Yoga Versus Education for Veterans with Chronic Low Back Pain: a Randomized Controlled Trial.

BACKGROUND: Yoga is effective for chronic low back pain (cLBP) in civilians but understudied among Veterans. OBJECTIVE: Determine whether yoga is more effective than an educational book for improving disability and pain among Veterans with cLBP. DESIGN, SETTING, AND PARTICIPANTS: Veterans diagnosed with cLBP at a VA medical center enrolled in a randomized controlled trial from March to December of 2015. INTERVENTIONS: Twelve weekly hatha yoga classes or education using The Back Pain Helpbook. MEASURES: Co-primary outcomes were changes from baseline at 12 weeks in back-related disability on the modified Roland Morris Disability Questionnaire and pain on the Defense & Veterans Pain Rating Scale. Secondary outcomes were global improvement, patient satisfaction, pain medication use, and post-traumatic stress symptoms. An intention-to-treat approach was used in primary analyses. RESULTS: One hundred twenty Veterans (mean age, 55.5 [SD = 16.9]; 11 [9%] women; mean number of chronic conditions, 5.5) were randomized to yoga (n = 62) and education (n = 58). At 12 weeks, reductions in back-related disability in yoga (mean difference [MD] = - 3.50, 95% CI: - 5.03, - 1.97) were not significantly different than education (MD = - 2.55, 95% CI: - 4.10, - 0.99; between-group difference: - 0.95 [95% CI: - 3.14, 1.23], p = 0.39). For pain, there was no significant difference between yoga (MD = - 1.01, 95% CI: - 1.67, - 0.35) and education (MD = - 0.81, 95% CI: - 1.36, - 0.27; between-group difference: - 0.20, 95% CI: - 1.06, 0.66, p = 0.65). More yoga than education participants reported being very much or extremely improved (39% vs 19%, OR = 3.71, 95% CI: 1.37, 10.02, p = 0.01) and very satisfied with treatment (60% vs 31%, OR = 4.28, 95% CI: 1.70, 10.77, p = 0.002). No differences in pain medication use or post-traumatic stress symptoms were observed at 12 weeks. No serious adverse events were reported in either group. CONCLUSION: Twelve weekly yoga classes were not more effective than an education intervention for improving pain or disability outcomes among mostly older male Veterans with cLBP and multiple comorbid health conditions. GOV IDENTIFIER: NCT02224183.

Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study.

OBJECTIVE: We assessed whether race or ethnicity was associated with the incidence of high-impact chronic low back pain (cLBP) among adults consulting a primary care provider for acute low back pain (aLBP). METHODS: In this secondary analysis of a prospective cohort study, patients with aLBP were identified through screening at seventy-seven primary care practices from four geographic regions. Incidence of high-impact cLBP was defined as the subset of patients with cLBP and at least moderate disability on Oswestry Disability Index [ODI >30]) at 6 months. General linear mixed models provided adjusted estimates of association between race/ethnicity and high-impact cLBP. RESULTS: We identified 9,088 patients with aLBP (81.3% White; 14.3% Black; 4.4% Hispanic). Black/Hispanic patients compared to White patients, were younger and more likely to be female, obese, have Medicaid insurance, worse disability on ODI, and were at higher risk of persistent disability on STarT Back Tool (all P < .0001). At 6 months, more Black and Hispanic patients reported high-impact cLBP (30% and 25%, respectively) compared to White patients (15%, P < .0001, n = 5,035). After adjusting for measured differences in socioeconomic and back-related risk factors, compared to White patients, the increased odds of high-impact cLBP remained statistically significant for Black but not Hispanic patients (adjusted odds ration [aOR] = 1.40, 95% confidence interval [CI]: 1.05-1.87 and aOR = 1.25, 95%CI: 0.83-1.90, respectively). CONCLUSIONS: We observed an increased incidence of high-impact cLBP among Black and Hispanic patients compared to White patients. This disparity was partly explained by racial/ethnic differences in socioeconomic and back-related risk factors. Interventions that target these factors to reduce pain-related disparities should be evaluated. CLINICALTRIALS.GOV IDENTIFIER: NCT02647658.

Health Remedies as a Source of Lead, Mercury, and Arsenic Exposure, New York City, 2010-2019.

