Aromatherapy: Does It Make “Scents” As Complementary Therapy in Pain Management?

Topics in PAIN MANAGEMENT Vol. 34, No. 1 Current Concepts and Treatment Strategies August 2018 CONTINUING EDUCATION ACTIVITY Aromatherapy: Does It Make “Scents” as Complementary Therapy in Pain Management?

Angela Starkweather, PhD, ACNP-BC, FAAN The purpose of this article is to review evidence about the effectiveness of aromatherapy as a complementary therapy in the treatment of pain. Learning Objectives/Outcomes: After participating in the CME/CNE activity, the provider should be better able to: 1. Define aromatherapy and how it may be used as a complementary therapy. 2. Differentiate the 4 potential mechanisms by which aromatherapy may influence health and well-being. 3. Analyze the evidence on the effectiveness of aromatherapy for reducing pain. Key Words: Aromatherapy, Essential oils, Odor, Pain management

romatherapy is the use of concentrated essential oils, psychiatric manifestations, and infection, and integrated into Awhich are volatile liquids extracted by steam distillation spiritual practices and cultural rituals.1 or mechanical expression from flowers, herbs, or trees, to There are many essential oils available for aromatherapy, improve health and well-being. Essential oils have been a part such as bergamot, cedarwood, Roman chamomile, geranium, of the healing practices of most ancient cultures and were ginger, jasmine, lavender, lemon, and tea tree. Each type of used to treat ailments, such as fever, cough, headaches, essential oil has a unique chemical composition that deter- mines its smell, how it is absorbed, and how it affects the

Dr. Starkweather is Professor and Director, Center for Advancement in In This Issue Managing Pain, University of Connecticut School of Nursing, 231 CE Article: Aromatherapy: Does It Make “Scents” as Glenbrook Rd, Storrs, CT 06269; E-mail: angela.starkweather@ Complementary Therapy in Pain Management? ...... 1 uconn.edu. The author, faculty, and staff in a position to control the content of this ICYMI: In Case You Missed It ...... 9 CME/CNE activity have disclosed that they and their spouses/life partners (if any) have no financial relationships with, or financial CE Quiz ...... 11 interests in, any commercial organizations pertaining to this educational activity.

CME Accreditation Lippincott Continuing Medical Education Institute, Inc., is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Lippincott Continuing Medical Education Institute, Inc., designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. To earn CME credit, you must read the CME article and complete the quiz and evaluation assessment survey on the enclosed form, answering at least 70% of the quiz questions correctly. This CME activity expires on July 31, 2020. CNE Accreditation Lippincott Professional Development is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Lippincott Professional Development will award 1.0 contact hours for this continuing nursing education activity. Instructions for earning ANCC contact hours are included on page 11 of the newsletter. This CNE activity expires on June 5, 2020.

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2 CO-EDITORS body. Essential oils can be inhaled, applied topically, or ingested. However, the most common use is for inhalation.1 Elizabeth A.M. Frost, MD Most essential oils have been approved as ingredients in food Professor of Anesthesiology Icahn School of Medicine at Mount Sinai and fragrances and are labeled by the FDA as “generally rec- New York, NY ognized as safe” (GRAS). However, aromatherapy products do not need FDA approval unless there is a claim for treatment of specific diseases.3 Angela Starkweather, PhD, ACNP-BC, CNRN, FAAN Professor of Nursing Aromatherapy can be used via inhalation, topical application University of Connecticut School of Nursing with or without massage, or in baths. As the essence oils are Storrs, CT inhaled through the nasal mucosa, the molecules diffuse to receptors on olfactory sensory neurons, which send messages to the brain, where the smell is interpreted. In the limbic sys- ASSOCIATE EDITOR tem, the emotional center of the brain, aromas that are familiar can evoke memories and emotions associated with the Anne Haddad Baltimore, MD smell. Aromatic molecules carried to the lungs can enter the bloodstream and travel to other parts of the body. However, the pharmacologic properties of inhaled essence oils have not been verified in humans and many questions remain regard- EDITORIAL BOARD ing the proposed pharmacologic effects.4 Jennifer Bolen, JD Topical application of essential oils is carried out by diluting The Legal Side of Pain, Knoxville, TN the essential oil with a carrier oil (such as sweet almond oil or olive oil). Some of the aromatic oils applied topically have 3 C. Alan Lyles, ScD, MPH, RPh antibacterial, anti-inflammatory, and analgesic effects. University of Baltimore, Baltimore, MD Allergic reactions may occur when essential oils are used and a skin patch test can be performed to test for allergies, especially in patients who have multiple chemical sensitivities, Stephen Silberstein, MD Jefferson Headache Center, Philadelphia, PA seasonal allergies, or a history of topical allergic reactions. Another approach for topical application is to start with a low dilution at 1% or less, with gradual increases of 0.5% if Steven Silverman, MD Michigan Head Pain and Neurological Institute, Ann Arbor, MI The continuing education activity in Topics in Pain Management is intended for clinical and academic physicians from the specialties of anesthesiology, neurology, psychiatry, physical and rehabilitative medicine, and neurosurgery, as well as residents in those fields Sahar Swidan, PharmD, BCPS and other practitioners interested in pain management. Pharmacy Solutions, Ann Arbor, MI Topics in Pain Management (ISSN 0882-5646) is published monthly by Wolters Kluwer Health, Inc. at 14700 Citicorp Drive, Bldg 3, Hagerstown, MD P. Sebastian Thomas, MD 21742. Customer Service: Phone (800) 638-3030, Fax (301) 223-2400, or Email Syracuse, NY [email protected]. Visit our website at lww.com. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. Priority postage paid at Hagerstown, MD, and at additional mailing offices. GST registration number: 895524239. POSTMASTER: Send address changes to Topics in Pain Management, Emily Wakefield, PsyD PO Box 1610, Hagerstown, MD 21740. Connecticut Children’s Medical Center, University of Publisher: Randi Davis Connecticut School of Medicine, Hartford, CT Subscription rates: Individual: US $339, international: $467. Institutional: US $768, international $894. In-training: US $148 with no CME, international $168. Single copies: $73. Send bulk pricing requests to Publisher. COPYING: Contents of Topics in Pain Management are protected by copyright. Reproduction, photocopying, and storage or transmission by magnetic or electronic Marjorie Winters, BS, RN means are strictly prohibited. Violation of copyright will result in legal action, including civil and/ Michigan Head Pain and Neurological Institute, Ann Arbor, MI or criminal penalties. Permission to reproduce copies must be secured in writing; at the newsletter website (www.topicsinpainmanagement.com), select the article, and click “Request Permission” under “Article Tools” or e-mail [email protected]. For commercial reprints and all quantities of 500 or more, e-mail [email protected]. For Steven Yarows, MD quantities of 500 or under, e-mail [email protected], call 1-866-903-6951, or fax 1-410-528- 4434. Chelsea Internal Medicine, Chelsea, MI PAID SUBSCRIBERS: Current issue and archives (from 1999) are now available FREE online at www.topicsinpainmanagement.com. Topics in Pain Management is independent and not affiliated with any organization, vendor Lonnie Zeltzer, MD or company. Opinions expressed do not necessarily reflect the views of the Publisher, Editor, or UCLA School of Medicine, Los Angeles, CA Editorial Board. A mention of products or services does not constitute endorsement. All com- ments are for general guidance only; professional counsel should be sought for specific situa- tions. Editorial matters should be addressed to Anne Haddad, Associate Editor, Topics in Pain Management, 204 E. Lake Avenue, Baltimore, MD, 21212; E-mail: [email protected]. Topics in Pain Management is indexed by SIIC HINARI and Google Scholar.

