Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.
ABSTRACT: Background: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. Objective:To determine whether yoga is noninferior to PT for cLBP. Design:12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). Setting:Academic safety-net hospital and 7 affiliated community health centers. Participants:320 predominantly low-income, racially diverse adults with nonspecific cLBP. Intervention: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. Measurements: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. Results: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. Limitations:Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. Conclusion:A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. Primary Funding Source:National Center for Complementary and Integrative Health of the National Institutes of Health.
Project description: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.
Project description:OBJECTIVES:To assess if body function, activity, participation, health-related quality of life and lifestyle behavioural factors can predict activity limitation in women with chronic low back pain (CLBP) in primary healthcare (PHC) 2?years later. DESIGN:A 2-year prospective longitudinal cohort study within PHC. SETTINGS:PHC in southwestern Sweden. PARTICIPANTS:The cohort comprised 130 women with CLBP attending PHC at baseline 2004-2005 and were reassessed after 2?years. MEASURES:The dependent outcome variable was self-reported activity limitation (Roland Morris disability questionnaire (RMDQ)) at 2-year follow-up. Independent predictors at baseline were age, body mass index, smoking, alcohol consumption, sleep quantity and quality, leisure time physical activity, a questionnaire of clinical manifestation of stress (Stress and Crises Inventory (SCI-93)), pain localisation, pain intensity, fatigue, anxiety, depression, RMDQ, work status, private social support, health-related quality of life and measures of physical performance specified as 6?min walk test (6MWT) and hand grip strength. Relation between baseline predictors and variation in later self-reported activity limitation (RMDQ) was analysed using multivariate linear regression. RESULTS:Ninety-five per cent (n=123/130) were followed up after 2?years. The participants were middle-aged (mean 45 (SD 10) years), mostly educated >9 years (88%; 108/123), mainly living with another adult (76%; 93/122) and born in Sweden (90%; 111/123). Seventy-nine per cent (97/123) were categorised as having work ability at baseline. The final prognostic model including 6MWT, SCI-93 and RMDQ at baseline explained 54% of the variance in self-reported activity limitation (RMDQ) at the 2-year follow-up. CONCLUSIONS:Lower physical performance, more severe clinical stress symptoms and more severe activity limitation predicted activity limitation after 2?years in women with CLBP within PHC. The results can give guidance for interventional trials aiming to improve physical capacity and decrease stress. The impact of the interaction between prognostic factors and interventions on activity limitation needs further investigation.
Project description:BACKGROUND:A substantial number of patients with chronic low back pain (CLBP) have axial spondyloarthritis (axSpA), but early recognition of these patients is difficult for general practitioners (GPs). The Case Finding Axial Spondyloarthritis (CaFaSpA) referral strategy has shown to be able to identify patients with CLBP at risk for axSpA, but its impact on clinical daily practice is yet unknown. OBJECTIVE:To assess the effect of the CaFaSpA referral strategy on pain caused by disability in primary care patients with CLBP. METHODS:Within this clustered randomized controlled trial 93 general practices were randomized to either the CaFaSpA referral model (intervention) or usual primary care (control). In each group primary care patients between 18 and 45 years with CLBP were included. The primary outcome was disability caused by CLBP, measured with the Roland Morris Disability Questionnaire (RMDQ) at baseline and four months. Secondary outcome was the frequency of new axSpA diagnosis. Descriptive analyses were performed, and a linear mixed-effects model was used. RESULTS:In total 679 CLBP patients were included of which 333 patients were allocated to the intervention group and 346 to the control group. Sixty-four percent were female and mean age was 36.2 years. The mean RMDQ score at baseline was 8.39 in the intervention group and 8.61 in the control group. At four months mean RMDQ score was 7.65 in the intervention group and 8.15 in the control group. This difference was not statistically significant (p = 0.50). Six (8%) out of the 75 finally referred patients, were diagnosed with axSpA by their rheumatologist. CONCLUSIONS:The CaFaSpA referral strategy for axSpA did not have an effect on disability after four months caused by CLBP. However, the strategy is able to detect the axSpA patient within the large CLBP population sufficiently. Trial registration number: NCT01944163, Clinicaltrials.gov.
Project description:Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP) in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n = 49) versus twice-weekly (n = 46) standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale) and back-related function (23-point modified Roland-Morris Disability Questionnaire). Results. 82% of participants were nonwhite; 77% had annual household incomes <$40,000. The sample's baseline mean pain intensity [6.9 (SD 1.6)] and function [13.7 (SD 5.0)] reflected moderate to severe back pain and impairment. Pain and back-related function improved within both groups (P < 0.001). However, there were no differences between once-weekly and twice-weekly groups for pain reduction [-2.1 (95% CI -2.9, -1.3) versus -2.4 (95% CI -3.1, -1.8), P = 0.62] or back-related function [-5.1 (95% CI -7.0, -3.2) versus -4.9 (95% CI -6.5, -3.3), P = 0.83]. Conclusions. Twelve weeks of once-weekly or twice-weekly yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.
