<b>BACKGROUND: </b>Yoga 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.<b>OBJECTIVE: </b>To determine whether yoga is noninferior to PT for cLBP.<b>DESIGN: </b>12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927).<b>SETTING: </b>Academic safety-net hospital and 7 affiliated community health centers.<b>Participants: </b>320 predominantly low-income, racially diverse adults with nonspecific cLBP.<b>Intervention: </b>Participants 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.<b>Measurements: </b>Primary 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.<b>RESULTS: </b>One-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.<b>Limitations: </b>Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up.<b>CONCLUSION: </b>A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain.<b>Primary Funding Source: </b>National Center for Complementary and Integrative Health of the National Institutes of Health.
BACKGROUND: Chronic computer-related neck pain is common among office workers. Studies have proposed neck strengthening exercise as a therapy to pain relieving and function improvement. The aim of this study was to compare the efficacy of different loading resistance trainings and we hypothesized that women with work-related neck pain could benefit more from progressive resistance training for pain and function recovery.
METHODS: A randomized controlled trial was conducted and subjects characterized by monotonous jobs were recruited. One hundred and nine employed women with chronic neck pain were randomly allocated into three groups, namely, progressive resistance training (PRT), fixed resistance training (FRT), and control group (CG). In PRT and FRT, four exercises for neck muscles with an elastic rubber band were performed on regular basis for 6 weeks. The therapeutic effectiveness was then evaluated at pretreatment, 2, 4, and 6 weeks during training period, and 3-month posttreatment. Assessment tools included visual analog scale (VAS), Neck Disability Index (NDI), pressure pain threshold (PPT), and maximal isometric neck strength.
RESULTS: The outcomes were significantly better in PRT and FRT than those in CG at 6-week timepoint and 3-month follow-up (p = 0.000), in terms of VAS, NDI, PPT, and neck muscle strength. Besides, there were statistically significant decreases observed in VAS scores of PRT group compared with those in FRT at 4-, 6-week timepoints, and 3-month follow-up (p < 0.05).
CONCLUSIONS: The neck resistance training was an effective method for pain relieving, mobility improving, pain threshold, and neck muscle strength enhancing in women with chronic computer-related neck pain. Thus, our study provided evidence that women with work-related neck pain might benefit more from PRT, which may have important implications for future clinical practice.
TRIAL REGISTRATION: The study was qualified and registered in the Chinese Clinical Trial Registry as ChiCTR-TRC-12002723.
<b>STUDY DESIGN: </b>Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP).<b>OBJECTIVE: </b>To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC.<b>Summary Of Background Data: </b>CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored.<b>METHODS: </b>A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization.<b>RESULTS: </b>Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR.<b>CONCLUSION: </b>In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society.<b>LEVEL OF EVIDENCE: </b>2.
Multidisciplinary treatments have shown to be effective for fibromyalgia. We report detailed functional outcomes of patients with fibromyalgia who attended a 3-month Multidisciplinary treatment program. The hypothesis was that patients would have increased functional status, physical activity level, and exercise regularity after attending this program. We performed a retrospective analysis of a randomized, simple blinded clinical trial. The inclusion criteria consisted of female sex, a diagnosis of fibromyalgia, age 18-60 and 3-8 years of schooling. Measures from the Fibromyalgia Impact Questionnaire (FIQ) and the COOP/WONCA Functional Health Assessment Charts (WONCA) were obtained before and at the end of the treatment and at 3-, 6-, and 12-month follow-ups. Patients recorded their number of steps per day with pedometers. They performed the six-minute walk test (6 MW) before and after treatment. In total, 155 women participated in the study. Their median (interquartile interval) FIQ score was 68.0 (53.0-77.0) at the beginning of the treatment, and the difference between the Multidisciplinary and Control groups was statistically and clinically significant in all of the measures (except the 6-month follow-up). The WONCA charts showed significant clinical improvements in the Multidisciplinary group, with physical fitness in the normal range across almost all values. In that group, steps/day showed more regularity, and the 6 MW results showed improvement of -33.00 (-59.8 to -8.25) m, and the differences from the Control group were statistically significant. The patients who underwent the Multidisciplinary treatment had improved functional status, physical activity level, and exercise regularity. The functional improvements were maintained 1 year after treatment completion.
<b>INTRODUCTION: </b>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.<b>DESIGN: </b>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.<b>Setting/participants: </b>One hundred and fifty military veterans with cLBP were recruited from a major Veterans Affairs Medical Center in California.<b>Intervention: </b>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.<b>MAIN OUTCOME MEASURES: </b>The primary outcome was Roland-Morris Disability Questionnaire scores after 12 weeks. Pain intensity was identified as an important secondary outcome.<b>RESULTS: </b>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.<b>CONCLUSIONS: </b>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.<b>Trial Registration: </b>This study is registered at www.clinicaltrials.gov NCT02524158.
OBJECTIVE: This study aims to provide evidence regarding the clinical efficacy of abdominal acupuncture for neck pain.
METHODS: This randomized, patient and assessor-blind, sham-controlled trial was conducted at a Chinese medicine center in Hong Kong between November 2014 and March 2016. A total of 154 eligible participants (age range, 18-65 years) with neck pain were randomly assigned to receive abdominal (n = 77) or non-penetrating sham abdominal (sham group; n = 77) acupuncture. Each participant was administered treatment over six sessions by Registered Chinese Medicine Practitioners, in accordance with a standardized protocol. The primary outcome was mean improvement in neck pain disability scores evaluated by the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes included intensity of neck pain and health-related quality-of-life measures. The outcomes were assessed at baseline and at 2 and 6 weeks from baseline. Patients in the abdominal acupuncture group received additional follow-up evaluation at 14 weeks from baseline. Outcomes were evaluated by intention-to-treat analysis.
RESULTS: All participants provided informed consent for treatment and follow-up evaluation. Patients who received abdominal acupuncture exhibited greater improvement in NPQ scores than those who received sham treatment at both 2 and 6 weeks from baseline (intergroup mean differences, -5.75; 95% confidence interval [CI], -9.48 to -2.03; P = 0.008 and -8.65; 95% CI, -12.13 to -5.16; P < 0.001, respectively). The improvement in NPQ scores in the abdominal acupuncture group was even more significant at 14 weeks from baseline. Patients in the abdominal acupuncture group also exhibited significantly greater improvements in intensity of neck pain and a few quality-of-life measures than those in the sham abdominal acupuncture group, without any serious adverse events.
CONCLUSION: These findings suggest that abdominal acupuncture is an effective alternative treatment for neck pain.
TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-14004932.
OBJECTIVES: To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia.
METHODS: Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks.
RESULTS: Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (-41.0%, 95% CI -47.2% to -34.8%) than in the SA group (-27.1%, 95% CI -33.2% to -20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: -19.9%, 95% CI -24.6% to -15.1%; vs SA: -6.2%, 95% CI -11.2% to -1.2%).
CONCLUSIONS: Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended.
TRIAL REGISTRATION NUMBER: ISRCTN60217348.
<b>Importance: </b>Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.<b>OBJECTIVE: </b>To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.<b>Design, Setting, and Participants: </b>Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113).<b>INTERVENTIONS: </b>CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.<b>Main Outcomes and Measures: </b>Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.<b>RESULTS: </b>There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.<b>Conclusions and Relevance: </b>Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.<b>Trial Registration: </b>clinicaltrials.gov Identifier: NCT01467843.
