NI + NI NI + NI Azevedo-Santos et al. 42 NI NI + + + NI NI + NI Marceau69 NI NI NI NI NI NI NI + NI Hylén et al. 15 NI NI NI + + NI NI + NI Payen et al. 70 NI NI NI NI + NI NI NI NI Severgnini et al.43 NI NI NI NI + NI NI + NI 1.Content validity; 2. Structural validity; 3. Internal Consistency; 4. Transcultu- ral validity; 5. Reliability; 6. Measurement and reproducibility error; 7. Criteria Al Darwish, Hamdi and NI NI + NI + NI NI NI + validity; 8. Hypothesis test for construct validity; 9. Responsiveness; NI: not Fallatah44 informed. O’Sullivan et al.16 NI NI + NI + NI NI + NI Aktas and Karabulut45 NI NI + + + NI NI + NI Latorre-Marco et al.23 NI NI + + NI NI NI + NI DISCUSSION Frandsen et al.46 NI NI + + + NI NI + NI Joffe et al.19 NI NI NI NI + NI NI + NI Although the assessment and measurement of pain is difficult in critically ill patients, it should be performed in a valid and Chen et al. 47 NI NI + + + NI NI + NI reliable way to provide pain control, if necessary. Therefore, 48 Rahu et al. NI NI + NI NI NI NI + NI to use pain assessment scales in clinical practice, professionals Azevedo-Santos et al. 6 NI NI + + + NI NI + + need to know the tools’ potential for measurement errors, as Liu et al.49 NI NI + + NI NI NI + NI well as the potential they have to provide the necessary infor- Boitor, Fiola and NI NI NI NI + NI NI + NI mation with accuracy and reproducibility. Gélinas17 Previously released reviews and guidelines for the manage- Latorre-Latorre-Marco NI NI + + NI NI NI + NI ment of pain in the ICU71-74 report the importance of using et al. 22 behavioral scales to assess the patient’s pain. These studies Navarro-Colom et al.50 NI NI + NI + NI NI NI NI reinforce the importance of pain assessment tools and their Li et al.51 NI NI + + + NI NI + NI use by physiotherapists and other health professionals in Echegaray-Benites, NI NI NI NI + NI NI + NI ICUs. In addition to these studies, the newest written clinical Kapoustina and practice guideline7 highlights that pain assessment and mana- Gélinas52 gement strategies for critically ill patients should be adopted, Chanques et al.53 NI NI + NI + NI NI + + emphasizing clinical applicability and awareness of professio- Continue... nals on the importance of measuring pain. 272 Scales for the assessment of pain in the intensive BrJP. São Paulo, 2020 jul-sep;3(3):263-74 care unit. Systematic review

Standard tools for pain assessment and new trends for mea- REFERENCES suring pain in patients under MV, such as pupilometry, skin conductivity and bispectral index (BIS), are already described 1. Merskey H, Bogduk N. Part III: pain terms, a current list with definitions and notes on usage. Pain. 1994;2(3):209-14. 72,75-78 in the literature for pain assessment in those patients . 2. Skrobik Y, Ahern S, Leblanc M, Marquis F, Awissi DK, Kavanagh BP. Protocolized in- However, there is more scientific information about the beha- tensive care unit management of analgesia, sedation, and delirium improves analgesia and subsyndromal delirium rates. Anesth Analg. 2010;111(2):451-63. vioral scales for measuring pain in the ICU compared to these 3. Vervest AC, Schimmel GH. Taxonomy of pain of the IASP. Pain. 1988;34(3):318-21. new methods71,74-77. Additionally, the use of scales is still a 4. Bastos D, Silva G, Bastos I, Teixeira L. Dor. Rev Soc Bras Psicol Hosp. 2007;10(1):86-96. 5. 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274 BrJP. São Paulo, 2020 jul-sep;3(3):275-9 REVIEW ARTICLE

Effect of mesenchymal stem cells on the regeneration of structures associated with temporomandibular joint: narrative review Efeito de células-tronco mesenquimais na regeneração das estruturas associadas à articulação temporomandibular: revisão narrativa

Caren Serra Bavaresco1,2,3, Thiago Kreutz Grossmann4, Daniela Seitenfus Rehm3, Eduardo Grossmann5

DOI 10.5935/2595-0118.20200044

ABSTRACT ciated structures in both animal and human models. However, due to the small number of studies and their heterogeneity, the BACKGROUND AND OBJECTIVES: Temporomandibular results presented should be evaluated sparingly. disorders are the problems involving the masticatory muscles Keywords: Stem cells, Temporomandibular joint disc, Temporo- and/or the temporomandibular joint and, among them, the mandibular joint disorders. bone and joint disc degenerative processes stand out. However, an effective treatment for these cases has not yet been identified RESUMO in the literature. Thus, the primary objective of this study was to evaluate the reparative potential of mesenchymal stem cells on JUSTIFICATIVA E OBJETIVOS: As desordens temporoman- degenerative changes in structures associated with the temporo- dibulares constituem-se em um termo coletivo de problemas que mandibular joint in humans and animal models. envolvem os músculos mastigatórios e/ou a articulação tempo- CONTENTS: This narrative review included intervention trials in romandibular. Dentre esses, destacam-se os processos degenera- humans and animals that presented as an outcome variable the re- tivos ósseos e do disco articular, contudo, ainda não foi identi- pair of joint discs and/or temporomandibular joint. The following ficado na literatura um tratamento eficaz para esses casos. Dessa databases were used: Pubmed, LILACS, Scielo and Google Scholar. forma, o objetivo desse estudo foi avaliar o potencial reparador Titles and abstracts were analyzed for the pre-selection of articles das células-tronco mesenquimais sobre as alterações degenerati- potentially eligible for inclusion in this review. The information col- vas das estruturas associadas à articulação temporomandibular lected from each article was included in a specific spreadsheet for em humanos e em modelos animais. this purpose containing the year of publication, article title, author’s CONTEÚDO: Foram incluídos ensaios de intervenção em hu- name, study location, type of study, methodology, results, and con- manos e em animais que apresentassem como variável desfecho o clusions. Two human studies and four animal studies were selected reparo dos discos articulares e/ou da articulação temporomandibu- to compose the narrative review. In all studies presented, the pre- lar. Foram realizadas buscas nas seguintes bases de dados: Pubmed, sence of stem cells was able to improve the clinical, histological, and LILACS, Scielo e Google Acadêmico. Os títulos e resumos foram morphological parameters of the temporomandibular joint. analisados para a pré-seleção dos artigos potencialmente elegíveis CONCLUSION: The use of stem cells seems to be effective in para sua inclusão. As informações coletadas de cada artigo foram treating degenerative changes in temporomandibular joint asso- incluídas em planilha específica para essa finalidade contendo o ano de publicação, título do artigo, nome do autor, local do estudo, tipo de estudo, metodologia, resultado e conclusões. Foram selecionados 2 estudos em humanos e 4 estudos em animais para Caren Serra Bavaresco – https://orcid.org/0000-0002-0730-3632; Thiago Kreutz Grossmann – https://orcid.org/0000-0003-2681-4128; compor este estudo. Em todas essas pesquisas apresentadas, a pre- Daniela Seitenfus Rehm – https://orcid.org/0000-0003-2378-1359; sença de células-tronco foi capaz de melhorar parâmetros clínicos, Eduardo Grossmann – https://orcid.org/0000-0001-7619-3249. histológicos e morfológicos da articulação temporomandibular. 1. Universidade Luterana do Brasil, Porto Alegre, RS, Brasil. CONCLUSÃO: O uso de células-tronco parece ser eficaz no 2. Grupo Hospitalar Conceição, Saúde Comunitária, Porto Alegre, RS, Brasil. tratamento das alterações degenerativas das estruturas associadas 3. Associação Brasileira de Odontologia, Disfunção Temporomandibular e Dor Orofacial, Porto Alegre, RS, Brasil. à articulação temporomandibular. Todavia, devido ao reduzido 4. Hospital Santa Casa Misericórdia, Porto Alegre, RS, Brasil. número de estudos e sua heterogeneidade, os resultados apresen- 5. Universidade Federal do Rio Grande do Sul, Anatomia, Porto Alegre, RS, Brasil. tados devem ser avaliados com parcimônia. Submitted on April 12, 2020 Descritores: Células-tronco, Disco da articulação temporoman- Accepted for publication on June 01, 2020. dibular, Transtornos da articulação temporomandibular. Conflict of interests: none – Sponsoring sources: none Correspondence to: INTRODUCTION Caren Serra Bavaresco Rua Mariz e Barros 219 90690-390 Porto Alegre, RS, Brasil. Temporomandibular disorders (TMD) are the problems in- E-mail: [email protected] volving the masticatory muscles and/or the temporomandi- © Sociedade Brasileira para o Estudo da Dor bular joint (TMJ). Pain, clicking and jaw limitation form 275 BrJP. São Paulo, 2020 jul-sep;3(3):275-9 Bavaresco CS, Grossmann TK, Rehm DS and Grossmann E the classic triad of TMD symptoms, which may be related Evidence also suggests the existence of MSCs associated with to the masticatory muscles, the pre-auricular area or both1,2. synovial fluid obtained from patients undergoing TMJ ar- The most common subtypes include muscular and joint pain, throcentesis14. Moreover, recent studies suggest that the use mainly the joint disc displacements and the degenerative joint of stem cells in animal models of inflammatory pain, neuro- diseases2. Epidemiological studies have shown that 20-50% pathic pain and pain associated with cancer produce powerful of the population presented at least one symptom associated analgesic effects13. to TMD2. From the perspective that an effective treatment for cases When the conservative alternatives for the treatment of joint al- of degeneration of TMJ-associated structures and the tissue terations are not effective, the disease may progress, resulting in forming and analgesic potential of MSCs has not yet been the modification of the bone structures and the joint disc. The identified in the literature, the primary objective of this study mechanism of the pain phenomenon is not yet completely clear, was to assess the repair potential of MSCs on degenerative but it’s known that when the synovial membrane of the TMJ changes in structures associated with TMJ in human and ani- is damaged, lots of inflammatory cytokines are produced and mal models. secreted into the synovial liquid, promoting the degenerative and painful process, which can largely vary for each patient3. CONTENTS The joint surfaces of the TMJ are composed of the temporal bone, the mandibular fossa, the joint tubercle, and the man- A literature review using the Pubmed, LILACS, Scielo and Goo- dibular condyle (MC). The scaly part of the temporal bone gle (gray literature) databases was performed. The search strate- is part of the formation of the zygomatic arch and the TMJ, gy was divided to make the selection of articles more sensitive. including in its extension the mandibular fossa and the joint For the search in humans, the following descriptors were used: tubercle, which acts as a bulkhead for the mandibular condyle ((“temporomandibular joint” [MeSH Terms] OR (“temporo- during movement4. mandibular”[All Fields] AND “joint”[All Fields]) OR “temporo- From the anatomical point of view, the MC is mediolaterally mandibular joint” [All Fields]) AND (“stem cells”[MeSH Terms] longer than in the anteroposterior direction, forming an ellipse OR (“stem”[All Fields] AND “cells”[All Fields]) OR “stem cells” in the transversal plane. The fibrous connective tissue extends to [All Fields])) AND “humans” [MeSH Terms]. For the search on the periphery of the disc, fixating the joint disc to the mandibu- animals, the following were used: ((“temporomandibular join- lar condyle below and to the temporal bone above. Anteriorly t”[MeSH Terms] OR (“temporomandibular”[All Fields] AND and posteriorly, the MC connects to the TMJ disc through the “joint” [All Fields]) OR “temporomandibular joint” [All Fields]) capsular ligaments, while mediolaterally, it connects to the disc AND (“stem cells” [MeSH Terms] OR (“stem” [All Fields] AND via collateral ligaments. This arrangement ensures close contact “cells” [All Fields]) OR “stem cells” [All Fields])) AND “animals” between the disc and the MC during joint movement4. [MeSH Terms:noexp]. The TMJ disc is featured as a fibrocartilage and is located bet- Manual search strategies were performed in the reference list ween the MC and the temporal bone, providing the mandibular of publications included in the study. Titles and abstracts were rotation and traverse movements5. The extracellular matrix of analyzed for pre-selection of articles that were potentially eligible the joint disc is composed by a mesh of type 1 collagen, which for inclusion in the study. represents 80-90% of its dry weight5, and glycosaminoglycans The articles which were included performed animal or human (GAGs), which represent up to 10% of its weight6. Approxima- intervention trials and presented as an outcome variable the re- tely two thirds of its cells are fibroblasts, while one third have a pair of TMJ discs and/or bone structures using MSCs. Literature morphology similar to chondroblasts7. review studies, in vitro studies, subcutaneous studies and those Although the functions and mechanical properties of the TMJ that did not present the outcome variable were excluded. No res- joint disc are already well described, its biomechanical charac- trictions regarding the period of publication of the manuscript teristics in inflammatory and degenerative processes are still un- were included, except in the case of Google Scholar, where the clear3,5,8. In this context, the study9 highlights that both the joint search was conducted in the last 3 years in order to identify the disc and synovial membrane can undergo degenerative processes most recent studies. The information collected for the qualitative after chronic inflammatory processes. analysis were authors, year, place of publication, methodology, Chondrocyte death caused by apoptosis or necrosis is considered results and conclusions. a central feature in clinical or experimental osteoarthritic patho- 527 articles using the stipulated descriptors to evaluate the logy. Several therapies were applied with the intention of recove- effectiveness of MSC use in the regeneration of ATM-related ring the joint injury presented in animal models, but they were structures in humans were found. Of these, 52 were found not able to stimulate local chondrocyte proliferation10. through Pubmed and 475 through Google Scholar. No articles Mesenchymal stem cells (MSC) are multipotent cells present in were found in LILACS and Scielo databases. After reading the a wide variety of tissues. They are a source of tissue originating titles and abstracts, 3 articles were selected for full reading, as from the mesoderm, such as bone, cartilaginous and adipose tis- shown in figure 1. Of these, only 2 were included for qualitati- sue. These cells are capable of adopting a fibroblast morpholo- ve analysis, totaling 41 patients (28 women and 13 men), with gy and, under special conditions, differentiate into adipocytes, ages ranging from 23 to 47 years old. The studies originated chondrocytes and osteocytes11-13. from Brazil and Italy. 276 Effect of mesenchymal stem cells on the regeneration of structures BrJP. São Paulo, 2020 jul-sep;3(3):275-9 associated with temporomandibular joint: narrative review