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there are no signs of an allergic reaction. In infants up to the memory of the odor and associations with particular stimuli age of 6 months, the recommended dilution is 1 drop of within the current status and conditions of the individual. essential oil in 20 mL of carrier solution, whereas a 0.5% There is a difference between complementary therapy and dilution should be used for older children, elderly, and expect- alternative therapy. It is important to understand this distinc- ant mothers.5 To create a 1% dilution, it is generally advised tion, and the concept of integrative care. Regardless of to use 6 drops of essential oil per ounce (29.6 mL) of carrier whether aromatherapy produces a physiologic/pharmacologic oil, whereas a 5% dilution is created with 30 drops to 1 oz of mechanism, the hedonic, psychological, and contextual/ carrier oil. A maximum concentration of 5% is generally con- associative mechanisms may facilitate pain relief when aroma- sidered safe for adults. therapy is used as a complementary therapy—that is, an inter- Although the physiologic/pharmacologic mechanisms by vention that is used along with standard medical treatment. In which essential oils may influence health and well-being contrast, alternative therapies are used instead of standard remain unresolved, other mechanisms have been suggested, medical management (Figure 2). From an ethical standpoint, including hedonic (pleasantness), psychological, and contex- aromatherapy should not be used as an alternative therapy in tual/associative pathways.6 At this time, the contribution of the treatment of pain because there is no evidence that aroma- each mechanism on health and well-being is uncertain, and therapy alone is comparable to standard medical treatment of due to the contextual factors involved, further research using pain. Integrative care uses a wide range of approaches, including standard medical care and evidence-based complementary strict methodologic approaches with both subjective and and alternative therapies, to treat the patient’s mind, body, and objective measures will be required (Figure 1). spirit.9 For example, the active constituents of lavender oil are linal- To analyze the current evidence on the effects of aromather- ool and linalyl acetate.7 Although pharmacokinetic data on apy as a complementary therapy in pain management, a these metabolites have been described in animals, inhalation review of the literature was carried out using the databases and topical application of lavender oil in humans do not reach PubMed/Medline and CINAHL with the key terms: “aroma- discernable concentration in the bloodstream to mimic these 4 therapy” and “pain management.” Only primary research effects. Therefore, it seems unlikely that animal studies are studies published in English from 2012-2018 were selected comparable to the pharmacokinetics of aromatherapy in for this review. Exclusion criteria included secondary research humans. However, hedonic qualities of the aroma can produce and case studies. Studies that only measured other symptoms, changes in mood, whereas psychological mechanisms involv- such as fatigue or mood, were excluded. Initial searches on ing expectancy about the odor qualities and its effect on PubMed/Medline and CINAHL identified 60 manuscripts 8 health can also contribute to perceived well-being. The con- using the key terms. Of these, 40 were excluded because they textual/associative mechanism refers to the individual’s were review articles, or did not measure pain. We provide, next, a description of each study and evaluation of the conclu- sions from the research findings.

Figure 2. Differences between complementary, alternative, and integra- Figure 1. Proposed mechanisms of aromatherapy. Physiologic/pharma- tive treatment. A, Complementary therapies are used along with stand- cologic, hedonic, psychological, and contextual/associative mecha- ard medical treatment. B, Alternative therapies are used instead of nisms of aromatherapy have been proposed to influence health and standard medical treatment. C, Integrative medicine uses standard med- well-being; however, the relative contribution of each has not been ical treatment along with evidence-based complementary and alterna- defined. tive therapies.

