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Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial.

ABSTRACT: INTRODUCTION:Chronic low back pain (cLBP) is prevalent, especially among military veterans. Many cLBP treatment options have limited benefits and are accompanied by side effects. Major efforts to reduce opioid use and embrace nonpharmacological pain treatments have resulted. Research with community cLBP patients indicates that yoga can improve health outcomes and has few side effects. The benefits of yoga among military veterans were examined. DESIGN:Participants were randomized to either yoga or delayed yoga treatment in 2013-2015. Outcomes were assessed at baseline, 6 weeks, 12 weeks, and 6 months. Intention-to-treat analyses occurred in 2016. SETTING/PARTICIPANTS:One hundred and fifty military veterans with cLBP were recruited from a major Veterans Affairs Medical Center in California. INTERVENTION:Yoga classes (with home practice) were led by a certified instructor twice weekly for 12 weeks, and consisted primarily of physical postures, movement, and breathing techniques. MAIN OUTCOME MEASURES:The primary outcome was Roland-Morris Disability Questionnaire scores after 12 weeks. Pain intensity was identified as an important secondary outcome. RESULTS:Participant characteristics were mean age 53 years, 26% were female, 35% were unemployed or disabled, and mean back pain duration was 15 years. Improvements in Roland-Morris Disability Questionnaire scores did not differ between the two groups at 12 weeks, but yoga participants had greater reductions in Roland-Morris Disability Questionnaire scores than delayed treatment participants at 6 months -2.48 (95% CI= -4.08, -0.87). Yoga participants improved more on pain intensity at 12 weeks and at 6 months. Opioid medication use declined among all participants, but group differences were not found. CONCLUSIONS:Yoga improved health outcomes among veterans despite evidence they had fewer resources, worse health, and more challenges attending yoga sessions than community samples studied previously. The magnitude of pain intensity decline was small, but occurred in the context of reduced opioid use. The findings support wider implementation of yoga programs for veterans. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT02524158.

SUBMITTER: Groessl EJ

PROVIDER: S-EPMC6399016 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial.

Groessl Erik J EJ Liu Lin L Chang Douglas G DG Wetherell Julie L JL Bormann Jill E JE Atkinson J Hamp JH Baxi Sunita S Schmalzl Laura L

American journal of preventive medicine 20170720 5

<h4>Introduction</h4>Chronic low back pain (cLBP) is prevalent, especially among military veterans. Many cLBP treatment options have limited benefits and are accompanied by side effects. Major efforts to reduce opioid use and embrace nonpharmacological pain treatments have resulted. Research with community cLBP patients indicates that yoga can improve health outcomes and has few side effects. The benefits of yoga among military veterans were examined.<h4>Design</h4>Participants were randomized t ...[more]

PMID: 28735778

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Project description:BackgroundChronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations.Methods/designThis study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records.DiscussionThis study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities.Trial registrationClinicalTrials.gov: NCT02224183.

Project description:Importance:In response to the national opioid public health crisis, there is an urgent need to develop nonopioid solutions for effective pain management. Neurosteroids are endogenous molecules with pleotropic actions that show promise for safe and effective treatment of chronic low back pain. Objective:To determine whether adjunctive pregnenolone has therapeutic utility for the treatment of chronic low back pain in Iraq- and Afghanistan-era US military veterans. Design, Setting, and Participants:Randomized, double-blind, placebo-controlled clinical trial that enrolled for 42 months, from September 2013 to April 2017. Participants were Iraq- and Afghanistan-era veterans aged 18 to 65 years with chronic low back pain who received treatment in the Durham VA Health Care System in Durham, North Carolina, over 6 weeks. Data analysis began in 2018 and was finalized in March, 2019. Interventions:Following a 1-week placebo lead-in, participants were randomized to pregnenolone or placebo for 4 weeks. Pregnenolone and placebo were administered at fixed, escalating doses of 100 mg for 1 week, 300 mg for 1 week, and 500 mg for 2 weeks. Main Outcomes and Measures:The primary outcome measure was the change in mean pain intensity ratings from a daily pain diary (numerical rating scale, 0-10) between visit 3 (baseline) and visit 6. Secondary outcomes included pain interference scores (Brief Pain Inventory, Short Form). Preintervention and postintervention neurosteroid levels were quantified by gas chromatography with tandem mass spectrometry. Hypotheses tested were formulated prior to data collection. Results:A total of 94 participants (84 [89.4%] male; mean [SD] age, 37.5 [9.8] years; 53 [56.4%] of self-reported Caucasian race and 31 [33.0%] of self-reported African American race) were included. Forty-eight participants were randomized to pregnenolone and 52 to placebo, of whom 45 and 49, respectively, were included in baseline demographic characteristics secondary to noncompliance with medications as per protocol. Veterans randomized to pregnenolone reported significant reductions in low back pain relative to those randomized to placebo. Baseline unadjusted mean (SE) pain diary ratings were 4.83 (0.23) and 5.24 (0.22) for the placebo- and pregnenolone-treated groups, respectively (baseline unadjusted mean [SE] ratings for pain recall were 4.78 [0.24] and 5.15 [0.23], respectively). Unadjusted mean (SE) ratings following treatment (visit 6) were 4.74 (0.26) in the placebo group and 4.19 (0.30) in the pregnenolone-treated group. Unadjusted mean (SE) ratings for pain recall following treatment were 4.86 (0.27) for placebo and 4.18 (0.29) for pregnenolone. Least-square mean (LSM) analysis showed that pain scores significantly improved in the pregnenolone-treated group compared with placebo (LSM [SE] change in pain diary rating, -0.56 [0.25]; P?=?.02; LSM [SE] change in pain recall, -0.70 [0.27]; P?=?.01). Pain interference scores for work (LSM [SE] change, 0.71 [0.12]; P?=?.04) and activity (LSM [SE] change, 0.71 [0.11]; P?=?.03) were also improved in veterans randomized to pregnenolone compared with placebo. Pregnenolone was well tolerated. Conclusions and Relevance:Participants receiving pregnenolone reported a clinically meaningful reduction in low back pain and 2 pain interference domains compared with those receiving placebo. Pregnenolone may represent a novel, safe, and potentially efficacious treatment for the alleviation of chronic low back pain in Iraq- and Afghanistan-era veterans. Trial Registration:ClinicalTrials.gov Identifier: NCT01898013.