Project description:PURPOSE:Walking and mind-body therapies (MBTs) are commonly recommended to relieve pain and improve function in patients with chronic low back pain (CLBP). The purpose of this study was to compare the effectiveness of walking and MBTs in CLBP. METHODS:We included randomized controlled trials (RCTs) comparing walking or MBTs to any other intervention or control in adults with CLBP. Studies were identified through PubMed, Cochrane Library, PsycINFO, Scopus, and ScienceDirect databases. The research was limited to studies published in English and French between January 2008 and December 2018. Two reviewers independently selected the studies, extracted data, and assessed studies quality using the Physiotherapy Evidence Database (PEDro) scale. Statistical analyses were performed under a random-effects model. We analyzed pain and activity limitation, with the calculation of standardized mean differences and 95% confidence intervals for the different treatment effects. RESULTS:Thirty one randomized controlled trials involving 3193 participants were analyzed. Walking was as effective as control interventions in the short-term and slightly superior in the intermediate term with respect to pain (Standardized mean differences (SMD) ?=?-0.34; 95% CI, -0.65 to -0.03; P?=?.03) and activity limitation (SMD?=?-0.30; 95% CI, -0.50 to -0.10; P?=?.003). In contrast, yoga was more effective than control interventions in the short term in terms of pain (SMD?=?-1.47; 95% CI, -2.26 to -0.68; P?=?.0003) and activity limitation (SMD?=?-1.17; 95% CI, -1.80 to -0.55; P?=?.0002). Yoga was no longer superior to the control interventions for pain at the 6-month follow-up. CONCLUSION:MBTs, especially yoga, seem to be more effective in the short term, and walking seems to be more effective in the intermediate term, for the relief of pain and activity limitation in patients with CLBP. A combination of walking and MBTs fits the biopsychosocial model and might be valuable therapy for CLBP throughout follow-up due to combined effects.
Project description:Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown.This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data.This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.
Project description:Methodological study nested within a multicentre randomised controlled trial (RCT) of yoga plus usual general practitioner (GP) care vs usual GP care for chronic low back pain.To explore the treatment effects of non-compliance using three approaches in an RCT evaluating yoga for low back pain.A large multicentre RCT using intention-to-treat (ITT) analysis found that participants with chronic low back pain who were offered a 12-week progressive programme of yoga plus usual GP care had better back function than those offered usual GP care alone. However, ITT analysis can underestimate the effect of treatment in those who comply with treatment. As such, the data were analysed using other approaches to assess the problem of non-compliance. The main outcome measure was the self-reported Roland Morris Disability Questionnaire (RMDQ).Complier average causal effect (CACE) analysis, per-protocol analysis and on-treatment analysis were conducted on the data of participants who were fully compliant, predefined as attendance of at least three of the first six sessions and at least three other sessions. The analysis was repeated for participants who had attended at least one yoga session (i.e. any compliance), which included participants who were fully compliant. Each approach was described, including strengths and weaknesses, and the results of the different approaches were compared with those of the ITT analysis.For the participants who were fully compliant (n=93, 60%), a larger beneficial treatment effect was seen using CACE analysis compared with per-protocol, on-treatment and ITT analyses at 3 and 12 months. The difference in mean change in RMDQ score between randomised groups was -3.30 [95% confidence interval (CI) -4.90 to -1.70, P<0.001] at 3 months and -2.23 (95% CI -3.93 to -0.53, P=0.010) at 12 months for CACE analysis, -3.12 (95% CI -4.26 to -1.98, P<0.001) at 3 months and -2.11 (95% CI -3.33 to -0.89, P=0.001) at 12 months for per-protocol analysis, and -2.91 (95% CI -4.06 to -1.76, P<0.001) at 3 months and -2.10 (95% CI -3.31 to -0.89, P=0.001) at 12 months for on-treatment analysis. For the participants who demonstrated any compliance (n=133, 85%), the results were generally consistent with the fully compliant group at 3 months, but the treatment effect was smaller. The difference in mean change in RMDQ score between randomised groups was -2.45 (95% CI -3.67 to -1.24) for CACE analysis, -2.30 (95% CI -3.43 to 1.17) for per-protocol analysis and -2.15 (95% CI -3.25 to -1.06) for on-treatment analysis, which was slightly less than that for ITT analysis. In contrast, at 12 months, per-protocol and on-treatment analyses showed a larger treatment effect compared with CACE and ITT analyses: per protocol analysis -1.86 (95% CI -3.02 to -0.71), on-treatment analysis -1.99 (95% CI -3.13 to -0.86) and CACE analysis -1.67 (95% CI -2.95 to -0.40).ITT analysis estimated a slightly smaller treatment effect in participants who complied with treatment. When examining compliance, CACE analysis is more rigorous than per-protocol and on-treatment analyses. Using CACE analysis, the treatment effect was larger in participants who complied with treatment compared with participants who were allocated to treatment, and the difference between ITT and CACE analyses for the fully compliant group at 3 months was small but clinically important. Per-protocol and on-treatment analyses may produce unreliable estimates when the effect of treatment is small.ISRCTN 81079604.