For animal studies, 330 articles were found, 65 in Pubmed and were excluded, leaving 4 articles for full reading. The studies were 265 in Google Scholar. No articles were found in LILACS and conducted in Finland, Egypt, China, United States, and Italy. Scielo databases. After reading the titles and abstracts, 14 articles The data was tabulated and presented in table 1 (human studies) were selected for full reading, as shown in figure 2. Of those, 10 and table 2 (animal studies).

Records identified Additional records Records identified Additional records through database identified through through database identified through searching (n=527) other sources (n=0) searching (n=330) other sources (n=0) Identification Identification

Records after duplicates removed Records after duplicates removed (n=0) (n=0) Screening Screening Records screened Records excluded Records screened Records excluded (n=52) (n=49) (n=65) (n=51)

Eligibility Articles selected for Records excluded Eligibility Articles selected for Records excluded full-text reading (n=3) (n=1) full-text reading (n=14) (n=10)

Studies included Studies included

Included in qualitative Included in qualitative synthesis (n=2) synthesis (n=4)

Figure 1. Flowchart for the selection of articles on humans Figure 2. Flowchart for the selection of articles on animals

Table 1. Presentation of the studies on human included in the review Authors and country Methodology Results Conclusions de Souza Tesch et One 27-year-old male patient presenting All evaluated clinical parameters sho- Promising results with the use of al.14 Brazil resorption of the mandibular condyles, wed significant improvements, wi- stem cells. mainly on the right side. thout the presence of adverse events. Tissue used to obtain stem cells: nasal Through CT, the presence of new cor- septum. tical and subcortical bone formation Evaluation of the temporomandibular joint in the right TMJ, reduction of the joint structures (TMJ) by computed tomogra- space and partial recovery of the ana- phy (CT). tomy of the mandibular condyle and Variables evaluated: joint pain, maximum temporal bone could be observed. mouth opening, joint noises. Follow-up time: 1 week; 2 weeks; 1 month; 3 months; 6 months; 1 year. Carboni et al.15 Forty patients (28 women and 12 men) Improved parameters in both groups. The use of stem cells seems to Italy with intra-joint alterations, divided into 2 The test group showed better clinical be a promising alternative for the groups: test group (arthrocentesis + stem results regarding pain reduction and treatment of TMJ disorders. cells) and control group (arthrocentesis + mouth opening amplitude. saline solution). Age varied between 23 Regarding the repair of the joint struc- and 47 years old. tures, only in the test group the almost Tissue used to obtain stem cells: adipose. complete repair of joint disc morpho- Evaluation of TMJ structures through nu- logy and capsular ligaments was ob- clear magnetic resonance (NMR) served. Variables assessed: joint pain, headache, cervical pain, tinnitus, brachialgia, dizziness, joint noises, maximum mouth opening. Follow-up period: 1 week; 1 month; 3 months; 6 months.

277 BrJP. São Paulo, 2020 jul-sep;3(3):275-9 Bavaresco CS, Grossmann TK, Rehm DS and Grossmann E

Table 2. Presentation of the studies on animal included in the review Authors and country Methodology Results Conclusions Ahtiainen et al.16 Ten animals submitted to the removal of the joint disc Increase of 7 to 14 times in the expres- The use of dif- Finland bilaterally. discs inserted in the anterior portion of the sion of the molecules of agercan and type ferentiated stem condyle of the mandible. I and type II collagen in the test group af- cells improved Control Group (right side). ter 6 and 12 months, respectively. the morpho- Test group (left side): containing the polylactic discs Regarding bone morphology, it was pos- logical pattern with stem cells (DCT). sible to observe, in the test group, a of bone and joint Evaluation time: 6 months (5 animals) and 12 months greater calcification in the mandibular disc. (5 animals). condyle and temporal bone, as well as a Evaluated measurements: Radiological evaluation reduction in the number of microcyst. (cone beam tomography); Histology (hematoxin and In histological analysis, the joint cartilage eosin or Masson’s trichrome); Gene expression of the in the test group seemed more regular extracellular matrix components of fibrocartilage at when compared to the control group. implantation. Ciocca et al.17 A sheep. Preparation of stem cell supports mediated The analysis of bone formation showed a Increased bone Italy using CAD-CAM. statistically significant difference between the regeneration of The stem cells were derived from the bone marrow of test group and the control group (p<0.05). up to 79.7% after the iliac crest and the platelets were obtained from the The bone growth values showed a sig- the application of sheep’s venous blood. nificant difference between mandibular stem cells. Evaluation time: 4 months condyles with and without the presence Evaluated measurements: histological and histomor- of stem cells (p<0.05). The mandibular phometric evaluation. condyle of the test group showed greater bone formation. Zhang et al.18 Rats of the lineage C57BL/6J UACS caused bone matrix loss and anky- The use of stem China Bone marrow cells marked with green fluorescent pro- losis. The weekly injections of stem cells cells was able to tein (GFP-CTM) were injected weekly into the TMJ, star- largely restored these changes. reverse the de- ting after 3 weeks of unilateral anterior crossbite stimula- The implanted stem cells expressed a generative pro- tion (UACS) and continuing for 4, 8 and 12 weeks. high level of CD163 protein but showed cesses caused Another group stopped receiving injections for 4 no remarkable cell proliferation. The ter- by the UACS. weeks after 8 weeks of injections. mination of the supply of exogenous stem Evaluated measurements: DAP3, CD163 and ki67 ex- cells reversed the restorative effects. pression. Zaki et al.19 Fifty rabbits were divided into three groups: Group I The TMJs of subgroup III, treated with Stem cells can Egypt (n=10) did not receive treatment. Group II (n=20) was combined therapy, showed improvement be used safely divided into 2 subgroups according to the type of treat- in all tested parameters. and effectively to ment. One subgroup (n=10) received an intra-joint in- repair degenera- jection (IJ) of saline solution (PBS) and the other (n=10) tive changes in received an IJ injection of PBS plus stem cells. Group the TMJs. III (n=20) received an oil emulsion injection before treatment with PBS or PBS plus stem cells as in group II. The rabbits were sacrificed after the third week and the joints were histologically processed.

DISCUSSION cord and, more recently, the nasal septum14. During the in vitro growth, MSCs form colonies called fibroblastic colony forming After the critical reading of the studies, it was possible to identify units (CFU-F). The phenotypic characterization of these cells the promising results for the MSCs in humans and animal mo- reveals the expression of CD44, CD29, CD105, CD73 and dels on the clinical, histological, and morphological perspectives. CD166 and the absence of hematopoietic lineage markers such The tissue engineering has been searching for substances as CD45 and CD3421. that could substitute the removed discs, including autoge- Several therapeutic alternatives have been proposed for the re- nous substances as the temporal muscle dermis and fascia, cuperation of the function and the improvement of the clinical as well as the synthetic materials produced from silicone and parameters in individuals that presented joint alterations. In this polytetrafluorethane. Over the last decades, the autologous context, the joint disc changes are classified into 4 stages with chondrocytes implantation (ACI) has developed rapidly. Ho- progressive characteristics: a) Joint disc displacement. Stage 1: wever, the limited speed of cell proliferation and chondrocyte joint disc displacement with reduction; Stage 2: joint disc dis- differentiation during in vitro cultures has restricted the use placement with reduction and intermittent closed locking; Stage of ACI 20. 3: joint disc displacement without reduction (closed locking); On the other hand, MSCs have become the object of increasing Stage 4: joint disc displacement without reduction with evidence study in this area due to their high proliferative capacity, lower of joint disc perforation or degenerative joint disease22. Thus, it cost, and lower morbidity to the donor site20. Its attainment has became clear that therapeutic approaches must be related to the been associated with the tooth pulp, adipose tissue, umbilical severity of the alteration presented by the patient and its clinical 278 Effect of mesenchymal stem cells on the regeneration of structures BrJP. São Paulo, 2020 jul-sep;3(3):275-9 associated with temporomandibular joint: narrative review implication, with MSCs joint infiltration being another promi- REFERENCES sing treatment for these diseases22. Regarding the evidences presented in the two human studies, 1. Okeson JP, de Leeuw R. Differential diagnosis of temporomandibular disorders and other orofacial pain disorders. Dent Clin North Am. 2011;55(1):105-20. the improvement of clinical parameters could be observed, as 2. Ohrbach R, Dworkin SF. The evolution of TMD diagnosis: past, present, future. J well as the presence of bone repair assessed through imaging exa- Dent Res. 2016;95(10):1093-101. 3. 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However, there is a belief that growth factors pain. Front Immunol. 2017;8:1014. β β 14. de Souza Tesch R, Takamori ER, Menezes K, Carias RBV, Dutra CLM, de Freitas such as tumor growth factor 1 (TGF- 1) and the family of Aguiar M, et al. Temporomandibular joint regeneration: proposal of a novel treatment bone morphogenetic proteins (BMPs) are directly involved in for condylar resorption after orthognathic surgery using transplantation of autolo- this process23. Moreover, the authors25 have demonstrated that gous nasal septum chondrocytes, and the first human case report. Stem Cell Res Ther. 2018;9(1):94. the Wnt pathway regulation promotes the repair of cartilages 15. Carboni A, Amodeo G, Perugini M, Arangio P, Orsini R, Scopelliti D. Temporo- mediated by the presence of MSCs. mandibular disorders clinical and anatomical outcomes after fat-derived stem cells injection. J Craniofac Surg. 2019;30(3):793-7. As for the reduction of pain and inflammatory process, several 16. 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279 BrJP. São Paulo, 2020 jul-sep;3(3):280-4 REVIEW ARTICLE

Financial stress and pain, what follows an economic crisis? Integrative review Estresse financeiro e dor, o que surge após uma crise econômica? Revisão integrativa

Maurício Kosminsky1, Michele Gomes do Nascimento1, Gabriela Neves Silva de Oliveira1

