BMJ Open BMJ Open: first published as 10.1136/bmjopen-2012-001164 on 25 June 2012. Downloaded from ACUPUNCTURE FOR ACUTE NON-SPECIFIC LOW BACK PAIN: A PROTOCOL FOR A RANDOMISED, CONTROLLED, MULTICENTER INTERVENTION STUDY IN GENERAL PRACTICE – THE ACUBACK STUDY. For peer review only Journal: BMJ Open Manuscript ID: bmjopen-2012-001164 Article Type: Protocol Date Submitted by the Author: 21-Mar-2012 Complete List of Authors: Skonnord, Trygve; University of Oslo, Institute of Health and Society Skjeie, Holgeir; University of Oslo, Institute of Health and Society Brekke, Mette; University of Oslo, Institute of Health and Society Grotle, Margreth; Oslo University Hospital, Clinic for surgery and neurology Lund, Iréne; Karolinska Institutet, Department of Physiology and Pharmacology Fetveit, Arne; University of Oslo, Institute of Health and Society <b>Primary Subject General practice / Family practice Heading</b>: Secondary Subject Heading: Complementary medicine http://bmjopen.bmj.com/ COMPLEMENTARY MEDICINE, Back pain < ORTHOPAEDIC & TRAUMA Keywords: SURGERY, PAIN MANAGEMENT, PRIMARY CARE, Clinical trials < THERAPEUTICS, Adverse events < THERAPEUTICS on September 29, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 15 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2012-001164 on 25 June 2012. Downloaded from 1 2 3 ACUPUNCTURE FOR ACUTE NON-SPECIFIC LOW BACK 4 5 PAIN: A PROTOCOL FOR A RANDOMISED, CONTROLLED, 6 MULTICENTER INTERVENTION STUDY IN GENERAL 7 8 PRACTICE – THE ACUBACK STUDY. 9 10 Corresponding author: Trygve Skonnord, MD. Department of General Practice, Institute of 11 Health and Society, University of Oslo, Post-box 1130 Blindern N-0318 Oslo, Norway 12 E-mail: [email protected], Cell phone: +47 41323232, Fax: +47 33306899. 13 14 Authors: Trygve Skonnord,1 Holgeir Skjeie,1 Mette Brekke,1 Margreth Grotle,2 Iréne Lund,3 15 Arne Fetveit.For1 peer review only 16 17 18 Affiliation information: 1 19 Department of General Practice, Institute of Health and Society, University of Oslo, PO box 20 1130 Blindern N-0318 Oslo, Norway. 21 2FORMI, Clinic for surgery and neurology Oslo University Hospital, Ullevaal, N-0407 Oslo, 22 Norway 23 3Department of Physiology and Pharmacology, Karolinska Institutet, SE-171 77 Stockholm, 24 Sweden. 25 26 27 Running title: Acupuncture for acute non-specific low back pain. 28 29 Key words: Acupuncture Therapy, Acute Pain, Clinical Research Protocol, General Practice, 30 Low Back Pain 31 32 Word Count: 3841 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 29, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 15 BMJ Open: first published as 10.1136/bmjopen-2012-001164 on 25 June 2012. Downloaded from 1 2 3 ABSTRACT: 4 Introduction: 5 Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite 6 lacking evidence of its effectiveness for this condition. 7 8 The aim of this study is to evaluate whether a single treatment-session with acupuncture can 9 reduce time to recovery when applied in addition to standard LBP-treatment according to the 10 Norwegian national guidelines. Analyses of prognostic factors for recovery and cost- 11 effectiveness will also be carried out. 12 Methods and analysis: 13 In this randomised, controlled, multicenter study in general practice in Southern Norway, 270 14 patients will be allocated into one of two treatment-groups, using a web-based application 15 based on blockFor randomisation. peer Outcome reviewassessor will be blinded only for group allocation of the 16 patients. 17 18 The control group will receive standard treatment, while the intervention group will receive 19 standard treatment plus acupuncture treatment. There will be different GPs treating the two 20 groups, and both groups will just have one consultation. Adults who consult their GP because 21 of acute LBP will be included. Patients with nerve root affection, "red flags", pregnancy, 22 previous sick leave more than 14 days and disability pension will be excluded. The primary 23 outcome of the study is the median time to recovery (days). The secondary outcomes are rated 24 global improvement, back-specific functional status, sick leave, medication, GP visits and 25 side effects. A pilot study will be conducted. 26 Ethics and dissemination: 27 28 Participation is based on informed written consent. We will apply for an ethical approval from 29 the Regional Committee for Medical and Health Research Ethics (REC), when the study- 30 protocol is completed. Results from this study, positive or negative, will be disseminated in 31 scientific medical journals. 32 Discussion: 33 This study aims to explore whether acupuncture is a useful clinical tool for treating acute LBP http://bmjopen.bmj.com/ 34 in general practice. 