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Aromatherapy for Pain in Infants significantly lower than in the other 2 groups (P < 0.001); however, there were no differences in change in heart rate and In a quasiexperimental trial, a sample of 40 infants between blood oxygen saturation from baseline between groups. 2 and 6 weeks of age and gestational age between 38 and 42 weeks who all exhibited signs of colic was randomized to Across the studies described previously, the standard of care an aromatherapy massage intervention (n = 20) or control for treatment of colic or painful procedures in neonates group (n = 20) to evaluate the effectiveness of aromatherapy should be explained and provided to both groups (interven- massage on infantile colic.10 The mothers of infants in the tion and control), whether it is skin-to-skin contact, kangaroo treatment group received aromatherapy massage training and care, or nutritive or nonnutritive sucking. All of these methods for reducing procedural pain are recommended over no were instructed to perform the abdominal massage within 1 to 13 2 minutes of the onset of a colic attack and to continue the intervention. massage for 5 to 15 minutes. The control group did not receive intervention. Aromatherapy for Painful Procedures in Children and Adults All infants were monitored once a week by the research team for a total of 5 visits. The effect of the aromatherapy In a study to evaluate inhalation aromatherapy as a means of massage was measured by the length of time the infants cried reducing pain associated with IV catheter insertion, Bikmoradi per week. Results demonstrated that the intervention group et al14 assigned 30 preschool children to receive 5 drops of laven- had a statistically significant reduction in crying time from der essence and 30 children to a control group who each inhaled the preliminary observation for each subsequent observation 5 drops of distilled water 20 minutes before venipuncture. The over 4 weeks (all P < 0.01). Oucher scale was used to assess pain severity immediately, and The authors concluded that the use of lavender oil was effec- again at 5 and 10 minutes after catheterization. Pain severity tive in reducing the symptoms of colic. However, there are between the aromatherapy and control groups was significantly several weaknesses of the study, with the major weakness reduced in the experimental group at all time points (immedi- being the lack of an attention control group, which could have ately P = 0.002; 5 minutes P = 0.001; 10 minutes P = 0.01). included massage without an essential oil component. In a randomized clinical trial, 106 patients were randomized Because massage itself may be therapeutic for infantile colic, to receive aromatherapy with lavender essential oil (n = 53) or the study does not necessarily support aromatherapy as a placebo (n = 53) during peripheral vein cannulation.15 The mechanism of pain relief. perioperative care room nurse placed either 2 drops of 1% lav- A randomized clinical trial to evaluate the scent of lavender ender essential oil or pure water on a 5-by-5 cm impermeable on pain behavior and crying time was performed among gauze pad and asked the participant to inhale for 5 minutes 80 term neonates who were allocated to the intervention (n = while in a seated position. After peripheral cannulation in the 40) or control (n = 40) group.11 The night before venous right hand, the participants were evaluated for pain, anxiety, blood sampling, infants in the intervention group were and satisfaction. The intervention group reported significantly exposed to the scent of lavender for 8 hours by placing lower pain (P = 0.01), lower anxiety (P < 0.001), and higher 10 drops of 0.5% lavender essential oil on a sterile gauze in satisfaction (P = 0.003), compared with the control group. the incubator at 10 cm from the neonate’s head. At the time of In an open crossover study among 34 hemodialysis patients blood sampling, the infant was exposed to the lavender scent. with arteriovenous fistulae, the intensity of pain was meas- The Douleur Aigue Nouveau-ne (DAN) scale was used to ured in all the patients in 3 different conditions during inser- measure behavioral pain response. Duration of crying in sec- tion of arterial needles for hemodialysis: the topical onds from the start of crying to silence was recorded. The con- application of 100% lavender essential oil, no intervention, trol group did not receive any intervention. The DAN scores and placebo with water.16 showed a significant reduction in pain in the intervention The 3 conditions were randomized. There was a minimum group (P = 0.001) compared with the control group; however, 72-hour interval between the intervention, and each partici- there was no difference in time of crying between groups. pant had only 1 nurse who inserted the needles. For the topi- In another randomized controlled trial (RCT), 135 neonates cal application method, 3 puffs of 100% lavender essential oil with icterus were allocated to a familiar scent group (n = 45), an were sprayed on the puncture site and left for 5 minutes. The unfamiliar scent group (n = 45), and a control group (n = 45).12 same procedure was used for placebo. The intensity of pain The familiar scent group was exposed to vanillin (0.64 g was assessed after the arterial needle was inserted and before diluted in 100-mL 85% glycerol) by placing 10 drops on a ster- inserting the venous needle. The participants reported a sig- ile gauze in the incubator at 10 cm from the neonate’s head for nificantly lower pain intensity score, measured by the numeric 8 hours the night before arterial puncture. For neonates in the rating scale, with use of the lavender oil compared with no unfamiliar scent group, the familiarization was not carried out intervention or placebo (P = 0.001). but blood sampling was done in the presence of the vanillin A double-blind placebo-controlled randomized study was scent. The duration of crying in the familiar scent group was conducted to evaluate inhalation aromatherapy using

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bergamot essential oil on anxiety, nausea, and pain among 37 confidence interval −3.83 to −2.29, t = −8.00, P < 0.001), fol- pediatric participants with malignant and nonmalignant condi- lowed by the baseline value of level of pain (β = −0.69, 95% tions undergoing stem cell infusion.17 The Spielberger State- confidence interval −1.07 to −0.31, t = −3.69, P < 0.001). Trait Anxiety Inventory was used to assess anxiety, whereas This difference favored the treatment group. The limitations of the visual analog scale was used to assess nausea and pain. the study included a high dropout rate in the aromatherapy Diffusion of 4 drops of essential oil per hour with a stream massage group (10 subjects) and nonrandomized methods. of air from a fan placed by the child’s bedside was used to Premenstrual syndrome (PMS) is a set of physical and psy- deliver the intervention. The placebo control group received a chological symptoms that begin approximately 1 week before non-essential oil-based scented shampoo in its fan. The same menstruation. An RCT was used to determine the effect of amount of essential oil was used regardless of the age or aromatherapy on coping with PMS in university students.20 weight of the child. The treatment group experienced greater For the study, 77 students were recruited and randomized to anxiety (P = 0.05) and nausea (P = 0.03) 1 hour postinfu- the experimental group (n = 40) or control group (n = 37), sion. Reported pain in both groups was not significantly dif- and all participants were followed up for 3 cycles in terms of ferent at 1 hour postinfusion. The authors note that bergamot PMS symptoms. One-to-one training was provided to inter- essential oil causes a dose-related sequence of sedative and vention group participants about aromatherapy and how to stimulatory behavioral effects, which may have confounded use it. Intervention group participants were provided with 10 the study findings. mL of lavender oil and a dropper. They were instructed to Among 73 hospitalized children with well-controlled type begin aromatherapy at least 10 days before the beginning of 1 diabetes, aromatherapy was used in a room during self- their menstrual cycle and use it once a day at the same hour, monitoring of blood glucose and compared with a group that and to stop it when their periods started. did not receive aromatherapy.18 The child’s pain intensity was Aromatherapy was self-administered using 3 drops of laven- measured by visual analogue scale and change in baseline der oil in 200 mL of hot water and covering the participant’s heart rate. Aromatherapy did not alter the visual analog scale head with a towel in a sitting position and inhaling the steam. score. However, after adjustment for the patient’s age and sex, The control group continued with their normal self-care. The lower change in heart rate was associated with the aromather- Premenstrual Symptoms Scale was used to assess the primary apy (P = 0.025). The authors concluded that aromatherapy outcome. There was a significant reduction in the PMS score decreased the autonomic response to a painful stimulus by in the intervention group compared with the control group lowering the change of baseline heart rate, but it did not affect (P < 0.05), with a significant reduction in pain, anxiety, the perception of pain. depressive affect, nervousness, bloating, and depressive Although the studies evaluating aromatherapy for proce- thoughts (all P < 0.05). dural pain provide some compelling findings of decreased In addition to methodologic concerns, these studies could be pain, they also suffer from not explaining standard-of-care strengthened by controlling for analgesic use and other symp- procedures for pain relief in the control groups. Although it is toms experienced by the participants. In addition, standard possible that the institutions at which the studies were con- education for self-care and other elements of standard care ducted do not provide any preemptive procedures for pain should be explained. relief, such as thermal, mechanical, or anesthetic interven- Aromatherapy for Pain in Labor and tions for venipuncture or catheter insertion, future studies Postpartum Pain should contemplate using a best-practice control group versus standard care. An RCT to analyze the effects of aromatherapy with Rosa damascena on pain and anxiety in the first stage of labor Aromatherapy for Menstrual Pain and among 110 nulliparous women was recently conducted.21 Premenstrual Syndrome Participants received 0.08 mL of R. damascena essence in the The effect of aromatherapy massage on menstrual pain was aromatherapy group and 0.08 mL of normal saline in the con- evaluated in 55 school-age girls.19 The participants were trol group, every 30 minutes from the time of cervical dilation divided into the experimental group (n = 32) or control group to 4 cm until childbirth. Essential oil of the rose plant was (n = 23) according to their preferences. The experimental obtained by water distillation and was diluted to 2% in ses- group received a 10-minute aromatherapy massage of the ame oil. Pain was measured 3 times, once at each stage of abdomen 1 time using clary sage, marjoram, cinnamon, ginger, cervical dilation (4–5, 6–7, and 8–10 cm) via the numerical and geranium in a base of almond oil. The control group self- pain rating scale. Pain severity and anxiety in the experimen- administered acetaminophen as usual. The level of pain sever- tal group were significantly lower than in the control group at ity was assessed using a visual analogue scale at baseline and each assessment (all P < 0.05). 24 hours after the intervention. Aromatherapy massage was Aromatherapy was also evaluated among 104 laboring primi- strongly associated with reduction of pain (β = −3.07, 95% gravidae who were low risk, with single pregnancies during