DOI 10.5935/2595-0118.20200048

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: Numerous epidemio- JUSTIFICATIVA E OBJETIVOS: Inúmeros estudos epidemiological studies have investigated the relationships of socioecono- lógicos têm investigado as relações entre fatores socioeconômicos mic factors and pain perception. These studies mainly emphasize e a percepção da dor. Esses estudos enfatizam principalmente issues related to family income. The impact of specific economic questões relacionadas à renda familiar. O impacto de questões issues on the individual and their relationship to pain has not econômicas específicas sobre o indivíduo e sua relação com a dor been well studied. The purpose of this review is to evaluate the não têm sido bem avaliados. O objetivo deste estudo foi avaliar impact of financial stress on pain symptoms, considering how it se o estresse financeiro interfere nos sintomas da dor, conside- interacts and contributes to pain experience, regardless of its type rando como ele interage e contribui para a experiência da dor, and chronicity. independentemente de seu tipo e cronicidade. CONTENTS: After pandemics, a global economic crisis often CONTEÚDO: Após pandemias, muitas vezes surge uma crise eco- emerges, with relevant implications in populations’ health. An nômica global, com implicações relevantes para a saúde das popula- integrative review was carried out, with searches developed in ções. Realizou-se uma revisão integrativa, com pesquisas desenvolvidas Medline (via Pubmed), LILACS (via BVS), Scielo and PsycINFO nas bases de dados Medline (via Pubmed), LILACS (via BVS), Scielo databases, limited to Portuguese, Spanish and English languages, e PsycINFO, limitadas às línguas portuguesa, espanhola e inglesa, e and no restriction for publication year. The PICO methodology sem restrição para ano de publicação. A metodologia PICO foi uti- was used to select descriptors from the research question. Selec- lizada para selecionar os descritores da questão da pesquisa. Também tion and eligibility criteria were also established according to this foram estabelecidos critérios de seleção e elegibilidade, de acordo com strategy. The final review sample consisted of nine articles. tal estratégia. A amostra final da revisão consistiu em nove artigos. CONCLUSION: This review identified that financial stress re- CONCLUSÃO: Identificou-se que o estresse financeiro repre- presents a risk factor for several pain-related parameters, such as senta um fator de risco para vários parâmetros relacionados à dor, the prevalence of chronic pain, intensity and frequency of pain, como a prevalência de dor crônica, intensidade e frequência de use of pain drugs and interference in daily activities. This is a dor, uso de fármacos para o controle da dor e interferência nas fundamental issue, and its recognition can direct the professional atividades diárias. Trata-se de uma questão fundamental, e seu to a broader and more effective treatment line. reconhecimento pode direcionar o profissional a uma linha de Keywords: Chronic pain, Economics, Pain, Psychological stress. tratamento mais ampla e eficaz. Descritores: Dor, Dor crônica, Economia, Estresse psicológico.

INTRODUCTION

The economic crisis caused by COVID-19 reached countries of all development ranges in many sectors of their economies. Accor- ding to the World Trade Organization (WTO) and the Organiza- Maurício Kosminsky – http://orcid.org/0000-0003-3111-7837; tion for Economic Cooperation and Development, this pandemic  Michele Gomes do Nascimento – https://orcid.org/0000-0003-2175-7080; 1 Gabriela Neves Silva de Oliveira – https://orcid.org/0000-0002-2146-4387. poses a huge threat to the global economy . In times of economic difficulty, health may be suddenly affected by new demands. It is 1. Universidade de Pernambuco, Centro de Controle da Dor Orofacial, Recife, PE, Brasil. estimated that the cost fo pain treatments may soon exceed the Submitted on March 26, 2020. expenses related to heart disease or cancer2. In times of economic Accepted for publication on June 18, 2020. difficulty, the population’s need for pain control is also increased3. Conflict of interests: none – Sponsoring sources: none. Due to the temporal proximity of the current pandemic, its eco- Correspondence to: nomic implications and health repercussions cannot be precisely Gabriela Neves Silva de Oliveira Rua José Nunes da Cunhas, nº 4546 determined. However, comparisons with past events can identify 54440-030 Jaboatão dos Guararapes, PE, Brasil. its potential harmful effects4. In the beginning of the decade, E-mail: [email protected] Europe was deeply affected by an economic crisis, producing a © Sociedade Brasileira para o Estudo da Dor negative impact on people’s painful behaviour5. 280 Financial stress and pain, what follows an BrJP. São Paulo, 2020 jul-sep;3(3):280-4 economic crisis? Integrative review

Economic security is defined as the capability of individuals, households or communities to cover their essential needs in Records identified Additional records a sustainable and dignified manner6. Food, housing, clothing, through database identified through hygiene products, health and education associated costs en- searching (n=440) other sources (n=10) 7 compass items regarded as “essential needs” . When these needs Identification cannot be met, financial difficulties can become a form of stress Records after duplicates on people’s lives. removed (n=443) Financial stress (FS) is a condition in which a company or individual cannot generate income because it is unable to meet or Records Records cannot pay its financial obligations. FS can be classified in two screened excluded Screening distinct forms: chronic FS, associated with a lower socioecono- (n=443) (n=424) mic level, and acute FS, resulting from financial incidents8. The first is related to continuous tensions that do not present imme- Full-text articles diate resolution prospects, the latter refers to acute daily events9. assessed for Full-text articles eligibility (n=19) Economic crisis can trigger one or both events. excluded (n=10) FS due to pandemics’ economic crisis has an impact on indivi- Eligibility Studies included dual’s health, markedly in the more vulnerable countries. Given Did not measure pain in qualitative (n=4) that the literature has been recently focusing on this topic, the synthesis (n=9) present review aims to evaluate FS impact on pain symptoms, Did not measure considering how it interacts and contributes to pain experience, Studies included in financial difficulties regardless of its type and chronicity. (n=6)

Included quantitative synthesis (meta-analysis) (n=0) CONTENTS Figure 1. PRISMA flow diagram for inclusion of articles10 This integrative review followed the recommended steps: 1. elaboration of the guiding question, 2. establishment of inclusion where studies were developed, the distribution was: United Sta- and exclusion criteria, 3. critical analysis of the included studies, tes (4), Germany (2), Singapore (1), Japan (1) and Greece (1). and 4. extraction, synthesis and presentation of data10,11. The re- Studies samples ranged from 200 to 7560 participants. search question was: “Is there any effect of FS or financial diffi- Among the selected articles, the majority was cross-sectional culties on pain?”. A comprehensive search was conducted using eight, the remaining study was a cohort (1). Six different FS the following databases: Medline, (via Pubmed), LILACS (via instruments were identified. Most studies applied specific BVS), Scielo and PsycINFO until May 2020. surveys to participants (4). The retrieved studies evaluated a Search terms were defined according to the PICO methodolo- diverse range of financial difficulties. Among them, resources gy (Patient, Intervention, Comparison and Outcomes) and infor daily expenses and necessities, over-indebtedness, subjec- cluded, primarily: FS, over-indebtedness and pain, with related tive economic hardship, and ability to afford basic needs. One terms in all fields. Limits were set to include only quantitative study did not specify the type of financial difficulty studied. studies of adults written in the English, Portuguese or Spanish To assess exposure to FS, the most frequent instrument was languages, with no publication period limits. Reference lists of studies-specific surveys, developed by the authors. In some retrieved sources were also searched. The search was performed studies, FS exposure was collected through databases of debt with the following keywords: ‘financial stress’, ‘financial difficul- advisory agencies. ties’, ‘financial burden’, ‘financial strain’, ‘financial hardships’, Regarding the investigation of painful conditions, most stu- ‘over-indebtedness’ and ‘pain’ combined by Boolean operators dies addressed musculoskeletal pain, both acute and chronic. OR/AND (pain), OR (pain perception), OR (acute pain), OR One study evaluated specifically cervical pain and two investi- (chronic pain), AND “financial stress”, OR “financial burden”, gated oncological pain. Pain-related outcomes included daily OR “financial strain”, OR “financial hardships”, OR “financial intensity and/or by period, impact of pain on function, fre- difficulties”, OR “over-indebtedness”. quency of pain and use of pain control drugs. To measure the In order to be included in the final review, each article was scree- painful condition, the studies used several instruments and ned for the following inclusion criteria: original papers investiga- scales. The McGill questionnaire was reported in 2 studies. ting FS among young or older adults and its effect on pain. Lite- The Brief Pain Inventory was also cited by two studies. Two rature reviews, dissertations, thesis, studies where the results were other studies used numerical scales. The remained studies not well established, or articles not related to the theme were analysed data from different databases, however they were not excluded. The search strategy process is presented on figure 1. specified. The final search yielded 9 studies. Regarding the publication All studies included in the present review found an association years, most studies had been carried out in the last 5 years. The between FS, financial difficulties, or indebtedness with higher distribution was one article for the years of 2009, 2011, 2016, pain scores, regardless of pain type or population studied. The 2020, two for 2018 and three for 2019. Regarding countries results are presented in table 1. 281 BrJP. São Paulo, 2020 jul-sep;3(3):280-4 Kosminsky M, Nascimento MG and Oliveira GN

Table 1. Studies distribution according to authors, design, measurements, and pain-related outcomes Authors Design FS Pain FS Pain assessment Pain assessment Outcomes Evans Cross-sectio- Resources for Chronic pain Specific survey McGill Pain Financial difficulties were associated et al.12 nal basic Questionnaire with chronic pain (r=0.29** p=0.000) necessities Evans Cross-sectio- Resources for Pain intensity Specific survey McGill Pain Financial difficulties were correlated with et al.13 nal basic Questionnaire pain intensity. necessities Individuals with higher financial difficulties reported more pain intensity (p<.01). Warth Comparative Over-indeb- Several pain Debt advisory OID-survey Over-indebtedness significantly increa- et al.3 cross-sectio- tedness criteria centres sed the odds of pain after adjustment nal DEGS1 (aOR 1.30; 95%-CI1.07–1.59).The over- -indebted were significantly less likely to use pain drug compared to the general population after adjustment (aOR 0.76; 95%-CI0.58–0.99). Malhotra et Cross-sectio- Resources for Pain interfe- Americans Re- Brief Pain Inven- A higher financial difficulties score was al.14 nal daily expen- rence in daily sources and tory associated with worse physical outco- ses activities Services ques- me (i.e. greater total pain and suffering) tionnaire (p<0.05). Batistaki et Prospective Self-percep- Pain intensity Specific survey Numeric Scale Most patients (97.5%) believed that the al.5 cross-sectio- tion of the cri- intensity of their pain would have been nal sis intensity improved if their financial status had been better. Sekiguchi Cohort Financial diffi- New-onset Survey of Li- Comprehensive A significantly higher rate of new-onset et al.15 culty self-per- neck pain ving Condi- Survey of Living neck pain was observed in participants ception tions Conditions who considered their subjective economic hardship to be “hard” (OR 1⁄4 2.10, 95% CI 1⁄4 1.34-3.30) or “very hard” (OR 1⁄4 3.26, 95% CI 1⁄4 1.83-5.46; p<0.001) compared to those who considered their hardship to be “normal”. Lathan Retrospective Financial Pain severity Quality of Life Brief Pain Inven- Compared to patients with more than 12 et al.16 cross-sectio- reserves in Questionnaire tory months of financial reserves, those with nal months limited financial reserves reported significantly increased pain (adjusted mean difference, 5.03 [95% CI, 3.29 to 7.22] and 3.45 [95% CI, 1.25 to 5.66]) Rios and Prospective Ability to af- Daily pain in- Specific survey Numeric Scale The interaction between daily financial Zautra17 cross-sectio- ford basic tensity worry and economic hardship was signal needs nificant. This effect was statistically significant after controlling for the influence of level 2 control variables (economic hardship, age, neuroticism, diagnostic group and working status). (β = .47, SE .23, p .04). Ochsmann Cross-sectio- Over-indeb- Presence of Debt counse- OID-survey Being overindebted was identified as an et al.18 nal tedness back pain ling agencies independent effect modifier and was associated with higher odds of suffering from back pain (aOR:10.92, 95%CI: 8.96 - 13.46). aOR = adjusted odds ratios; CI = confidence intervals; FS = financial stress; DEGS1: Germany (2008–2011); OID-survey: Germany (2017).