Project description:BackgroundChronic low back pain (cLBP) and chronic neck pain (cNP) are highly prevalent conditions and common reasons for disability among military personnel. Yoga and other mind-body interventions have been shown to safely decrease pain and disability in persons with cLBP and/or cNP but have not been adequately studied in active duty military personnel. The objective of this study was to examine the feasibility and acceptability of delivering 2 types of yoga (hatha and restorative) to a sample of active-duty military personnel with cLBP/cNP.MethodsMilitary personnel with cLBP and/or cNP (n = 49; 59% men) were randomized to either hatha or restorative yoga interventions. Interventions consisted of in-person yoga 1-2x weekly for 12 weeks. Feasibility and acceptability were measured by rates of recruitment, intervention attendance, attrition, adverse events, and satisfaction ratings. Health outcomes including pain and disability were measured at baseline, 12 weeks, and 6 months. Means and effect sizes are presented.ResultsRecruitment was completed ahead of projections. Over 90% of participants agreed or strongly agreed that they enjoyed participation, liked the instructor, and would like to continue yoga. Retention rates were 86% and 80% at 12 week and 6 month assessments, respectively. Intervention attendance was adequate but lower than expected. There were small to moderate reductions in back-pain related disability, pain severity and pain interference, and improvements in quality of life, grip strength, and balance. In general, effects were larger for those who attended at least 50% of intervention classes. Participants with cNP tended to have smaller outcome improvements, but conclusions remain tentative given small sample sizes.ConclusionsResults demonstrate feasibility for conducting a randomized controlled comparative effectiveness trial of yoga for cLBP and cNP among active duty military personnel. Acceptability was also established. Ongoing work will enhance the intervention for cNP and establish feasibility at another military facility in preparation for a fully-powered comparative effectiveness trial.ClinicalTrials #NCT03504085; registered April 20, 2018.

Project description:BackgroundYoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain.ObjectiveTo determine whether yoga is noninferior to PT for cLBP.Design12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927).SettingAcademic safety-net hospital and 7 affiliated community health centers.Participants320 predominantly low-income, racially diverse adults with nonspecific cLBP.InterventionParticipants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice.MeasurementsPrimary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life.ResultsOne-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups.LimitationsParticipants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up.ConclusionA manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain.Primary funding sourceNational Center for Complementary and Integrative Health of the National Institutes of Health.

Project description:ImportanceAntidepressants at low dose are commonly prescribed for the management of chronic low back pain and their use is recommended in international clinical guidelines. However, there is no evidence for their efficacy.ObjectiveTo examine the efficacy of a low-dose antidepressant compared with an active comparator in reducing pain, disability, and work absence and hindrance in individuals with chronic low back pain.Design, setting, and participantsA double-blind, randomized clinical trial with a 6-month follow-up of adults with chronic, nonspecific, low back pain who were recruited through hospital/medical clinics and advertising was carried out.InterventionLow-dose amitriptyline (25 mg/d) or an active comparator (benztropine mesylate, 1 mg/d) for 6 months.Main outcomes and measuresThe primary outcome was pain intensity measured at 3 and 6 months using the visual analog scale and Descriptor Differential Scale. Secondary outcomes included disability assessed using the Roland Morris Disability Questionnaire and work absence and hindrance assessed using the Short Form Health and Labour Questionnaire.ResultsOf the 146 randomized participants (90 [61.6%] male; mean [SD] age, 54.8 [13.7] years), 118 (81%) completed 6-month follow-up. Treatment with low-dose amitriptyline did not result in greater pain reduction than the comparator at 6 (adjusted difference, -7.81; 95% CI, -15.7 to 0.10) or 3 months (adjusted difference, -1.05; 95% CI, -7.87 to 5.78), independent of baseline pain. There was no statistically significant difference in disability between the groups at 6 months (adjusted difference, -0.98; 95% CI, -2.42 to 0.46); however, there was a statistically significant improvement in disability for the low-dose amitriptyline group at 3 months (adjusted difference, -1.62; 95% CI, -2.88 to -0.36). There were no differences between the groups in work outcomes at 6 months (adjusted difference, absence: 1.51; 95% CI, 0.43-5.38; hindrance: 0.53; 95% CI, 0.19-1.51), or 3 months (adjusted difference, absence: 0.86; 95% CI, 0.32-2.31; hindrance: 0.78; 95% CI, 0.29-2.08), or in the number of participants who withdrew owing to adverse events (9 [12%] in each group; χ2 = 0.004; P = .95).Conclusions and relevanceThis trial suggests that amitriptyline may be an effective treatment for chronic low back pain. There were no significant improvements in outcomes at 6 months, but there was a reduction in disability at 3 months, an improvement in pain intensity that was nonsignificant at 6 months, and minimal adverse events reported with a low-dose, modest sample size and active comparator. Although large-scale clinical trials that include dose escalation are needed, it may be worth considering low-dose amitriptyline if the only alternative is an opioid.Trial registrationanzctr.org.au Identifier: ACTRN12612000131853.

Dataset Information

Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial.

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Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial.

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