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the latent and early active phase.22 The experimental group (n that the 2 groups were significantly different over time in = 52) was offered 4 options of aromas to choose: lavender, pain, fatigue, and mood. geranium rose, citrus, or jasmine. Aroma oil was diffused con- These studies provide compelling evidence on the effects of tinuously by aroma diffusers using standard concentration at aromatherapy for labor pain and anxiety. Each of the studies 4 drops of oil per 300 mL of diffused water. The aromatherapy explained standard of care and provided information neces- was started when participants were admitted for labor until the sary to evaluate the strength of the evidence. end of the first stage of labor. The control group (n = 52) received standard care. Pain severity was assessed using the Aromatherapy for Postoperative, numerical rating scale. The mean differences of pain scores Musculoskeletal, and Neuropathic Pain between latent and early active phase and baseline were signif- Among 48 posttonsillectomy patients age 6 to 12 years, an icantly lower in the aromatherapy group (P = 0.01 and P = RCT was conducted with random assignment to an inhaled 0.03, respectively). Late active phase pain scores and other lavender essential oil intervention group (n = 24) or a stand- perinatal outcomes were not significantly different. ard care control group (n = 24).25 All patients received aceta- A single-blind randomized clinical trial was conducted minophen (10–15 mg/kg/dose) by mouth every 6 hours as among 120 pregnant women who were randomized to the needed for pain relief. Pain intensity, the frequencies of daily experimental group who received 2 drops of lavender essence use of acetaminophen, and nocturnal awakening due to pain inhaled during 3 stages (4–5, 6–7, and 8–9 cm of cervical were recorded for each patient for 3 days after surgery. This dilation; n = 60) or a placebo control group (n = 60).23 Pre- study found that inhaled lavender did not have any effect on and postintervention pain scores, measured by the numeric pain intensity or frequency of nocturnal awakening, although pain scale, were obtained during each stage. The results dem- there was a statistically significant reduction in daily use of onstrated no difference in pain scores during the early stage acetaminophen in the intervention group (P < 0.05 on day 1; (4–5 cm) but a significant decrease in pain during the second P < 0.001 on days 2 and 3). and third stages in the aromatherapy group compared with the An RCT among 60 participants with a history of neck pain placebo group (P < 0.001). There was no effect on the mean was conducted to assess the efficacy of aromatic essential oils duration of the active phase of labor. on neck pain.26 The experimental group (n = 30) received a cream composed of 4 essential oils—marjoram, black pepper, lavender, and peppermint—and were instructed to apply 2 g These studies provide compelling of cream directly to the affected area daily after showering or bathing until fully absorbed. The control group (n = 30) evidence on the effects of received an unscented cream. The visual analogue scale, Neck Disability Index, pressure pain threshold, and neck-joint aromatherapy for labor pain and range evaluated with a Motion Analysis System were used to anxiety. evaluate outcomes. In both groups, pain severity decreased from baseline to posttreatment (P < 0.05). However, the experimental group had lower disability, higher pain tolerance Lavender oil was also evaluated for its effect on pain, in the left and right upper trapezius, and significant improve- fatigue, and mood during the early hours of the postpartum ment in 10 motion areas. period among mothers.24 An RCT was conducted among 56 Among community-dwelling older adults with chronic pain, participants who were randomized to the intervention group a 4-week aromatherapy program was analyzed for effects on (n = 29) or control group (n = 27). The intervention group pain, depression, anxiety, and stress.27 For this study, 82 par- received lavender oil in 3 doses during the first 24 hours after ticipants were assigned to the intervention group (n = 44) or delivery, whereas the control group received sesame oil. For control group (n = 38). The 4-week intervention consisted of the intervention, 5 drops of lavender essential oil were placed 4 center-based sessions and self-administered home-based on a cotton ball and the participant was asked to hold it about sessions. The center-based sessions were held once per week 20 cm from her nose for 10 to 15 minutes and to breathe nor- in community centers to provide knowledge on pain, pain in mally. This was repeated 6 hours after the initial intervention older persons, and aromatherapy. and at bedtime. Pain, fatigue, and distress level were meas- In the sessions, lavender and bergamot essential oils were ured using the visual analog scale and mood was assessed administered by inhalation. The self-administered home- with the Positive and Negative Affect Schedule. After the first based aromatherapy consisted of an aromatic spray with intervention and the morning assessment, the intervention diluted lavender and bergamot essential oils and lavender group reported significantly lower perineal pain (P = 0.004, hydrolats. A demonstration and a return demonstration were P < 0.001), physical pain (P < 0.001), fatigue (P = 0.02; carried out to ensure that the participants knew how to use the P < 0.001), distress (P < 0.001), and negative mood (P = spray correctly. There was a slight reduction in the pain score 0.007, P < 0.001). Repeated-measures analyses demonstrated of the intervention group and a significant reduction in