DISCUSSION individual perceives his/her economic condition16. In the consul- ted literature, only 9 articles reporting association or correlation To the authors, this review is the first to comprehensively syn- between FS and pain experience were found. These studies have thesize the published evidence on painful conditions and expo- consistently demonstrated that this type of stress is associated sure to FS. All studies included in this review have established with several pain conditions. a relationship between socioeconomic status and pain. Family A multilevel analysis study found that daily financial worry was income is an assessment that commonly reflects the socioecono- associated with daily pain, and also that economic hardship mo- mic condition of an individual or a group of individuals. On the derates the effects of daily financial worry on daily pain. Financial other hand, the FS construct is a subjective measure of how the worry led to significantly more pain among those who rated their 282 Financial stress and pain, what follows an BrJP. São Paulo, 2020 jul-sep;3(3):280-4 economic crisis? Integrative review financial situations as more stressful. Those with high economic form of prevention, school curricula should introduce content hardship experienced the most pain on days with high finan- related to financial education. cial worry, those with a mid-range level of economic hardship This review has some limitations. Firstly, most studies were cross- experienced more moderate effects of daily financial worry on sectional. However, even if causality may not be assumed pain, and those with low economic hardship appeared not to between FS and pain, they provide an overall representation of experience any impact of daily financial worry on pain. These the characteristics or frequency of the targeted data point, at findings indicated there was evidence of considerable variation any given time, which makes them a useful opportunity when between individuals in the relation between daily financial worry determining the allocation of resources to the population. and pain17. Secondly, because FS was determined in a variety of ways, its It’s important to notice that “family income”, frequently emplo- prevalence may be underestimated, and it becomes difficult to yed in studies to evaluate socioeconomic status and pain, may extrapolate these findings to the general population. Finally, not be adequate to assess an individual’s real economic difficul- unrelieved or chronic pain is a disabling condition and it also can ties, since it does not reflect financial obligations or debts. One alter family dynamics and increase FS or the number of health- particular study found a daily temporal association between FS care visits. Therefore, longitudinal studies are recommended to and higher pain perception during that day13. It’s important to identify the temporal relation between exposure to FS and pain, highlight that individuals with family income related to the lo- preventing misconceptions. wer social stratum may have reduced levels of FS. On the other Future studies should identify different types of FS, establishing hand, individuals with family income associated with higher so- a score for standardization of new research, as well as include dra- cial stratum may exhibit a high level of FS due to the presence wings that may allow to understand how FS interferes in psycho- of excessive debts. logical, social, and physiological variables, altering the percep- From this perspective, financial debts are reported as related to tion of pain. One of the strengths of this review was the use of various health problems, particularly those related to mental the rigorous methodology provided by study11 for conducting an health14. Pain is likewise a more frequent experience in indivi- integrative review. Also, multiple re-checks of the source articles duals with debts3 and even small debts can amplify pain percep- were performed at several stages of the analysis process to avoid tion15. In accordance to that, two studies found that economic erroneous premature conclusions. crisis are associated with an increase in pain prevalence5,16. The- refore, after a global economic crisis, a phenomenon of indebted- CONCLUSION ness may occur18, where higher pain scores should be expected in individuals financially impacted by pandemics. This review identified that FS represents a risk factor for several The studies included in this review analysed FS in different ways. pain related parameters, such as prevalence of chronic pain, Some of them reported information about the financial reser- pain intensity, frequency of pain, pain drugs usage and pain ve in the past year16, conditions available for health treatments, interference in daily activities. Whereas pain is a multifactorial housing and other obligations5, resources for basic needs such phenomenon, there must be comprehensive knowledge of a as food or public accounts12,13,17, level of indebtedness3,18, assess- patient’s economic status, including over-indebtedness and ment of chronic financial difficulties15, and questionnaires deve- difficulty of paying essential monthly items. This is a fundamental loped by the authors5,12,13,17. Regardless, all pain parameters were issue and its recognition can extend the professional awareness to associated with FS exposure. a broader and more effective treatment line. In 2016, one study developed among a sample of 5343 cancer patients found that a large number of individuals were prone REFERENCES to report their FS, suggesting that this variable can be used as 16 1. Chakraborty I, Maity P. COVID-19 outbreak: migration, effects on society, global a routine during clinical evaluation . Questioning about FS environment and prevention. Sci Total Environ. 2020;728:138882. seems to be less inconvenient than the inquiry of family in- 2. Henschke N, Kamper SJ, Maher CG. The epidemiology and economic consequences come, as FS is found in all social strata, thus causing less em- of pain. Mayo Clin Proc. 2015;90(1):139-47. 3. Warth J, Puth MR, Tillmann J, Porz J, Zier U, Weckbecker K, Muster E. Over-inde- barrassment in the provision of information. 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10. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting cancer: results from the COMPASS study. Support Care Cancer. 2019;12 [Epub ah- items for systematic reviews and meta-analyses: the PRISMA statement. PLoSMed. ead of print]. 2009;6(7):e1000097. 15. Sekiguchi T, Hagiwara Y, Sugawara Y, Tomata Y, Tanj F, Watanabe T, et al. Influence 11. Souza MT, Silva MD, Carvalho R. Revisão integrativa: o que é e como fazer. Einstein. of subjective economic hardship on new onset of neck pain (so-called: katakori) in 2010;8(1 Pt 1):102-6. the chronic phase of the Great East Japan Earthquake: A prospective cohort study. J 12. Evans MC, Bazargan M, Cobb S, Assari S. Mental and physical health correlates of Orthop Sci. 2018;23(5):758-64. financial difficulties among African-American older adults in low-income areas of Los 16. Lathan CS, Cronin A, Tucker-Seeley R, Zafar SY, Ayanian JZ, Schrag D. Association Angeles. Front Public Health. 2020;8:21. of financial strain with symptom burden and quality of life for patients with lung or 13. Evans MC, Bazargan M, Cobb S, Assari S. Pain intensity among community-dwelling colorectal cancer. J Clin Oncol. 2016;34(15):1732-40. African American older adults in an economically disadvantaged area of Los Angeles: social, 17. Rios R, Zautra AJ. Socioeconomic disparities in pain: the role of economic hardship behavioral, and health determinants. Int J Environ Res Public Health. 2019;16(20):3894. and daily financial worry. Health Psychol. 2011;30(1):58-66. 14. Malhotra C, Harding R, Teo I, Ozdemir S, Hoh GCH, Neo P, et al. Financial difficul- 18. Ochsmann EB, Rueger H, Letzel S, Drexler H, Muenster E. Over-indebtedness and ties are associated with greater total pain and suffering among patients with advanced its association with the prevalence of back pain. BMC Public Health. 2009;9:451.

284 BrJP. São Paulo, 2020 jul-sep;3(3):285-7 CASE REPORT

Photobiomodulation as an adjuvant in the pharmacological treatment of trigeminal neuralgia. Case report Fotobiomodulação como adjuvante no tratamento farmacológico da neuralgia trigeminal. Relato de caso

João Paulo Colesanti Tanganeli1, Denise Sabbagh Haddad2, Sandra Kalil Bussadori1

DOI 10.5935/2595-0118.20200042

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: Trigeminal Neuralgia JUSTIFICATIVA E OBJETIVOS: A neuralgia trigeminal pro- causes intense suffering and impaired quality of life. The diag- voca intenso sofrimento e comprometimento da qualidade de nosis is clinical. Thermography has been proven to be a useful vida. O diagnóstico é clínico. A termografia tem se mostrado tool, both for confirming and monitoring this neuralgia. Photo- uma ferramenta útil tanto para a confirmação quanto para o biomodulation is being increasingly well documented, specially acompanhamento dessa neuralgia. A fotobiomodulação está cada when associated with the first-choice therapy, which is pharma- vez mais bem documentada, em especial quando associada com cotherapy. In this case report, the objective was to investigate the a terapia de primeira escolha, que é a farmacoterapia. O objetivo performance of the laser, associated with anticonvulsants, in a deste estudo foi investigar a atuação do laser, associado a anticon- patient with trigeminal neuralgia, considering its results from a vulsivante, em paciente com neuralgia trigeminal, considerando clinical and thermographic point of view. os seus resultados sob o ponto de vista clínico e termográfico. CASE REPORT: Male patient, 62 years old, presenting idiopa- RELATO DO CASO: Paciente do sexo masculino, 62 anos, thic trigeminal neuralgia, diagnosed 4 years before, being con- portador de neuralgia trigeminal idiopática, diagnosticado há 4 trolled with oxcarbazepine (600mg), divided in 2 daily doses, anos, sendo controlado com oxcarbazepina (600mg), dividida being the dose doubled in the last year. In the last 4 months, the em 2 doses diárias, sendo esta dose dobrada no último ano. Nos symptoms worsened with the increase in the drug dosage, gene- últimos quatro meses os sintomas se agravaram com o aumen- rating side effects not supported by the patient. Photobiomodu- to da dose do fármaco, gerando efeitos adversos não suportados lation was proposed as a complementary treatment, with infrared pelo paciente. Foi proposta a fotobiomodulação como tratamen- thermography being performed before and after treatment. After to complementar, sendo realizada a termografia infravermelha the low-intensity laser therapy protocol, there was a significant antes e depois do tratamento. Após o protocolo de laserterapia improvement, demonstrated both by the patients report and the de baixa intensidade, houve melhora significativa, demonstrada thermography, maintaining this result in the 6-month control. tanto pelo relato do paciente quanto observado pela termografia, The dosage was reduced to 300 mg/day, restoring quality of life. mantendo-se esse resultado no controle de seis meses. O fármaco CONCLUSION: Low-intensity infrared laser photobiomodula- foi reduzido para 300mg/dia, o que devolveu ao paciente a qua- tion can be extremely useful when associated with an appropriate lidade de vida. drug in the control of idiopathic trigeminal neuralgia, both in CONCLUSÃO: A fotobiomodulação por laser de baixa intensi- the immediate and medium-term outcome. dade infravermelho pode ser extremamente útil quando associa- Keywords: Laser therapy, Thermography, Trigeminal Neuralgia. da a um adequado fármaco no controle da neuralgia trigeminal idiopática, tanto no resultado imediato quanto a médio prazo. Descritores: Neuralgia do trigêmeo, Terapia a laser, Termografia. João Paulo Colesanti Tanganeli – https://orcid.org/0000-0002-8022-6987; Denise Sabbagh Haddad – https://orcid.org/0000-0001-7053-0881; Sandra Kalil Bussadori – https://orcid.org/0000-0002-9853-1138. INTRODUCTION

1. Universidade Nove de Julho, Programa de Pós-Graduação em Biofotônica Aplicada às Ciências da Saúde, São Paulo, SP, Brasil. Trigeminal neuralgia (TN) is a disease that involves the cranial 2. Universidade de São Paulo, Departamento de Estomatologia, Disciplina de Radiologia, pair V, presenting intense, paroxysmal, and short duration pain. São Paulo, SP, Brasil. The patients report electric shock pain, frequently resulting from Submitted on January 21, 2020. non-nociceptive stimulus, like chewing, combing hair, brushing Accepted for publication on May 13, 2020. teeth, shaving or even soft touches on the determined area, a Conflict of interests: none – Sponsoring sources: none phenomenon known as allodynia. The person suffering from Correspondence to: TN usually goes through several healthcare professionals until João Paulo Colesanti Tanganeli Rua Cotoxó, 303 cj 86 – Perdizes the correct diagnosis is obtained. In this scenario, the dentist 05021-000 São Paulo, SP, Brasil. is often the first professional to be sought and has a key role E-mail: [email protected] [email protected] in differential diagnosis regarding dental pain. Several iatrogenic © Sociedade Brasileira para o Estudo da Dor procedures are frequently performed, such as endodontics and 285 BrJP. São Paulo, 2020 jul-sep;3(3):285-7 Tanganeli JP, Haddad DS and Bussadori SK unnecessary exodontics, which can even worsen the patient’s si- nerve, and along the lower alveolar nerve part of the trigeminal tuation. According to the International Classification of Heada- mandibular branch, extra oral and intra oral path region of the che Disorders (ICHD), established by the International Heada- lingula and mental foramen. The energy delivered per point was 4J che Society, the TN falls under Part III, item 13: painful cranial (133.2J/cm2), 10 sessions and 72h interval between applications. nerve injuries and other facial pain, subdivision 13.1.1, with the At the end of the photobiomodulation protocol, a new thermo- following divisions: - 13.1.1: classic TN; - 13.1.1.2: secondary graphic register was performed, showing that the pattern became TN and 13.1.1.3: idiopathic TN. symmetrical (ΔT<0.3°C). The neurologist reduced the adminis- The diagnosis is clinical, but it can be complemented by infra- tration of the drug to 150mg/day, achieving significant pain con- red thermography, useful for diagnosis and follow-up of the evo- trol. In the six-month follow-up, the patient reported effective lution of the case. Literature is still scarce regarding the use of pain control (VAS between 1 and 2) with complete recovery of thermography in TN. However, the authors are unanimous in the quality of life. affirming the promising use of this test as a diagnostic aid. Mo- reover, they stress the importance of this test in differentiating between neuropathic and pulpal pain. As a non-invasive diagnostic imaging method, thermography is capable of detecting and recording infrared images that reflect the microcirculatory dynamics of the skin surface in real time, comprising the vascular, neurovegetative and musculoskeletal systems, as well as the inflammatory processes1-3. The objective of the present study was to investigate the laser Figure 1. Thermography before treatment performance, associated with anticonvulsant on a TN patient, considering the results under a clinical and thermographic point of view.