Project description:Importance:Despite recent studies suggesting arthroscopic partial meniscectomy (APM) is not more effective than physical therapy (PT), the procedure is still frequently performed in patients with meniscal tears. Objective:To assess whether PT is noninferior to APM for improving patient-reported knee function in patients with meniscal tears. Design, Setting, and Participants:Noninferiority, multicenter, randomized clinical trial conducted in 9 hospitals in the Netherlands. Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint). Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded. Recruitment took place between July 17, 2013, and November 4, 2015. Participants were followed up for 24 months (final participant follow-up, October 11, 2017). Interventions:Three hundred twenty-one participants were randomly assigned to APM (n?=?159) or a predefined PT protocol (n?=?162). The PT protocol consisted of 16 sessions of exercise therapy over 8 weeks focused on coordination and closed kinetic chain strength exercises. Main Outcomes and Measures:The primary outcome was change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100; from worse to best) from baseline over a 24-month follow-up period. The noninferiority margin was defined as a difference between treatment groups of 8 points and was assessed with a 1-sided ? of .025. The primary analysis followed the intention-to-treat principle. Results:Among 321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men). In the PT group, 47 participants (29%) had APM during the 24-month follow-up period, and 8 participants randomized to APM (5%) did not have APM. Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7). The overall between-group difference was 3.6 points (97.5% CI, -? to 6.5; P value for noninferiority?=?.001). Adverse events occurred in 18 participants in the APM group and 12 in the PT group. Repeat surgery (3 in the APM group and 1 in the PT group) and additional outpatient visits for knee pain (6 in the APM group and 2 in the PT group) were the most frequent adverse events. Conclusions and Relevance:Among patients with nonobstructive meniscal tears, PT was noninferior to APM for improving patient-reported knee function over a 24-month follow-up period. Based on these results, PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears. Trial Registration:ClinicalTrials.gov Identifier: NCT01850719.
Project description:BACKGROUND: Chronic pain can disrupt the cortical representation of a painful body part. This disruption may play a role in maintaining the individual's pain. Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions. However, there is little evidence for the effectiveness of this intervention for chronic low back pain (CLBP). The primary aim of this study was to inform the development of a fully powered randomised controlled trial (RCT) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP. The secondary aim was to obtain qualitative feedback about the intervention. METHODS: In this mixed-methods pilot RCT 15 individuals were randomised to either an intervention (tactile acuity training) or a placebo group (sham tactile acuity training). All participants received 3 sessions of acuity training (intervention or sham) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer (friend/relative). All participants also received usual care physiotherapy. The primary outcome measures were pain (0-100visual analogue scale (VAS)) and function (Roland Morris Disability Questionnaire (RMDQ)). Participants and their informal carers were invited to a focus group to provide feedback on the intervention. RESULTS: The placebo group improved by the greatest magnitude for both outcome measures, but there was no statistically significant difference (Mean difference (95%CI), p-value) between groups for change in pain (25.6 (-0.7 to 51.9), p = 0.056) or function (2.2 (-1.6 to 6.0), p = 0.237). Comparing the number of individuals achieving a minimally clinically significant improvement, the placebo group had better outcomes for pain with all participants achieving ?30% improvement compared to only a third of the intervention group (6/6 vs. 3/9, p = 0.036). Qualitatively, participants reported that needing an informal carer was a considerable barrier to the home training component of the study. CONCLUSIONS: This pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP. That the intervention could not be self-applied was a considerable barrier to its use. TRIAL REGISTRATION ISRCTN: ISRCTN98118082.
Project description:OBJECTIVES:A number of factors, including heritability and the environment, contribute to risk of transition from acute low back pain to chronic low back pain (CLBP). The aim of this study was to (1) compare somatosensory function and pain ratings at low back pain (LBP) onset between the acute low back pain and CLBP conditions and (2) evaluate associations between BDNF and COMT polymorphisms and expression levels at LBP onset to acute and chronic pain burden and risk for transition to the chronic pain state. METHODS:In this longitudinal study, 220 participants were enrolled following recent onset of LBP and data were collected until the LBP resolved or until the end of the study at 6 months. Forty-two participants' pain resolved before 6 weeks from onset and 42 participants continued to have pain at 6 months. Patient-reported pain burden, somatosensory function (quantitative sensory testing), and blood samples were collected at each study visit. RESULTS:CLBP is associated with greater pain burden and somatosensory hypersensitivity at the time of LBP onset. COMT rs4680 genotype (GG) was associated with acute cold pain sensitivity and with the risk for transition to CLBP while COMT expression was independently associated with risk for transition. DISCUSSION:CLBP was characterized by higher reported pain burden and augmented hypersensitivity at LBP onset. COMT expression and genotype were associated with acute pain burden and likelihood of transition to CLBP.