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negative emotions compared with the control group. care, whereas 4 studies showed no difference in pain severity Significant differences were found between the intervention between the experimental and control groups. Limitations of and control groups on depression, anxiety, and stress scores at the systematic review include the wide variability of interven- postintervention (P < 0.05). In addition, the intervention tions (types of essential oils, concentrations, and applications), group had a significant reduction in depression, anxiety, and operations, and anesthesia types. stress scores from baseline to postintervention (P < 0.05). A systematic review and meta-analysis of 12 studies that analyzed the effectiveness of aromatherapy for pain man- Although effects on pain intensity are not consistent, studies agement was conducted in document other outcomes (such as decreased analgesic use, 2016.31 The authors reported a significant positive effect of decreased depression, anxiety, and improved quality of life) that aromatherapy in reducing pain severity compared with are important to patients. placebo or treatment as usual controls. The meta-analysis supported that the effective- In an open-label RCT, 46 patients with neuropathic pain ness of aromatherapy is more consistent for nociceptive and associated with diabetes were randomly allocated to an inter- acute pain, especially postoperative pain and obstetrical and vention group (n = 21) or control group (n = 25).28 The gynecologic pain, compared with inflammatory or chronic intervention group received aromatherapy massage 3 times pain. per week for a period of 4 weeks, whereas the control group Conclusion received routine care. The Douleur Neuropathique 4 (DN4) questionnaire, visual analog scale, and Neuropathic Pain Aromatherapy as a complementary intervention in pain Impact on Quality of Life questionnaire were used to assess management seems to have beneficial effects on pain severity the primary outcome of pain severity and quality of life. The in some studies, and positively influences mood and quality of groups were similar in terms of duration of diabetes, HbA1c life. As the emotional aspects of pain can either facilitate or level, and treatment for neuropathy. A blended oil mixture inhibit pain severity, future studies should integrate affective was used for the aromatherapy consisting of rosemary, gera- measures to provide a more thorough evaluation of the effects nium, lavender, eucalyptus, and chamomile in a coconut car- of aromatherapy. In addition, standard care for the manage- rier oil in a 5% solution. The duration of each massage was ment of pain should be clearly described and implemented in 30 minutes, with 20 minutes for the feet and 10 minutes for the control groups. The pleasantness of the intervention and the hands. At week 4, neuropathic pain scores significantly expectations of the participant should be analyzed in future decreased in the intervention group compared with the con- studies to further decipher the mechanisms by which aroma- trol group (P = 0.0001) and quality of life increased signifi- therapy influences pain perception and management. ■ cantly (P = 0.049). The authors concluded that aromatherapy References massage is an effective intervention to improve pain and qual- 1. Smith MC, Kyle L. Holistic foundations of aromatherapy for nurs- ity of life in patients with painful diabetic neuropathy. ing. Holist Nurs Pract. 2008;22:3-9. These studies provide further evidence on the effects of aroma- 2. Edris AE. Pharmaceutical and therapeutic potentials of essential therapy on mood and quality of life. Although effects on pain oils and their volatile constituents: a review. Phytother Res. intensity are not consistent, the studies document other out- 2007;21:308-323. comes (such as decreased analgesic use, decreased depression, 3. National Cancer Institute. Aromatherapy and essential oils. https:// anxiety, and improved quality of life) that are important to www.cancer.gov/about-cancer/treatment/cam/patient/aromather apy-pdq. Accessed May 19, 2018. patients. 4. Herz R. Aromatherapy facts and fictions: a scientific analysis of Systematic Review of Aromatherapy for Pain olfactory effects on mood, physiology and behavior. Inter J Management Neurosci. 2009;119:263-290. 5. Buckle J. Clinical Aromatherapy. 3rd ed. London, England: In a meta-analysis of 3 RCTs that evaluated aromatherapy Churchill Livingstone; 2015. massage for reducing cancer pain, the authors reported no sig- 6. Johnson AJ. Cognitive facilitation following intentional odor expo- nificant effect.29 The studies included 278 participants (135 in sure. Sensors (Basel). 2011;11:5469-5488. the massage with essential oil group and 143 in the usual care 7. Woronuk G, Demissie Z, Rheault M, et al. Biosynthesis and therapeutic properties of Lavandula essential oil constituents. Planta control group). A systematic review of 9 RCTs (644 partici- Medica. 2011;77:7-15. pants) analyzed the effectiveness of aromatherapy for reducing 8. Chamine I, Oken BS. Aroma effects on physiologic and cognitive 30 postoperative pain. Of these, 5 of the studies reported a sta- function following acute stress: a mechanistic investigation. J tistically significant reduction in pain compared with usual Altern Complement Med. 2016;22:713-721.

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9. National Cancer Institute. Complementary and alternative medi- 20. Uzuncakmak T, Alkaya SA. Effect of aromatherapy on coping with cine. https://www.cancer.gov/about-cancer/treatment/cam. premenstrual syndrome: a randomized controlled trial. Accessed May 19, 2018. Complement Ther Med. 2018;36:63-67. 10. Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy mas- 21. Hamdamian S, Nazarpour S, Simbar M, et al. Effects of aroma- sage using lavender oil as a treatment for infantile colic. Int J Nurs therapy with Rosa damascene on nulliparious pain and anxiety of Pract. 2012;18:164-169. labor during first stage of labor. J Integrat Med. 2018;16:120-125. 11. Sadathosseini AS, Negarandeh R, Movahedi Z. The effect of a 22. Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy familiar scent on the behavioral and physiological pain responses for reducing pain during labor: a randomized controlled trial. Arch in neonates. Pain Manag Nurs. 2013;14:e196-e203. Gynecol Obstet. 2018;297:1145-1150. 12. Razaghi N, Sadat-Hoseini AS, Aemmi SZ, et al. The effects of lav- 23. Yazdkhasti M, Pirak A. The effect of aromatherapy with lavender ender scent on pain of blood sampling in term neonates. Int. J. essence on severity of labor pain and duration of labor in primipa- Pediatr. 2015;3:535-541. rous women. Complement Ther Clin Pract. 2016;25:81-86. 13. Shah PS, Herbozo C, Aliwalas LL, et al. Breastfeeding or breast 24. Vaziri F, Shiravani M, Sadat F, et al. Effect of lavender oil aroma in milk for procedural pain in neonates. Cochrane Database Syst Rev. the early hours of postpartum period on maternal pains, fatigue, 2012;12:CD004950. and mood: a randomized clinical trial. Int J Prev Med. 2017;8:29. 14. Bikmoradi A, Khaleghverdi M, Seddighi I, et al. Effect of inhala- 25. Soltani R, Soheilipour S, Hajhashemi V, et al. Evaluation of the tion aromatherapy with lavender essence on pain associated with effect of aromatherapy with lavender essential oil on posttonsillec- intravenous catheter insertion in preschool children: a quasi-exper- tomy pain in pediatric patients: a randomized controlled trial. Int J imental study. Complem Ther Clin Pract. 2017;28:85-91. Pediatr Otorhinolaryngol. 2013;77:1579-1581. 15. Karaman T, Karaman S, Dogru S, et al. Evaluating the efficacy of 26. Ou M, Lee Y, Li C, et al. The effectiveness of essential oils for Lavender aromatherapy on peripheral venous cannulation pain and patients with neck pain: a randomized controlled study. J Altern anxiety: a prospective, randomized study. Complement Ther Clin Complement Med. 2014;20:771-779. Pract. 2016;23:64-68. 27. Tang SK, Tse MYM. Aromatherapy: does it help relieve pain, 16. Ghods AA, Abforosh NH, Ghorbani R, et al. The effect of topical depression, anxiety and stress in community-dwelling older per- application of lavender essential oil on the intensity of pain caused sons? BioMed Res Inter. 2014;430195:1-12. by the insertion of dialysis needles in hemodialysis patients: a randomized clinical trial. Complement Ther Med. 2015;23:325-330. 28. Metin ZG, Donmez AA, Izgu N, et al. Aromatherapy massage for neuropathic pain in diabetic patients. J Nurs Scholar. 2017;49:379-388. 17. Ndao DH, Ladas EJ, Cheng B, et al. Inhalation aromatherapy in children and adolescents undergoing stem cell infusion: results of 29. Chen T, Tun T, Chen P, et al. The clinical effects of aromatherapy a placebo-controlled double-blind trial. Psychooncology. massage on reducing pain for the cancer patients: meta-analysis of 2012;21:247-254. randomized controlled trials. Evid Based Complement Alternat 18. Małachowska B, Fendler W, Pomykała A, et al. Essential oils Med. 2016;2016:9147974. reduce autonomous response to pain sensation during self-moni- 30. Dimitriou V, Mavridou P, Manataki A, et al. The use of aromather- toring of blood glucose among children with diabetes. J Pediatr apy for postoperative pain management: a systematic review of Endocrinol Metab. 2016;29:47-53. randomized controlled trials. J Perianesthesia Nurs. 2017;32: 19. Hur M, Lee MS, Seong K, et al. Aromatherapy massage on the 530-541. abdomen for alleviating menstrual pain in high school girls: a pre- 31. Lakhan SE, Sheafer H, Tepper D. The effectiveness of aromather- liminary controlled clinical study. Evid Based Complement apy in reducing pain: a systematic review and meta-analysis. Pain Alternat Med. 2012;2012:187163. Res Treat. 2016;2016:8158693.