CASE REPORT

Male patient, 62 years old. Complaints of intense short duration electric shock pain, near the nose wing, right side, grade 9 on the Figure 2. Thermography after treatment - 72 hours after the last ses- visual analog scale (VAS). As triggering factors, the patient cited sion chewing, shaving, brushing his teeth and speaking. The records stated that the pain was diagnosed 4 years ago as idiopathic TN, being treated by the neurologist with oxcarbazepine (600mg) di- DISCUSSION vided into 2 doses a day in the first two years, a dosage which was doubled in the last year. Between 2016 and 2017 the patient The effects of photobiomodulation are very well documented, in- underwent prosthetic rehabilitation with dental implants. cluding the control of neuropathic pain. A recent systematic re- The neurologist’s proposal was to increase the dose even more, view evaluating the efficacy of LIT therapy in the treatment of and this approach was not tolerated by the patient because of the neuropathic pain concluded that such treatment can be effecti- adverse effects, such as drowsiness, loss of reflexes and vertigo. ve for both TN and other conditions such as occipital neuralgia Thus, in order to improve the symptoms without increasing the and burning mouth syndrome, isolated or in combination with experienced adverse effects, the treatment was proposed using other therapies5.This same recommendation can be observed by low intensity laser (LIT). In order to facilitate the diagnosis and another study6. As for the combination of laser therapy and drug, quantify the therapeutic follow-up, an infrared thermography the controlled study7 demonstrated that the use of laser can com- examination was requested. In the first register, it was possible to plement pharmacotherapy allowing the reduction of the dose and identify the hyporradiant involvement of the second and third consequently achieving less adverse effects. Variations in protocols trigeminal nerve branches on the right side, thermal asymmetry have been observed in the literature, which may lead to erroneous of the middle thirds=0.4oC and lower thirds=0.6oC. The equi- conclusions due to underdosing, inadequate wavelength, etc.8. pment used for the image acquisition was ThermaCAM® T450 Photobiomodulation has also been investigated for other orofa- (FLIR®Systems, Inc., Wilsonville, OR), and the entire thermo- cial neuropathic pains, such as post-herpetic neuralgia9,10, diabetic graphic protocol was based on the guideline of the American neuropathic pains11,12 and non-orofacial neuropathic pains, such Academy of Thermology (AAT)4. as in the sciatic nerve13. Comparison of photobiomodulation and The photobiomodulation treatment was proposed and accepted other non-pharmacological therapies, such as transcranial electro- following the protocol below: magnetic stimulation, has shown that both can be effective, the LIT with 100mW output power, using the near infrared wavelen- former being more effective when dealing with pain associated gth, 808nm. Spot application, with a distance of 5 mm between with systemic diseases, such as multiple sclerosis14. points, along the path of the maxillary branch of the lower re- The mechanisms that can explain these positive effects are related gion of the zygomatic arch until the emergence of the infraorbital to the optimization of the mitochondrial activity, modulation of 286 Photobiomodulation as an adjuvant in the pharmacological BrJP. São Paulo, 2020 jul-sep;3(3):285-7 treatment of trigeminal neuralgia. 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Therapeutic and ticles and no standardization regarding protocols, but the litera- analgesic efficacy of laser in conjunction with pharmaceutical therapy for trigeminal ture shows that the use of this imaging technique is promising neuralgia. J Lasers Med Sci. 2018;9(1):63-8. 8. Amanat D, Ebrahimi H, Lavaee F, Alipour A. The adjunct therapeutic effect of lasers as a diagnostic aid. Thermal asymmetry is the determinant that with medication in the management of orofacial pain: double blind randomized con- will indicate possible alterations. The sympathetic reflexes that trolled trial. Photomed Laser Surg. 2013;31(10):474-9. 9. Al-Maweri SA, Kalakonda B, AlAizari NA, Al-Soneidar WA, Ashraf S, Abdulrab S, will trigger paroxysmal pain without nociceptive stimuli can be et al. Efficacy of low-level laser therapy in management of recurrent herpes labialis: a detected by temperature differences of 0.4ºC1-3. systematic review. Lasers Med Sci. 2018;33(7):1423-30. 10. Gomes RN, Viana LV, Ramos JS, Castro NM, Nicolau RA. Effects of photobiosti- In the present report, it was possible to observe that the patient’s mulation in the treatment of post-herpetic neuralgia: a case report. Rev Bras Geriatr improvement was coherent to the thermic symmetry thermogra- Gerontol. 2018;21(1):102-7. phic images between the right and left side with ΔT<0.3°C, for 11. Abdel- Wahhab KG, Daoud EM, El Gendy A, Mourad HH, Mannaa FA, Saber MM. Efficiencies of low-level laser therapy (LLLT) and gabapentin in the management of peri- the immediate post-surgery as well as the six months control, pheral neuropathy: diabetic neuropathy. Appl Biochem Biotechnol. 2018;186(1):161-73. remaining stable and effective. 12. Rocha IR, Ciena AP, Rosa AS, Martins DO, Chacur M. Photobiostimulation reverses alodynia and peripheral nerve damage in streptozotocin-induced type 1 diabetes. La- sers Med Sci. 2017;32(3):495-501. CONCLUSION 13. de Andrade ALM, Bossini PS, do Canto de Souza ALM, Sanchez AD, Parizotto NA. Effect of photobiomodulation therapy (808 nm) in the control of neuropathic pain in mice. Lasers Med Sci. 2017;32(4):865-72. The photobiomodulation associated with the first-choice an- 14. Seada YI, Nofel R, Sayed HM. Comparison between trans-cranial electromagnetic stimulation and low-level laser on modulation of trigeminal neuralgia. J Phys Ther Sci. ticonvulsant drug was effective in controlling pain caused by 2013;25(8):911-4. idiopathic TN. The registries obtained by thermography were 15. Holanda VM, Chavantes MC, Wu X, Anders JJ. The mechanistic basis for photobio- coherent to the improvement of the symptoms reported by the modulation therapy of neuropathic pain by near infrared laser light. Lasers Surg Med. 2017;49(5):516-24. patient, both in the immediate and mid-term results. The use of 16. de Andrade AL, Bossini PS, Parizotto NA. Use of low-level laser therapy to control LIT has allowed the reduction of drug dosage and, consequently, neuropathic pain: a systematic review. J Photochem Photobiol B. 2016;164:36-42. 17. Astasio-Picado A, Martínez EE, Gómez-Martín B. Comparison of thermal foot maps of adverse effects, significantly improving the quality of life of between diabetic patients with neurophatic, vascular, neurovascular, and no complica- the patient. New optimized protocols should be created, both in tions. Curr Diabetes Rev. 2019;15(6):503-9. 18. Gatt A, Falzon O, Cassar K, Ellul C, Camilleri KP, Gauci J, et al. Establishing diffe- photobiomodulation and the recording of thermographic patter- rences in thermographic patterns between the various complications in diabetic foot ns in patients with neuropathic orofacial pain and TN. disease. Int J Endocrinol. 2018;12;2018:9808295.

287 BrJP. São Paulo, 2020 jul-sep;3(3):288-91 CASE REPORT

Pain management in patients with knee osteoarthritis by ultrasound- guided genicular nerve block. Case reports Manejo de dor em pacientes com osteoartrite de joelho por bloqueio dos nervos geniculares guiado por ultrassonografia. Relato de casos

Thiago Alves Rodrigues1, Eduardo José Silva Gomes de Oliveira1, João Batista Santos Garcia1

DOI 10.5935/2595-0118.20200051

ABSTRACT RESUMO

BACKGROUND AND OBJECTIVES: Knee osteoarthritis is JUSTIFICATIVA E OBJETIVOS: A osteoartrite do joelho é a chronic disease that tends to affect elderly people and is cha- uma doença crônica que tende a afetar pessoas idosas e é carac- racterized by severe pain, joint stiffness and limited function. In terizada por dor intensa, rigidez articular e limitação da mobili- more advanced cases, the initial approach of knee osteoarthri- dade. Em casos mais avançados, a abordagem da osteoartrite do tis performed with traditional conservative pharmacological or joelho com o tratamento conservador convencional farmacoló- non-pharmacological treatment may not present satisfactory re- gico e não farmacológico pode não apresentar resultados satisfa- sults. There are alternatives for pain intervention with favorable tórios. Nesse sentido, existem alternativas de intervenção em dor results, with longer analgesia and that can help rehabilitation, com resultados favoráveis, com maior tempo de analgesia e que such as analgesic peripheral nerve blocks, including the genicular auxiliam a reabilitação, como a realização de bloqueios analgési- nerve block, and radiofrequency ablation. The objective of this cos em nervos periféricos, como bloqueio dos nervos geniculares study is to report cases of genicular nerve block guided by ultra- e a ablação por radiofrequência. Este estudo teve como objetivo sonography, with favorable results in relation to analgesia and relatar casos de bloqueios dos nervos geniculares guiados por ul- return of functional capacity. trassonografia, com resultados favoráveis em relação à analgesia e CASE REPORTS: Four elderly patients diagnosed with advan- retorno da capacidade funcional. ced knee osteoarthritis, with limited range of motion, and with RELATO DOS CASOS: Quatro pacientes idosos diagnosticados severe chronic pain (mean visual numeric scale - VNS=7.75) com osteoartrite de joelho em grau avançado, com limitação da were submitted to ultrasound-guided genicular nerve block, pre- amplitude de movimento e com dor crônica, com intensidade mé- senting significant pain improvement (mean VNS after 1 month dia de 7,75 pela escala visual numérica, foram submetidos ao blo- of block=2.25) and regain of functional capacity. There were no queio de nervos geniculares guiado por ultrassonografia, apresen- cases of complications. tando melhora importante da dor após um mês do bloqueio, com CONCLUSION: Genicular nerve block guided by ultrasono- intensidade média de 2,25 e reganho da capacidade funcional, não graphy is a technique that can be performed as an intervention havendo casos de complicações relacionadas aos bloqueios. measure in pain. It presents satisfactory results of analgesia and CONCLUSÃO: O bloqueio dos nervos geniculares guiado por regain of functional capacity, facilitating the rehabilitation pro- ultrassonografia é uma técnica que promoveu analgesia satisfató- cess, and can be adopted in an outpatient clinic context. ria e ganho da capacidade funcional, além de facilitar o processo Keywords: Knee osteoarthritis, Nerve block, Pain, Ultrasonography. de reabilitação, podendo ser realizada em caráter ambulatorial. Descritores: Bloqueio nervoso, Dor, Osteoartrite do joelho, Ultrassonografia.