Objectives. To describe the types of health remedies collected during poisoning investigations in New York City over a 10-year period that were found to contain high levels of lead, mercury, or arsenic. Methods. Between 2010 and 2019, the New York City Department of Health and Mental Hygiene collected 584 samples of health remedies during poisoning investigations and store surveys for lead, mercury, or arsenic analysis. Results. There was a significant association between blood lead levels and estimated cumulative daily lead exposures among adult users of rasa shastra Ayurvedic medications. Also, average blood lead levels among adult rasa shastra users were significantly higher than levels among those using other types of non-Ayurvedic health remedies. Conclusions. Rasa shastra Ayurvedic medications can contain very high levels of lead, mercury, and arsenic. This underscores the importance of screening for lead, mercury, and arsenic exposures within at-risk populations. Public Health Implications. The general ease of accessibility to rasa shastra medications raises concerns. There is a need for systemic change that results in primary prevention, that is, removal of the source through policy development and regulatory enforcement in the country of origin. (Am J Public Health. 2022;112(S7):S730-S740. https://doi.org/10.2105/AJPH.2022.306906).

Changes in Pain Self-Efficacy, Coping Skills, and Fear-Avoidance Beliefs in a Randomized Controlled Trial of Yoga, Physical Therapy, and Education for Chronic Low Back Pain.

OBJECTIVE: We evaluated exercise interventions for cognitive appraisal of chronic low back pain (cLBP) in an underserved population. METHODS: We conducted a secondary analysis of the Back to Health Trial, showing yoga to be noninferior to physical therapy (PT) for pain and function outcomes among adults with cLBP (n = 320) recruited from primary care clinics with predominantly low-income patients. Participants were randomized to 12 weeks of yoga, PT, or education. Cognitive appraisal was assessed with the Pain Self-Efficacy Questionnaire (PSEQ), Coping Strategies Questionnaire (CSQ), and Fear-Avoidance Beliefs Questionnaire (FABQ). Using multiple imputation and linear regression, we estimated within- and between-group changes in cognitive appraisal at 12 and 52 weeks, with baseline and the education group as references. RESULTS: Participants (mean age = 46 years) were majority female (64%) and majority Black (57%), and 54% had an annual household income <$30,000. All three groups showed improvements in PSEQ (range 0-60) at 12 weeks (yoga, mean difference [MD] = 7.0, 95% confidence interval [CI]: 4.9, 9.0; PT, MD = 6.9, 95% CI: 4.7 to 9.1; and education, MD = 3.4, 95% CI: 0.54 to 6.3), with yoga and PT improvements being clinically meaningful. At 12 weeks, improvements in catastrophizing (CSQ, range 0-36) were largest in the yoga and PT groups (MD = -3.0, 95% CI: -4.4 to -1.6; MD = -2.7, 95% CI: -4.2 to -1.2, respectively). Changes in FABQ were small. No statistically significant between-group differences were observed on PSEQ, CSQ, or FABQ at either time point. Many of the changes observed at 12 weeks were sustained at 52 weeks. CONCLUSION: All three interventions were associated with improvements in self-efficacy and catastrophizing among low-income, racially diverse adults with cLBP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01343927.

Association of Back Pain with Mortality: a Systematic Review and Meta-analysis of Cohort Studies.

BACKGROUND: Back pain is the most common cause of disability worldwide. While disability generally is associated with greater mortality, the association between back pain and mortality is unclear. Our objective was to examine whether back pain is associated with increased mortality risk and whether this association varies by age, sex, and back pain severity. METHODS: A systematic search of published literature was conducted using PubMed, Web of Science, and Embase databases from inception through March 2019. We included English-language prospective cohort studies evaluating the association of back pain with all-cause mortality with follow-up periods >5 years. Three reviewers independently screened studies, abstracted data, and appraised risk of bias using the Quality in Prognosis Studies (QUIPS) tool. A random-effects meta-analysis estimated combined odds ratios (OR) and 95% confidence intervals (CI), using the most adjusted model from each study. Potential effect modification by a priori hypothesized factors (age, sex, and back pain severity) was evaluated with meta-regression and stratified estimates. RESULTS: We identified eleven studies with 81,337 participants. Follow-up periods ranged from 5 to 23 years. The presence of any back pain, compared to none, was not associated with an increase in mortality (OR, 1.06; 95% CI, 0.97 to 1.16). However, back pain was associated with mortality in studies of women (OR, 1.22; 95% CI, 1.02 to 1.46) and among adults with more severe back pain (OR, 1.26; 95% CI, 1.14 to 1.40). CONCLUSION: Back pain was associated with a modest increase in all-cause mortality among women and those with more severe back pain.

Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial.