Coming Soon: • Evidence Base on Massage for Pain Management • HIV-Related Pain Management

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ICYMI: IN CASE YOU MISSED IT

Notes from recent studies related to pain management, compiled by Elizabeth A.M. Frost, MD. Genetic Risk Factors And treated with betamethasone or dexamethasone were not significantly different from comparable patients in the lidocaine Neuropathic Pain group. The higher rates of cortisol suppression at 3 weeks in those receiving epidural corticosteroid injections, particularly Approximately 7% to 10% of the general population suffers with longer-acting insoluble corticosteroid formulations, are with neuropathic pain (NP). Evidence suggests that genetic consistent with sustained systemic absorption. (See Friedly JL, factors could partially explain susceptibility to NP and that Comstock BA, Heagerty PJ, et al. Systemic effects of epidural the estimated heritability in twins is 37%. steroid injections for spinal stenosis. Pain. 159(5):876-883.) In this study, the authors reviewed and summarized the human studies that have investigated the influence of genetic factors associated with NP. Through a literature search, the COX-2 Inhibitor in Late authors identified 29 full-text articles, pointing to 28 genes Pregnancy Increases Risk of significantly associated with NP. Involvement was mainly in neurotransmission, immune response, and metabolism. Premature Delivery Associated risk factors included genetic variants in human The authors sought to quantify the risk of prematurity asso- leucocyte antigen (HLA) genes, COMT, OPRM1, TNFA, IL6, ciated with late pregnancy exposure to nonselective nonsteroi- and GCH1. In the meta-analysis, polymorphisms in HLA- dal anti-inflammatory drugs (NSAIDs), selective DRB1*13, HLA-DRB1*04, HLA-DQB1*03, HLA-A*33, cyclooxygenase-2 (COX-2) inhibitors, and biological agents. and HLA-B*44 were associated with a significantly increased They included data from the Quebec Pregnancy Cohort to risk of developing NP, whereas HLA-A*02 conferred reduced perform a population-based cohort study, including all women risk, and neither rs1799971 in OPRM1 nor rs4680 in COMT covered by the Quebec Drug Plan who had a singleton live was significantly associated with NP. birth between January 1, 1998, and December 31, 2009. Late The findings indicate a specific contribution of genetic fac- pregnancy exposure was defined as filling at least 1 prescrip- tors to the risk of developing NP, although the authors tion for nonselective NSAIDs, selective COX-2 inhibitors, or acknowledge that further large-scale studies are indicated. biological agents in the 3 months before delivery. Prematurity There is a need for genome-wide association studies with was defined as less than 37 weeks of gestation. consistent case definition to elucidate the genetic architecture A total of 156,531 pregnancies met inclusion criteria. In the 3 of NP. (See Veluchamy A, Hébert H, Meng, et al. Systematic months before delivery, 391 pregnancies were exposed to nonse- review and meta-analysis of genetic risk factors for neuro- lective NSAIDs, 55 to COX-2 inhibitors, and 12 to biological pathic pain. Pain. 159(5):825-848.) agents. After adjustment for maternal autoimmune diseases, con- comitant medication use, and other risk factors, COX-2 inhibitor Epidural Corticosteroids use in late pregnancy was associated with a 2.46-fold increased Decrease Cortisol Levels risk of prematurity (adjusted odds ratio, 2.46; 95% confidence interval, 1.28–4.72) compared with nonuse. Only late pregnancy To determine whether epidural corticosteroid injections had exposure to celecoxib was found to increase the risk. an effect on serum cortisol levels in patients with back pain, The authors concluded that use of celecoxib during late preg- investigators randomized 400 patients, all 50 years or older nancy may increase the risk of prematurity. (See Bérard A, with central lumber spinal stenosis, to receive epidural injec- Sheehy O, Girard S, et al. Risk of preterm birth following late tions of local anesthetic with a corticosteroid or local anes- pregnancy exposure to NSAIDs or COX-2 inhibitors. Pain. thetic alone. The corticosteroid selected was at the discretion 2018;159(5):948-955. doi:10.1097/j.pain.0000000000001163.) of the practitioner. Morning serum cortisol levels were measured at baseline and 3 weeks after initial injection. Favorable Findings in Phase 3 The authors found that 32 patients (20.3%) treated with corticosteroid had cortisol reduction at 3 weeks of more than 50%, compared Naldemedine Trials for Opioid- with 10 patients (6.7%) treated with lidocaine only (P = 0.002). Induced Constipation Those treated with methylprednisolone or triamcinolone had an average 3-week cortisol reduction of 41.0% (P = 0.005) In a 52-week, randomized, double-blind, phase 3 study, and 41.6% (P < 0.001) from baseline, respectively. Patients researchers evaluated the long-term safety of naldemedine, a