INTRODUCTION Thiago Alves Rodrigues – https://orcid.org/0000-0003-3086-6844; Eduardo José Silva Gomes de-Oliveira – https://orcid.org/0000-0003-0883-4774; Knee osteoarthritis (KOA) is a chronic disease that tends to affect João Batista Santos Garcia – https://orcid.org/0000-0002-3597-6471. elderly people and is characterized by severe pain, joint stiffness 1. Universidade Federal do Maranhão, Hospital Universitário, Ambulatório de Dor Crônica, and limited function1-3. The therapeutic approach to KOA in- São Luís, MA, Brasil. cludes pharmacological and non-pharmacological techniques4,5. Submitted on February 14, 2020. Despite these treatments, however, many patients continue to Accepted for publication on May 10, 2020. suffer with refractory knee pain6. Conflict of interests: none – Sponsoring sources: none. In that regard, there are pain intervention alternatives that produ- Correspondence to: ce significant reduction of pain and aid the rehabilitation through Thiago Alves Rodrigues R. Barão de Itapari, 282 – Centro the improvement of the functional capacity, like peripheral nerve 65070-220 São Luís, MA, Brasil. block and the use of radiofrequency (RF) ablation10-12. E-mail: [email protected] The peripheral nerve blocks of the inferior limbs are techniques © Sociedade Brasileira para o Estudo da Dor already well described in the literature. The not so frequent use of 288 Pain management in patients with knee osteoarthritis by BrJP. São Paulo, 2020 jul-sep;3(3):288-91 ultrasound-guided genicular nerve block. Case reports these techniques in outpatient clinics may be due to, in some ca- advanced KOA (Kellgren-Lawrence grade ≥3). In these patients, ses, the necessity of a high volume of anesthesia, several injections, conservative treatment for pain relief was not being satisfactory. a potential secondary motor block, which limits the outpatient pa- They did not present connective tissue diseases, nor previous tient treatment, the necessity of a complete anatomical review, but, neurological deficits or psychiatric diseases (Table 1). more than anything, the lack of knowledge about the benefits that The GNB was performed in the proceedings room of the chronic peripheral nerve blocks can bring for the patient7-9. The ultrasound pain outpatient clinic under aseptic technique and blood pressu- (US) guided nerve block techniques are based on the direct view re, cardioscope and arterial oxygen saturation monitoring. No of the structures and needle, enabling the real time monitoring of sedatives or premedication were administered. Each patient was the local anesthetic, resulting in a more efficient block, with lower placed in supine position with a pillow under the popliteal fossa latency, anatomical references dependency and anesthetic solution to relieve discomfort and position the slightly flexed knees. The volume, as well as being safer13. 12MHz high frequency linear transducer was positioned for a The innervation of the knee joint is provided by several joint flat approach, first SM, then SL and finally IM, along the epi- branches, divided into anterior and posterior compartments. physis of the femur or tibia, being moved up or down to identify The nerve branches of the anterior compartment come from the the epicondyles of the referred bones. The genicular arteries were femoral, common fibular and saphenous nerves. The branches of identified near the periosteum, at the junctions of the epicondy- the posterior compartment come from the tibial, obturator and le with the epiphyses of the femur and tibia, confirmed by the sciatic nerves. The combination and organization of these ante- presence of pulsatility. Therefore, the target points of the GNB rior branches generate the genicular nerves, which are respon- should have been close to each genicular artery, because the SL, sible for most of the sensory innervation of the anterior area of SM, and IM genicular arteries run alongside their respective ge- the knee joint14-19, therefore, they are targets for sensory blocks7-9 nicular nerves, or femoral and tibial cortical surfaces, due to their and RF ablation10-12. The superomedial (SM), superolateral (SL) topographic relationship with the genicular neurovascular bun- and inferomedial (IM) genicular branches can be achieved with dles (Figures 1, 2, and 3). great accuracy under US guidance, with direct visualization or After confirming the positioning of the Pajunk® 22Gx100mm visualization of reference points that determine the location by UniPlex NanoLine needle tip near a genicular artery, 5mL of a proximity15,16. solution containing 4mL of bupivacaine without vasoconstrictor The genicular nerve block (GNB) guided by US is based on at 0.5% and 1mL (2mg) of dexamethasone at each target site anatomy studies that demonstrate that the genicular nerves are (SL, SM and IM), totaling 15mL of solution, were administered. accompanied by genicular arteries and are located close to bone, muscle and tendinous structures14-19 that allow better visualization and accuracy with US15,16. Punctures close to the location of each nerve meant to be blocked are performed around the knee, allowing the infiltration of local anesthetic and corticosteroid so- lution7-9. The present study’s objective was to report a series of cases evaluating the efficacy of the US block technique regarding time of analgesia and return of functional capacity.

CASE REPORTS

This series of reports included patients seen in the Chronic Pain Outpatient Clinic of the University Hospital of the Universidade Federal do Maranhão between October 2019 and January 2020. The presented patients were elderly (60-79 years, mean=69 Figure 1. Genicular nerve block. years) with chronic knee pain and radiological findings revealing Source: https://calvinjohnsonmd.com/geni-cular-block

Table 1. Patients diagnosed with KOA submitted to genicular block guided by US Cases Gender Age Comorbidities Function Treatment Rehabilitation Genicular VNS VNS one month (years) limitation. block before after block 1 M 79 SAH/CAD/DM2/OP 45º Glucosamine+ PST Bilateral 8 3 condroitin Analgesic 2 F 60 OA/OP 45º Glucosamine+ PST Bilateral 7 2 condroitin/duloxetine Analgesic 3 M 71 SAH/OP 45º Glucosamine+ PST Bilateral 8 1 condroitin/codeine Analgesic 4 F 66 OA/OP/SAH/DM2 45º Dipyrone/ PST Left 8 3 Glaucoma alendronate/codeine Analgesic CAD = coronary artery disease; DM2 = diabetes mellitus type 2. SAH = systemic arterial hypertension; OA = Osteoarthritis; OP = Osteoporosis; PST = physiotherapy; VNS: visual numeric scale; M = male; F = female.

289 BrJP. São Paulo, 2020 jul-sep;3(3):288-91 Rodrigues TA, Oliveira EJ and Garcia JB

such as weight reduction and exercise4,5. Although there are several modalities of conservative treatment, they may not be able to achieve good results in more advanced cases, which present higher levels of pain and function decrease, resulting in the occurrence of treatment refractory pain6. Making use of minimally invasive techniques, like peripheral blocks, may be of great benefit for the pain management of such patients. In that context, GNB is a valid therapeutic option, as reported in the present series of cases. The GNB technique under US guidance included the SM, SL and IM genicular nerves for sensory block. The lateral inferus branch is not included due to its proximity to the common fibular nerve, responsible for the motor innervation of the leg and foot16,18. Geni- cular arteries and bone surfaces were used as reference points in the US, a method already reported in other studies, to perform block by dispersion of the solution close to the nerve and providing greater Figure 2. Genicular superolateral nerve and artery safety during the procedure7,8,11. Since these nerve structures are difficult to visualize due to their small size and the arteries that follow their paths, the reference points for the GNB should be close to each genicular artery or to the cortical surface of the bone, regardless of the visualization of the respective nerves, since they are easier to locate under US guidance due to the pulsatility of the arteries and hyperechogenicity of the bones7,8,11. However, in elderly and advanced peripheral vascular disease patients, these arteries may not be visible or may have very small diameters, which is an obstacle for visualization. Thus, other important reference points are the femoral and tibial cortical surfaces, due to their close topographic relation with the genicular neurovascular bundles. The use of US makes it easier to reach the genicular nerves by dis- persing larger volumes of the solution containing local anesthetic and corticosteroids, using these structures as reference, in case of imprecise location15,16. The chosen dosage was based on previously published data, which present a variation in relation to the solution volume, varying from 2 to 6mL, according to the local anesthetics and corticosteroids utilized, as well as their concentration7-9,20. It Figure 3. Genicular superolateral nerve block using the relation bet- is worth noting that GNB can also be performed with radiosco- ween artery and nerve to guide the positioning of the needle py, which requires a larger structure and a surgical setting, and does not allow the visualization of vascular structures without the use of contrast16,18. GNB associated with corticosteroids may present effi- In cases of bilateral block, these were performed with one-week cacy similar to the RF ablation9, an emergent technique, generally interval for each knee. preceded by a diagnosis GNB with local anesthetic, which seems The patients were monitored for 2 hours in the recovery room to be effective in the treatment of pain that is hard to control in ca- and then released. During these 2 hours, the patients were ses of KOA10-12. Thus, GNB associated with corticosteroids was the evaluated in relation to the range of motion and ability to walk choice for this study due to the benefit in the management of these without the help of orthotics. Pain was assessed using VNS be- kinds of pain, momentarily improving the pain scenario, enabling fore the block and after 1 month of the procedure. The mean more adherence to the rehabilitation adjuvant therapies for patients VNS before the procedure was 7.75 and, after 1 month, 2.25. All with KOA, as well as presenting the possibility of a continuous im- patients presented significant improvement of pain and range of provement over time. Using US to guide the procedure enhances motion, achieving rehabilitation more easily. No complications safety, avoiding complications related to the vascular puncutre19,21 or in relation to the technique were observed. mishaps when performing the block and allowing the procedure to be done in an outpatient setting without further difficulties. DISCUSSION GNB can be an intervention that facilitates the rehabilitation process, and more studies are needed so that more concrete and The conservative treatment approach of the KOA encompasses, precise indications are established. Its action on the sensitive in- beyond pharmacological therapy, the prescription of physiothe- nervation of the knee is an option to be considered when joint rapy, hydrotherapy, acupuncture, viscosupplementation, intra-ar- infiltration and total knee prosthesis cannot be performed, or ticular corticosteroid infiltrations, orthotics and lifestyle changes, when there is associated comorbidity that contraindicates infil- 290 Pain management in patients with knee osteoarthritis by BrJP. São Paulo, 2020 jul-sep;3(3):288-91 ultrasound-guided genicular nerve block. Case reports tration due to the risk of hematoma or septic arthritis. It may 8. Demir Y, Güzelküçük U, Tezel K, Aydemir K, Taşkaynatan MA. A different approach to the management of osteoarthritis in the knee: Ultrasound guided genicular nerve also be an option when joint infiltration is no longer effective block. Pain Med. 2017;18(1):181-3. or in cases where the patient is waiting for a knee arthroplasty. 9. Qudsi-Sinclair S, Borrás-Rubio E, Abellan-Guillén JF, Padilla Del Rey ML, Ruiz-Me- rino G. A comparison of genicular nerve treatment using either radiofrequency or analgesic block with corticosteroid for pain after a total knee arthroplasty: a double- CONCLUSION -blind, randomized clinical study. Pain Pract. 2017;17(5):578-88. 10. Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized con- In these case reports, GNB reveals itself as an effective treatment trolled trial. Pain. 2011;152(3):481-7. for chronic pain related to KOA, in which US facilitated and 11. Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. improved results, also being useful in cases of imprecise location 2014;6(4):373-6. caused by vascular involvement resulting from the use of larger 12. Kesikburun S, Yaşar E, Uran A, Adigüzel E, Yilmaz B. Ultrasound-guided genicular nerve pulsed radiofrequency treatment for painful knee osteoarthritis: a preliminary volumes of anesthetic solution. report. Pain Physician. 2016;19(5):E751-9. 13. Helayel PE, Conceição DB, Oliveira Filho GR. Bloqueios nervosos guiados por ultra- REFERENCES -som. Rev Bras Anestesiol 2007;57(1):106-23. 14. Hirasawa Y, Okajima S, Ohta M, Tokioka T. Nerve distribution to the human knee joint: anatomical and immunohistochemical study. Int Orthop. 2000;24(1):1-4. 1. Neogi T, Zhang Y. Epidemiology of osteoarthritis. Rheum Dis Clin North Am. 15. Yasar E, Kesikburun S, Kiliç C, Güzelküçük Ü, Yazar F, Tan AK. Accuracy of ultrasou- 2013;39(1):1-19. nd-guided genicular nerve block: a cadaveric study. Pain Physician. 2015;18(5):E899- 2. Nazarinasab M, Motamedfar A, Moqadam AE. Investigating mental health in pa- 904. tients with osteoarthritis and its relationship with some clinical and demographic fac- 16. Tran J, Peng PWH, Lam K, Baig E, Agur AMR, Gofeld M. Anatomical Study of the tors. Reumatologia. 2017;55(4):183-8. Innervation of Anterior Knee Joint Capsule: Implication for Image-Guided Interven- 3. de Rooij M, van der Leeden M, Heymans MW, Holla JF, Häkkinen A, Lems WF, et tion. Reg Anesth Pain Med. 2018;43(4):407-14. al. Prognosis of pain and physical functioning in patients with knee osteoarthritis: a 17. Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of systematic review and meta-analysis. Arthritis Care Res. 2016;68(4):481-92. the anterior capsule of the human knee: implications for radiofrequency ablation. Reg 4. Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Anesth Pain Med. 2015;40(4):363-71. et al. OARSI Guidelines for the non-surgical management of knee, hip, and polyarti- 18. Fonkoué L, Behets C, Kouassi JK, et al. Distribution of sensory nerves supplying the cular osteoarthritis. Osteoarthritis Cartilage. 2019;27(11):1578-89. knee joint capsule and implications for genicular blockade and radiofrequency abla- 5. DeRogatis M, Anis HK, Sodhi N, Ehiorobo JO, Chughtai M, Bhave A, et al. Non- tion: an anatomical study. Surg Radiol Anat. 2019;41(12):1461-71. -operative treatment options for knee osteoarthritis. Ann Transl Med. 2019;7(Suppl 19. Kim SY, Le PU, Kosharskyy B, Kaye AD, Shaparin N, Downie SA. Is genicular nerve 7):S245. radiofrequency ablation safe? A literature review and anatomical study. Pain Physician. 6. Crawford DC, Miller LE, Block JE. Conservative management of symptomatic knee 2016;19(5):E697-705. osteoarthritis: a flawed strategy? Orthop Rev. 2013;5:e2. 20. Ergönenç T and Serbülent GB. Long-term effects of ultrasound-guided genicular ner- 7. Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, et al. Ultrasound-guided ve pulsed radiofrequency on pain and knee functions in patients with gonarthrosis. genicular nerve block for knee osteoarthritis: a double-blind, randomized controlled Sakarya Med J. 2019;9(1): 52-8. trial of local anesthetic alone or in combination with corticosteroid. Pain Physician. 21. Strand N, Jorge P, Freeman J, D’Souza RS. A rare complication of knee hematoma 2018;21(1):41-52. after genicular nerve radiofrequency ablation. Pain Rep. 2019;4(3):e736.