35 Trial Registration: 36 ClinicalTrials.gov Identifier: NCT01439412. 37 38 39 40 41 on September 29, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 15 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2012-001164 on 25 June 2012. Downloaded from 1 2 3 4 INTRODUCTION: 5 Low back pain (LBP) is a very common disorder with consequences for the individual patient 6 as well as for the society. Up to 80% of the population experiences back pain at least once in 7 their lifetime, about 50% during the previous year. Point prevalence is 15%, and the condition 8 1 9 relapses frequently, 40% within 6 months. Back pain is the medical condition that ranks highest in terms of Norwegian socio-economic expenses.2 Most people with acute LBP 10 3 11 experience improvements in pain and disability within a month, but the median time to 4 5 12 recovery recorded in studies on back pain varies widely, from 7 days to 58 days. 13 Acute LBP is treated primarily in the primary healthcare by general practitioners (GPs), 14 physiotherapists, manual therapists and chiropractors. Recommended treatment according to 15 clinical guidelinesFor contains peer information aboutreview the condition, advice only to stay active and, if 16 possible, avoid bed rest, early and gradual mobilisation after the acute phase, pain treatment 17 with paracetamol and/or non-steroidal anti-inflammatory drugs (NSAIDs) with time- 18 2 6 19 contingent doses. 20 GPs educated and trained in acupuncture also use acupuncture for the treatment of both acute 7 21 and chronic LBP cases. There is evidence that acupuncture is effective in chronic LBP, and 2 8- 22 such treatment is therefore recommended in the "National guidelines for LBP" in Norway. 23 10 Reviews and meta-analyses conclude that the documentation of acupuncture treatment for 24 acute LBP is limited by few and poorly conducted studies, however.10 11 25 26 In 1997, He presented a Chinese study with 100 patients afflicted with LBP (5 days to 6 27 months duration) randomised to either manual acupuncture with moxibustion plus Chinese 28 12 29 herbal medicine or Chinese herbal medicine alone. A later Cochrane review concludes that 30 this trial was of low methodological quality and showed limited evidence to back the fact that 31 the combined treatment was more effective for a global measure of pain and function in the 10 32 long-term follow-up. 33 http://bmjopen.bmj.com/ 34 Araki et al have published an abstract of a trial where 40 patients with acute LBP (< 3 days) 35 were randomised into two groups where the intervention group got acupuncture treatment in 36 the acupuncture point SI3 bilaterally and then performed back exercises. The control group, 37 however, received sham acupuncture treatment with mimicked needle insertion, after which 38 they were asked to perform back exercises. Araki et al found no difference between the 39 13 40 effects of acupuncture and that of the sham acupuncture. 41 on September 29, 2021 by guest. Protected copyright. 42 One of the studies referred to in the Cochrane review is a Norwegian study conducted by 43 Kittang et al.14 They found that acupuncture was as effective as medical treatment with 44 Naproxen per os in relation to pain and stiffness, but that the “Naproxen-group” had more 45 side effects and greater recurrences in the observation period. While Kittang et al conclude 46 that acupuncture is effective, this result is based on other studies showing the efficacy of 47 NSAIDs for acute LBP.15 48 49 50 Kennedy et al published a pilot study in 2008, which demonstrated the feasibility of a 51 randomised, controlled trial regarding the penetrating needle acupuncture when compared to 52 non-penetrating sham acupuncture for the treatment of acute LBP in primary care. The study 53 did not reveal any conclusions of the effects of acupuncture.16 54 55 Sham acupuncture involves inserting penetrating or non-penetrating needles in points that are 56 not classical acupuncture points and/or are not located in the same segment. Several studies 57 conclude, however, that sham acupuncture is not a valid placebo control, and this is explained 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 15 BMJ Open: first published as 10.1136/bmjopen-2012-001164 on 25 June 2012. Downloaded from 1 2 17 18 3 by neurophysiologic effects of the sham treatment. Trials with sham acupuncture need to 4 be very comprehensive in order to demonstrate differences between the effects of real 5 acupuncture and the sham treatment.19 6 7 In 2006, Vas et al published a study protocol of a four-branch randomised controlled trial, 8 which intended to obtain further evidence on the effectiveness of acupuncture on acute LBP 9 20 10 and isolate the specific and non-specific effects of the treatment.