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peripherally acting µ-opioid receptor antagonist, in patients anti-inflammatory drugs and cyclooxygenase-2 inhibitors with opioid-induced constipation and chronic noncancer pain. seemed to be the most effective modalities. Eligible adults were randomized 1:1 to receive once-daily oral These findings support the combined use of multiple modali- naldemedine 0.2 mg (n = 623) or placebo (n = 623). The pri- ties in perioperative analgesic protocols. (See Memtsoudis SG, mary endpoint was identification of treatment-emergent Poeran J, Zubizarreta N, et al. Association of multimodal pain adverse events (AEs). Other endpoints were opioid withdrawal management strategies with perioperative outcomes and on the Clinical Opiate Withdrawal Scale and the Subjective resource utilization: a population-based study. Anesthesiology. Opiate Withdrawal Scale, pain intensity on the Numeric Rating 2018;128(5):891-902. doi:10.1097/ALN.0000000000002132.) Scale, frequency of bowel movements, and constipation-related symptoms, and quality of life on the Patient Assessment of Constipation Symptoms and Patient Assessment of Gluteal Tendinopathy: Efficacy Constipation Quality of Life scales, respectively. of Various Modalities Treatment-emergent AEs were similar in the 2 groups, as were AEs leading to discontinuation of study (5% and 6%). Diarrhea In a 3-arm, single-blinded, randomized clinical trial, was reported more frequently with naldemedine (11.0% vs researchers from Australia compared the effects of a program 5.3%). No meaningful differences were seen between groups in of load management education plus exercise and corticoster- opioid withdrawal or pain intensity. Significant improvements in oid injection use, versus no treatment, on pain and global bowel movement frequency and overall constipation-related improvement in individuals aged 35 to 70 years with lateral symptoms and quality of life were observed with naldemedine (P hip pain and gluteal tendinopathy. ≤ 0.0001 vs placebo at all time points). The drug was generally Symptoms were present for more than 3 months and con- well tolerated for 52 weeks and did not interfere with opioid- firmed by clinical diagnosis and MRI. Excluded were patients mediated analgesia or precipitate opioid withdrawal. who had been given corticosteroid injections in the previous Naldemedine significantly increased bowel movement and gener- 12 months, were undergoing physiotherapy, had undergone ally improved the quality of life without contributing to increased total hip replacement, or had neurologic conditions. pain. (See Webster LR, Nalamachu S, Morlion B, et al. Long- The 3 arms of the study were as follows: term use of naldemedine in the treatment of opioid-induced con- 1. stipation in patients with chronic noncancer pain: a randomized, Physiotherapy-led education and exercise program of 14 = double-blind, placebo-controlled phase 3 study. Pain. sessions over 8 weeks (EDX; n 69); 2. = 2018;159(5):987-994. doi:10.1097/j.pain.0000000000001174.) One corticosteroid injection (CSI; n 66); and 3. A wait-and-see approach (WS; n = 69). Multimodal Pain Management Patients reported global rating of change in hip condition (on an 11-point scale, dichotomized to success and nonsuccess) Confers Perioperative Benefits and pain intensity in the past week (0 = no pain, 10 = worst Multimodal analgesia is increasingly used for management pain) at 8 weeks, with longer term follow-up at 52 weeks. of pain in joint arthroplasties. This study assessed how the Of the 204 participants, 189 participants completed the number and types of analgesic modes might decrease opioid 52-week follow-up. Success on the global rating of change was use, complications, and resource utilization. reported at 8 weeks by 51/66 EDX, 38/65 CSI, and 20/68 WS Using the Premier Perspective database (2006–2016), total hip participants, respectively. EDX patients had better global or knee arthroplasties (n = 512,393 and n = 1,028,069, improvement scores than CSI [19.9% (4.7%–35.0%); 5.0% respectively) were included. Analgesic modes were opioids, (2.9%–21.1%)]. At 8 weeks, reported pain on the numeric rating peripheral nerve blocks, acetaminophen, corticosteroids, gabap- scale was mean score 1.5 for EDX, 2.7 for CSI, and 3.8 for WS. entin/pregabalin, nonsteroidal anti-inflammatory drugs, cycloox- Success on the global rating of change was reported at 52 weeks ygenase-2 inhibitors, or ketamine. Groups were assessed as by 51/65 EDX, 36/63 CSI, and 31/60 WS participants. Reported “opioids only” and 1, 2, or more than 2 additional modes. pain at 52 weeks was 2.1 for EDX, 2.3 for CSI, and 3.2 for WS. The authors reported that 85.6% (n = 1,318,165) of patients The authors concluded that education plus exercise and cor- received multimodal analgesia. Additions of analgesic modes ticosteroid injection resulted in higher rates of patient- were associated with stepwise positive effects: total hip reported global improvement and lower pain intensity than no arthroplasty patients receiving more than 2 modes (compared treatment at 8 weeks. Education plus exercise was better than with “opioids only”) experienced 19% fewer respiratory corticosteroid injection use. At 52-week follow-up, education events, 26% fewer gastrointestinal complications, up to a plus exercise led to better global improvement than corticos- −18.5% decrease in opioid prescriptions, and a −12.1% teroid injection use, but no difference in pain intensity. Thus, decrease in length of stay (all P < 0.05). Similar patterns a physiotherapy-led education and exercise program of at were shown in total knee arthroplasty analyses. Nonsteroidal Continued on page 12

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Topics in Pain Management CE Quiz

To earn CME credit using the enclosed form, you must read the To earn nursing CNE credit, you must take the quiz online. Go to CME article and complete the quiz and evaluation assessment survey on www.nursingcenter.com, click on CE Connection on the toolbar at the the enclosed form, answering at least 70% of the quiz questions correctly. top, select Browse Newsletters, and select Topics in Pain Management. Select the best answer and use a blue or black pen to completely fill Log-in (upper right hand corner) to enter your username and in the corresponding box on the enclosed answer form. Please indi- password. First-time users must register. As a subscriber benefit, nurses cate any name and address changes directly on the answer form. If your can earn contact hours when taking CE activities from Topics in Pain name and address do not appear on the answer form, please print that Management for free. You must enter your subscription number information in the blank space at the top left of the page. Make a photo- preceeded by LWW, in your registration profile where there is a field copy of the completed answer form for your own files and mail the orig- for Link to my subscription. The 100% discount is applied when inal answer form in the enclosed postage-paid business reply envelope. payment is requested. Non-subscribers pay a $49.00 fee to earn ANCC Your answer form must be received by Lippincott CME Institute by contact hours for this activity. July 31, 2020. Only two entries will be considered for credit. After log-in, locate and click on the CE activity in which you are Online CME quiz instructions: Go to http://cme.lww.com and click interested. There is only one correct answer for each question. A passing on “Newsletters,” then select Topics in Pain Management. Enter your score for this test is 7 correct answers. If you fail, you have the option of username and password. First-time users must register. After log-in, fol- taking the test again. When you pass, you can print your certificate of low the instructions on the quiz site. You may print your official certificate earned contact hours and access the answer key. For questions, contact immediately. Please note: Lippincott CME Institute, Inc., will not mail Lippincott Professional Development: 1-800-787-8985. The registration certificates to online participants. Online quizzes expire on the due date. deadline for CNE credit is June 5, 2020.