291 BrJP. São Paulo, 2020 jul-sep;3(3):292-3 LETTER TO THE EDITOR

What about patients with pain during and after the COVID-19 pandemic? O que falar sobre pacientes com dor durante e após a pandemia por COVID-19?

DOI 10.5935/2595-0118.20200181

Dear editor, Additionally, telehealth is probably going to be incorporated by some services after this forced usage of technological tools What a start to this 2020! The pandemic situation has brought and experience with patients, as it was considered in the re- uncountable challenges for public health, politics, economy, cent PAIN publication this month7. However, health profes- and interpersonal relationships around the world. COVID-19 sionals must be careful later when this humanitarian crisis has made huge impacts1 A focus has been driven to the care for is solved once we will need to have clear criteria to indicate patients who were infected by the virus, particularly those who what kind of patient/disease/dysfunction or what phase of developed severe respiratory dysfunction. On the other hand, pain management can be addressed using telehealth. There is many patients with chronic diseases have been devoid of routine, no guarantee this is going to work widely in any case. Chronic safe and easy access to health care. pain is multidimensional, and patients in pain usually require Pain is the most prevalent health complaint all over the world, personal contact and assistance. In a recently letter published and unrelieved pain remains a global health problem. However, in BrJP8 described the main factors that must be considered a systematic review showed that the prevalence of patients with for this implementation in Brazil. chronic pain in the general population of developing countries Moreover, all individuals have biopsychosocial characteristics was 18%, Brazilian-based population studies identified a propor- that affect pain. Besides, biological components, psychoemotio- tion of 28 to 40% of the population suffering from chronic pain, nal and social aspects are relevant to the patient with pain9. Still with a higher prevalence of women, elderly and lower human considering the biological context, social isolation has highly in- development index2,3. During the global pandemic situation, terfered with the physical-based strategies for pain management. risks for pain morbidity and even mortality can be largely am- Exercise has been a gold standard to treat the most chronic pain- plified. According to the World Health Organization, previous ful conditions. pandemics led to a higher number of patients with diagnoses of However, many patients with pain need adequate professional chronic musculoskeletal pain associated with a post-traumatic supervision and appropriate space to adhere to and carry out the stress disorder4. exercise program. Now, patients are at home. Are they moving What does happen to those patients during the quarantine pe- enough? Do they have enough desire to move? Do they have riod? This scenario is not promising to patients with chronic access to health professionals to virtually help and follow them? pain, especially in developing countries. There is no doubt that Do they have access to this new technology? Are they motivated what could be done to manage pain is distinct from what has (by themselves or by family/friends) to do this? Unfortunately, been done to it in developing countries. Some factors have con- most of them have indeed stopped moving. tributed to this situation such as limited education of health pro- Furthermore, several psychoemotional aspects strongly correlate fessionals, lack of facilities for pain management and poor access with many states of pain, such as anxiety, depression, catastro- to treatments for pain relief. In developing countries, excitement phizing, fear, low self-efficacy, hypervigilance. Conditions about for pain education and exceptional clinical training has increa- humor, energy for activities, appetite, and sleep also interfere sed, whereas several barriers to practice changes in developing with emotions. All those factors contribute to initiate, maintain countries have been imposed by governments and health admi- and/or exacerbate pain conditions. nistrations5. Lastly, socio-economic status, culture, relationships can influen- Firstly patients who were being assisted had their health care dis- ce health. Many social aspects can affect and increase pain such rupted. Although telemedicine/telerehabilitation have been used as bad home conditions, lack of food and hygienic supplies, in many cases with success for many outcomes6, this cannot be worries about job, accumulation of debts, concern with family/ faced as normal life overnight. Additionally, we should highlight friends, lack of privacy, absence of family/friend support, uncer- that the situation in developing countries such as Brazil is very tainty about the future. precarious if we take into account the scarcity of appropriate Definitively, we are going to be different from before. So will our equipment and connectivity and the acculturation for this more patients. They will be transformed. Their pain characteristics will recent technological practice in the health scope. probably be changed. Are we going to have different patients with pain after the pandemic? Who were they before the pandemic? How was their pain? What did each one go through during the quarantine? How did they do it? Are you mentally prepared © Sociedade Brasileira para o Estudo da Dor enough to consider all this possible transformation? 292 What about patients with pain during and BrJP. São Paulo, 2020 jul-sep;3(3):292-3 after the COVID-19 pandemic?

Despite the pessimism put hitherto and considering science is REFERENCES changeable, is more pain the only clinical context we may expect? Maybe, serious situations of social misery, uncontrolled panic 1. Tay MZ, Poh CM, Rénia L, MacAry PA, Ng LFP. The trinity of COVID-19: immu- nity, inflammation, and intervention. Nat Rev Immunol. 2020;20(6):363-74. about the disease or the survival, increase of domestic violence, 2. Souza JB, Grossmann E, Perissinotti DMN, Oliveira Junior JO, Fonseca PRB, Posso grave daily sensation of home as prison can play a role of brain IP. prevalence of chronic pain, treatments, perception, and interference on life activities: Brazilian population-based survey. Pain Res Manag. 2017;2017:4643830. distractor and change pain manifestations as we do not know yet 3. Ferreira KASL, Bastos TRPD, Andrade DC, Silva AM, Appolinario JC, Teixeira MJ, how those extreme experiences can modulate pain status. et al. Prevalence of chronic pain in a metropolitan area of a developing country: a population-based study. Arq. Neuropsiquiatr. 2016;74(12):990-8. Attention is needed. Both health professionals and researchers 4. World Health Organization et al. Integrating palliative care and symptom relief into who conduct observational studies or clinical trials must be cons- responses to humanitarian and crises: a WHO guide. 2018. cious of many of those factors that could have affected the pain 5. Bond M. Pain education issues in developing countries and responses to them by the International Association for the Study of Pain. Pain Res Manage 2011;16(6):404-6. status of patients after the pandemic period is over, and life tends 6. Adamse C, Dekker-Van Weering MG, van Etten-Jamaludin FS, Stuiver MM. The to the new normality. effectiveness of exercise-based telemedicine on pain, physical activity, and quality of life in the treatment of chronic pain: a systematic review. J Telemed Telecare. Frequently, negative events are followed by a kind of positive 2018;24(8):511-26. transformation. We know we are already witnessing behavior 7. Eccleston C, Blyth FM, Dear BF, Fisher EA, Keefe FJ, Lynch ME, et al. Managing patients with chronic pain during the COVID-19 outbreak: considerations for the changes in some persons who have learned the value of small rapid introduction of remotely supported (eHealth) pain management services. Pain. things, and the importance of people, outdoor living, socializa- 2020;161(5):889-93. tion, daily routine, and stability. 8. Fioratti I, Reis Felipe JJ, Fernandes LG, Saragiotto BT. The COVID-19 pandemic and the regulations of remote attendance in Brazil: new opportunities for people dealing Indeed, what a restart! with chronic pain. BrJP. 2020;3(2):193-94. 9. Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977;196(4286):129-36. Josimari Melo DeSantana Universidade Federal de Sergipe, Departamento de Fisioterapia, Aracaju, SE, Brasil. http://orcid.org/0000-0003-1432-0737. E-mail: [email protected]

293 BrJP. São Paulo, 2020 jul-sep;3(3):294 LETTER TO THE EDITOR

Considerations about the new concept of pain Considerações sobre o novo conceito de dor

DOI 10.5935/2595-0118.20200190

Dear Mr. editor, ted in one single phrase, benefiting researchers and clinicians through the determination of the concept to be investigated. The definition of pain adopted by the International Association Although accepted by the majority, several clinicians and some for the Study of Pain (IASP), widely disseminated worldwide for patients manifested their discontent about the update, specially the past 41 years, defined pain as ‘’an unpleasant sensory and in the social medias. We consider it important to emphasize that emotional experience associated with actual or potential tissue the definition of pain proposed by the IASP doesn’t have the damage, or described in terms of such damage”. When this de- ambition to establish diagnosis, conduct a treatment plan or pre- finition was created, it was sufficient for conceptualizing pain as dict a prognosis for patients with pain. The notes that follow it was understood then. However, the last decades saw an inten- the updated pain formulation emphasize the variability of the se technological development that also brought a better com- clinical manifestation of pain, as well as the various components prehension of the physiopathological conditions and mechanis- that determine pain, showing respect for the subjectivity of each ms involved in nociception. There was also an increase in the patient that suffers from it. We recognize and applaud the effort humanization of medicine as a whole. Human beings started to of the task force and the methodological rigor described in the be recognized with the empathy and complexity that they deser- article that published the new concept, which elegantly updates ve and the concept of total pain, along with its multidisciplinary the understanding that the scientific community currently has aspects, gained more ground in the medical community. about this dynamic phenomenon, pain! Nowadays it’s known that pain is not always related to a tissue injury evident in histopathological terms, and that the Juliana Barcellos de Souza emotional state of the patient directly influences their per- Educa a Dor: Clínica de Tratamento ception of the pain. Thus, patients with chronic pain or other Multidisciplinar, Florianópolis, SC, Brasil  problems that affect psychological stability may report more https://orcid.org/0000-0003-4657-052X severe pain. In that sense, the medical community started E-mail: [email protected] Carlos Marcelo de Barros to accept more and more that the perception of pain is extre- Universidade Federal de Alfenas, Diretor Clínico mely individual and highly influenced by external factors. da Santa Casa de Alfenas, Fundador e Diretor Therefore, the IASP has developed a new concept, capable of Técnico da Clínica Plenus, Alfenas, MG, Brasil. embracing everything that has been achieved in terms of tech- https://orcid.org/0000-0002-1207-2867 nological and clinical advances, for the definition of pain. There- E-mail: [email protected] by, pain is now conceptualized as ‘’an unpleasant sensory and emotional experience associated with, or resembling that as- REFERENCES sociated with, actual or potential tissue damage’’. This update in the concept of pain, publish by the IASP task 1. Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, et al. The revised In- force in July, 20201, and translated into Portuguese by the Socie- ternational Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020;23. doi: 10.1097/j.pain.0000000000001939. Online dade Brasileira para o Estudo da Dor (SBED - Brazilian Society ahead of print. for the Study of Pain)2,3, highlights the presence of pain even in 2. https://sbed.org.br/wp-content/uploads/2020/08/Defini%C3%A7%C3%A3o-revisada-de-dor_3.pdf the absence of injury, by the means of an objective and concise 3. Jornal Dor (Publicação da Sociedade Brasileira para o Estudo da Dor – Ano XVIII – formulation validated to several languages and cultures, integra- 2º Trimestre de 2020 – edição 74, 11-8p.