1. Aromatherapy uses which one of the following sub- 6. A major weakness of the quasiexperimental trial that stances from flowers, plants, and trees? included a sample of 40 infants with colic was A. Shredded leaves A. lack of an attention control group B. Volatile liquids B. mothers taught to administer the intervention C. Green stems C. the study did not measure crying time per week D. Crushed roots D. a single postassessment visit was used to measure the 2. The most common route for use of essential oils is outcome A. injection 7. In a study of the effect of a familiar smell in 135 neo- B. sublingual nates with icterus, C. by mouth A. pain behaviors in the familiar scent group were sig- D. inhalation nificantly higher 3. Which one of the following statements regarding the B. duration of crying in the familiar scent group was sig- concentration of topical aromatherapy is true? nificantly lower A. It should always be diluted with a carrier oil. C. changes in heart rate and oxygen saturation were sig- B. Higher concentrations are less likely to cause irritation. nificantly different between groups C. The same concentration is used across all age groups. D. there were no significant differences between study D. A concentration above 10% is generally safe in adults. groups 4. A mechanism that involves the pleasantness of aroma- 8. Two studies of the use of aromatherapy for pain associ- therapy is ated with peripheral vein cannulation, and a study with A. pharmacologic arterial needle insertion, demonstrated that B. psychological A. patients in the aromatherapy group reported more pain C. hedonic than those in the placebo group D. contextual B. there were more patients who reported adverse reactions in the aromatherapy group 5. Which one of the following statements regarding alter- C. patients in the aromatherapy group reported signifi- native therapy is true? cantly less anxiety and fear A. Alternative therapies are used as an adjunct to standard D. there was a significant reduction in reported pain medical care. severity in the aromatherapy group B. Aromatherapy is considered an acceptable alternative therapy for pain treatment. C. Alternative therapies are used in place of standard medical treatment. D. Essential oils are commonly used as an alternative treatment for pain. Quiz continues on page 12

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9. Aromatherapy was associated with decreased perineal 10. A study of aromatherapy massage for patients with pain, physical pain, fatigue, distress, and negative mood painful diabetic neuropathy reported in a study of A. immediate decrease in pain at 1 week and increased A. 110 nulliparous women in the first stage of labor quality of life in the intervention group B. 120 pregnant women randomized to lavender aroma- B. significantly reduced pain at 4 weeks and increased therapy or placebo quality of life in the intervention group C. 56 participants during the early postpartum period C. reduced pain and increased quality of life in the inter- D. 104 laboring primigravidae who were low risk vention and control groups D. increased pain and decreased function and quality of life in the intervention group

Continued from page 10 known safety profile. (See Uchio Y, Enomoto H, Alev L, et al. A randomized, double-blind, placebo-controlled Phase III trial of least 14 sessions would seem to be an effective management duloxetine in Japanese patients with knee pain due to osteoarthri- approach for gluteal tendinopathy. tis. J Pain Res. 2018;11:809-821. doi:10.2147/JPR.S164128.) Trial registration: prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN1261200 1126808). (See Mellor R, Bennell K, Grimaldi A, et al. Facet Blocks May Provide Education plus exercise versus corticosteroid injection use ver- Prognostic Value Before RFA sus a wait and see approach on global outcome and pain from gluteal tendinopathy: prospective, single blinded, randomized In an attempt to determine the effectiveness of different lumbar clinical trial. BMJ. 2018;361:k1662.) facet blocks and their ability to predict radiofrequency ablation (RFA) outcomes, the authors randomized 229 participants in a 2:2:1 ratio to receive intra-articular facet injections with bupiv- Duloxetine Found Effective for acaine and corticosteroid, medial branch blocks, or saline. Knee Osteoarthritis Patients reporting a positive 1-month outcome (a 2-point or more reduction in average pain score) and score higher than 3 (positive A randomized clinical trial found evidence that duloxetine satisfaction) on a 5-point satisfaction scale were followed up to could play a role in effective treatment of knee osteoarthritis. 6 months. Those who received intra-articular or medial branch Patients were randomized to receive duloxetine 60 mg/d blocks with 50% or more relief underwent RFA. All individuals (n = 161) or placebo (n = 162) for 14 weeks in a double- in the saline group underwent ablation. blind study (ClinicalTrials.gov Identifier: NCT02248480). Outcome measures were average numeric rating scale pain The primary efficacy endpoint was mean change in Brief scores 1 month after the facet or saline blocks and 3 months Pain Inventory pain severity (BPI-Severity). Secondary end- after ablation. points included improvement in other BPI-Severity scales, No difference was detected across all groups in the average including Patient Global Impression of Improvement, Clinical numerical rating scale pain score at 1-month group. Positive Global Impressions of Severity, health-related quality of life blocks were higher in the intra-articular (54%) and medial (HRQoL) scales, range of motion of the knee joint, safety and branch (55%) groups than in the placebo group (30%). RFA tolerability, and structural changes on x-ray images. was performed on 135 patients (45, 48, and 42 patients from BPI-Severity average pain improved significantly with the intra-articular, medial branch, and saline groups, respec- duloxetine versus placebo (P < 0.0001). Secondary efficacy tively). At 3 months, the average numeric rating scale pain endpoints and most HRQoL scales showed greater improve- score was not significant across all groups. However, at ments in the duloxetine group than in the placebo group. 3 months, the proportions of positive responders in the intra- Adverse events were observed in 5% of patients and were articular, medial branch block, and placebo groups were 51%, more frequent in the duloxetine group and included somno- 56%, and 24% (P = 0.005). lence, constipation, dry mouth, nausea, malaise, and The authors concluded that, although facet blocks did not decreased appetite. No marked changes in range of motion of show evidence of being therapeutic, the higher response rates the knee joint (efficacy), x-ray images, or Kellgren-Lawrence in the treatment groups suggest facet blocks may have prog- grade (safety) were observed in either group. nostic value if performed before RFA. (See Cohen SP, Doshi The authors concluded that, compared with placebo, duloxetine TL, Constantinescu OC, et al. Effectiveness of lumbar facet reduced pain and improved function in patients with knee osteo- joint blocks and predictive value before radiofrequency dener- arthritis, without causing x-ray abnormalities or altered knee vation: the facet treatment study (FACTS), a randomized, con- joint mobility. Reduced pain was associated with improved trolled clinical trial [published online ahead of print May 30, HRQoL. Adverse events were consistent with duloxetine’s 2018]. Anesthesiology. doi:10.1097/ALN.0000000000002274.)

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