294 INSTRUCTIONS TO AUTHORS

The Brazilian Journal of Pain (BrJP), printed version: ISSN 2595-0118 and elec- FORMATS OF WORK PRESENTATION tronic version: ISSN 2595-3192, and the Sociedade Brasileira para o Estudo da Title: Should be short, clear and concise, facilitating its classification. Must Dor (SBED - Brazilian Society for the Study of Pain) multidisciplinary medi- be sent in Portuguese and English. When necessary, a subtitle can be used. cal magazine is publication that focuses on the study of pain in the contexts of Author(s): The full name(s) of the author(s) and affiliations (in the hierar- clinics and research. The BrJP is directed towards all health professionals, in- chical order of: University, Faculty, Hospital, Department; mini curriculums cluding biologists, biomedical professionals, dentists, physical educators, nurses, are not accepted). Correspondence author: Name, conventional address, zip pharmacists, pharmacologists, physiologists, physiotherapists, doctors, veterinary code, city, state, country, and e-mail address. The authors must inform the doctors, nutritionists, psychologists, occupational therapists, etc., and all profes- ORCID of all collaborators. 1. Structured abstract, with a maximum of 250 sionals in any area of knowledge interested in the study and treatment of pain, words. Research and Clinical Trials articles must include: BACKGROUND members or not of the Sociedade Brasileira para o Estudo da Dor (SBED). The AND OBJECTIVES, METHODS, RESULTS and CONCLUSION. Case articles are the sole responsibility of the authors. The authors are fully responsible reports must include: BACKGROUND AND OBJECTIVES, CASE RE- for the articles. The periodicity is quarterly and since May 2020 the articles have PORT and CONCLUSION. Review articles must include: BACKGROU- also been published in the modality of advanced publication or Ahead of Print ND AND OBJECTIVES, CONTENT and CONCLUSION. Up to six des- (AOP). All papers submitted are peer-reviewed and the journal complies with criptors may be included. The use of DeCS - Descritores em Ciência da Saúde the Uniform Requirements of Manuscripts Submitted to Biomedical Journals da Bireme (Bireme Health Science Descriptors) is recommended, available at (URM - The International Committee of Medical Journal Editors - ICMJE). http://decs.bvs.br. 2. Abstract: The English version of the abstract should be Articles received are sent to 3-4 reviewers, who are asked to inform whether or submitted within the article. Up to six keywords may be included. 3. Body not they accept the review within 3 days. After accepting to review the article text: The text should be organized according to the type of article. Origi- the evaluation must be returned in up to 15 days. The articles that require ad- nal articles with humans or animals must have the approval of the Ethics justments are returned to the authors. After the authors response, the articles are Committee, and the process number, date of approval and the name of the reevaluated by the same reviewers who did the first evaluation or by reviewers Ethics Committee of the institution that approved the research project must chosen by the Editor. Articles with no response from the authors after six months be informed. For all articles that include information on patients or clinical are rejected but may be resubmitted. There will be as many reviews as necessary, photographs, written and signed consent must be obtained from each patient being the final approval decision made by the Editor. 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The body text structure should contain: Manuscripts submitted to the BrJP are subject to evaluation through tools in Introduction - This session should briefly describe the scope and previous order to detect plagiarism, duplication or fraud, and whenever these situations evidence-based knowledge for the research design, based on bibliographic re- are identified, the Editor will contact the authors and their institutions. If such ferences related to the topic. Should clearly describe, at the end, the objective situations are detected, authors should be prepared for an immediate refusal of of the research. Methods - Should include the study drawing, sample selection the manuscript. If the Editor is not aware of this situation prior to publication, procedures, ethical aspects, exclusion and inclusion criteria, clear description of the following issue will bring a disclaimer. 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Figures and not under evaluation by another journal and has not been previously published. tables should be sent together with the main text of the article or attached, in a This letter should also confirm that the article, if accepted, will be entitled to format that allows editing. exclusive publication in the BrJP, and that it respects ethical aspects, in the case of studies involving animals or humans. The articles may be sent in Portuguese or 2. CASE REPORTS English. The printed publication will be in Portuguese and the electronic publi- Up to three authors may be included. Case reports that are relevant and ori- cation in Portuguese and English. Its the authors responsibility to declare conflict ginal are welcome for submission in the BrJP. They must respect a limit of of interests in the manuscript itself, as well as to acknowledge financial support 1.800 words. The structure of the body text should contain: Introduction - when appropriate. The BrJP considers the duplicate or fragmented publication This session should briefly describe the previous knowledge based on evidence of the same research an ethical infraction and is careful in using mechanisms to for the clinical case, based on bibliographic references related to the subject. find text similarities and detect plagiarism. Case Report - This session should objectively describe the clinical case and the relevant details. Discussion - This section should discuss the relevant data FINAL PROOFREADING AND APPROVAL FOR PUBLICATION of the clinical case in the light of previous knowledge published in scientific When accepted, the articles will be forwarded for editorial processing, which sources, duly cited. Should conclude with the relevant aspects of the case and should take place within 7 days, and then submitted to the corresponding author information on the importance and relevance. 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© Sociedade Brasileira para o Estudo da Dor 3. REVIEW ARTICLES in paediatric pain. In: McGrath P, Stevens B, Walker S, Zempsky W. Paediatric Up to six authors may be included. Meta-analyses, systematic and integrative re- Pain. Oxford, 1st ed. New York: Oxford University Press; 2018. 85-94p. Theses views of the literature on relevant issues related to the study and therapy of pain, and dissertations: not accepted. with critical analysis of the literature, are welcome. Should be structured as follows: Introduction - This session should briefly describe the scope for the design of ILLUSTRATIONS AND TABLES the review. Content - This session should critically analyze the literature, with the All illustrations, including figures, tables and photographs must be cited in the objective of surveying, gathering and critically evaluating the research methodology text, in the preferred place of their entry. Must be listed in Arabic numerals. All and synthesizing the results of various primary studies, seeking to answer a clearly must contain a title and legend. Photos and figures should be black and white, formulated research question, using systematic and explicit methods to retrieve, restricted to a maximum of three. The same result should not be expressed by select and evaluate the results of relevant studies. Conclusion - This section should more than one illustration. Graphic signs used in tables, figures or acronyms bring the completion of the review. Acknowledgments - Acknowledgments to col- should have their correlation mentioned in the footnote. Figures and tables laborators, among others, may be cited in this section before the references. Refe- should be sent in a format that allows editing, recommended as follows: Digital rences - Must be formatted according to Vancouver standards (http://www.icmje. format. The submission letter, the manuscript and the Assignment of Rights org). Figures and tables may be included and should be sent together with the main should be forwarded as attachments. The tables should be forwarded in DOC text of the article or attached, in a format that allows editing. (Word) format and be present in the text at their place of insertion. The pictures and photos can be sent as attachments. Photos should be scanned with a mini- 4. LETTERS mum resolution of 300 DPI, in JPEG format. The file name should express the Letters or comments to any article published in the magazine may be sent, with type and numbering of the illustration (for example - Figure 1, Table 2). Copies a maximum of 400 words and up to five references, formatted according to the or reproductions of other publications shall be permitted only with the express Vancouver standards (http://www.icmje.org). authorization of the Publisher or the Author of the original article.

REFERENCES ETHICAL ASPECTS The BrJP adopts the “Vancouver Standards” (http://www.icmje.org) as the style In the case of human studies, the authors must indicate whether the study pro- for formatting references. These should be presented in the text in sequential cedures are in accordance with the ethical standards defined by the institutional numerical order, superscribed. Unpublished papers should not be cited and pre- or national Committee responsible for human studies, if applicable, and in ac- ferably abstracts presented at scientific events should be not be cited. References cordance with the Helsinki Declaration of 1975, revised in 2000. In the case of older than five years should be cited if they are fundamental to the article. Arti- animal studies, the authors should indicate whether institutional and/or national cles already accepted for publication may be cited, informing that they are in the guidelines for the care and use of laboratory animals were followed. For any process of publication. Up to six authors may be cited and, if there are more, ‘’et research, clinical or experimental, in humans or animals, this information should al’’ after the names should be included. The title of the journal should have its be included in the Methods section. The approval number and year of the Re- abbreviated name. The year, volume, issue and start and end pages should be in- search Ethics Committee should be cited. Clinical Trial Registration: The BrJP formed. Coincident numbers should not be repeated, e.g. BrJP. 2019;5(3):251-5. respects the policies of the World Health Organization and the International Committee of Medical Journal Editors (ICMJE) for the registration of clinical REFERENCES EXAMPLES trials, recognizing the importance of these initiatives for the international disse- Journal articles: mination of information on clinical research with open access. Therefore, since 1 author - Craig KD. The social communication model of pain. Can Psychol. 2012, articles or studies previously registered in a Clinical Trial Registry Platform 2009;50(1):22-32.- 2 authors - Araujo LC, Romero B. Pain: evaluation of the that meet the requirements of the World Health Organization and the Interna- fifth vital sign. A theoretical reflection. Rev Dor. 2015;16(4):291-6. - 3 authors tional Commission of Medical Journal Editors have preference for publication. - Hampton AJD, Hadjistavropoulos T, Gagnon MM. Contextual influences in The International Clinical Trials Registry Platform (ICTRP) list can be found decoding pain expressions: effects of patient age, informational priming, and on the ICTRP website. Among them is the Brazilian Registry of Clinical Trials observer characteristics. Pain. 2018;159(11):2363-74. - More than 6 authors - (ReBEC), which is a free virtual platform for the registration of experimental Barreto RF, Gomes CZ, Silva RM, Signorelli AA, Oliveira LF, Cavellani CL, and non-experimental studies, in progress or completed, conducted on human et al. Pain and epidemiologic evaluation of patients seen by the first aid unit of beings by Brazilian and foreign researchers, which can be accessed at http://www. a teaching hospital. Rev Dor. 2012;13(3):213-9. Article with published errata: ensaiosclinicos.gov.br. Sousa AM, Cutait MM, Ashmawi HA. Evaluation of the addition of tramadol over the regression time of lidocaine induced motor blocking. Experimental stu- USE OF ABBREVIATIONS dy in rats evaluation of tramadol addition on the regression time of lidocaine ]The title and abstract should not contain abbreviations. When expressions in the induced motor block. Experimental study in rats. Rev Dor. 2013;14(2):130-3. text are extensive, from the INTRODUCTION on they need not be repeated. Errata in: Rev Dor. 2013;14(3):234. After the first mention in the text, preceded by the acronym in parentheses, it is recommended that they be replaced by the initials in capital letters, for example: Supplementary article: Walker LK. Use of extracorporeal membrane oxygenation Sociedade Brasileira para o Estudo da Dor (SBED). for preoperative stabilization of congenital diaphragmatic hernia. Criteria Care Med. 1993;2(2Suppl1):S379-80. SIGNATURES The BrJP is sent to the members of the Sociedade Brasileira para o Estudo da Dor Book: (when strictly necessary) Doyle AC, editor. Biological mysteries solved, (SBED), through payment of the annual fee, and free of charge to the Libraries, 2nd ed. London: Science Press; 1991. 477-80p. Book chapter: Riddell RP, Racine Associations, Universities, Colleges, Medical Societies, Regional SBED and Lea- NM, Craig KD, Campbell L. Psychological theories and biopsychosocial models gues of Pain registered on the SBED website. 15 0 CBDOR 15o Congresso Brasileiro de Dor De 19 a 22/05/2021 Centro de Convenções Frei Caneca São Paulo - SP Programe-se!

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