PURPOSE: To identify baseline characteristics of adults with chronic low back pain (cLBP) that predict response (i.e., a clinically important improvement) and/or modify treatment effect across three nonpharmacologic interventions. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Academic safety net hospital and seven federally qualified community health centers. SUBJECTS: Adults with cLBP (N = 299). METHODS: We report patient characteristics that were predictors of response and/or modified treatment effect across three 12-week treatments: yoga, physical therapy [PT], and a self-care book. Using preselected characteristics, we used logistic regression to identify predictors of "response," defined as a ≥30% improvement in the Roland Morris Disability Questionnaire. Then, using "response" as our outcome, we identified baseline characteristics that were treatment effect modifiers by testing for statistical interaction (P < 0.05) across two comparisons: 1) yoga-or-PT vs self-care and 2) yoga vs PT. RESULTS: Overall, 39% (116/299) of participants were responders, with more responders in the yoga-or-PT group (42%) than the self-care (23%) group. There was no difference in proportion responding to yoga (48%) vs PT (37%, odds ratio [OR] = 1.5, 95% confidence interval = 0.88 - 2.6). Predictors of response included having more than a high school education, a higher income, employment, few depressive symptoms, lower perceived stress, few work-related fear avoidance beliefs, high pain self-efficacy, and being a nonsmoker. Effect modifiers included use of pain medication and fear avoidance beliefs related to physical activity (both P = 0.02 for interaction). When comparing yoga or PT with self-care, a greater proportion were responders among those using pain meds (OR = 5.3), which differed from those not taking pain meds (OR = 0.94) at baseline. We also found greater treatment response among those with lower (OR = 7.0), but not high (OR = 1.3), fear avoidance beliefs around physical activity. CONCLUSIONS: Our findings revealed important subgroups for whom referral to yoga or PT may improve cLBP outcomes.

Can Yoga or Physical Therapy for Chronic Low Back Pain Improve Depression and Anxiety Among Adults From a Racially Diverse, Low-Income Community? A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To determine and compare the effect of yoga, physical therapy (PT), and education on depressive and anxious symptoms in patients with chronic low back pain (CLBP). DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Academic safety net hospital and 7 community health centers. PARTICIPANTS: A total of 320 adults with CLBP. INTERVENTION: Yoga classes, PT sessions, or an educational book. OUTCOME MEASURE: Depression and anxiety were measured using the Patient Health Questionnaire and Generalized Anxiety Disorder 7-item Scale, respectively, at baseline, 12, and 52 weeks. We identified baseline and midtreatment (6-wk) factors associated with clinically meaningful improvements in depressive (≥3 points) or anxious (≥2 points) symptoms at 12 weeks. RESULTS: Participants (female=64%; mean age, 46.0±10.7 years) were predominantly non-White (82%), low-income (<$30,000/year, 59%), and had not received a college degree (71%). Most participants had mild or worse depressive (60%) and anxious (50%) symptoms. At 12 weeks, yoga and PT participants experienced modest within-group improvements in depressive symptoms (mean difference [MD]=-1.23 [95% CI, -2.18 to -0.28]; MD=-1.01 [95% CI, -2.05 to -0.03], respectively). Compared with the education group, 12-week differences were not statistically significant, although trends favored yoga (MD=-0.71 [95% CI, -2.22 to 0.81]) and PT (MD= -0.32 [95% CI, -1.82 to 1.18]). At 12 weeks, improvements in anxious symptoms were only found in participants who had mild or moderate anxiety at baseline. Independent of treatment arm, participants who had 30% or greater improvement in pain or function midtreatment were more likely to have a clinically meaningful improvement in depressive symptoms (odds ratio [OR], 1.82 [95% CI, 1.03-3.22]; OR, 1.79 [95% CI, 1.06-3.04], respectively). CONCLUSIONS: In our secondary analysis we found that depression and anxiety, common in this sample of underserved adults with CLBP, may improve modestly with PT and yoga. However, effects were not superior to education. Improvements in pain and function are associated with a decrease in depressive symptoms. More research is needed to optimize the integration of physical and psychological well-being in PT and yoga.

Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Poor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied. OBJECTIVE: Evaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Academic safety-net hospital and 7 affiliated community health centers. PARTICIPANTS: A total of 320 adults with cLBP. INTERVENTION: Twelve weekly yoga classes, 1-on-1 PT sessions, or an educational book. MAIN MEASURES: Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (> 3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks. KEY RESULTS: Among participants (mean age = 46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI > 5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD] = - 1.19, 95% confidence interval [CI] - 1.82, - 0.55) and PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) groups. Participants who reported a ≥ 30% improvement in pain or physical function at 6 weeks, compared with those who improved < 10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR] = 3.51, 95% CI 1.73, 7.11 and OR = 2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks. CONCLUSION: In a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01343927.

Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP. METHODS: We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data. RESULTS: Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses. CONCLUSIONS: Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.

Association of Initial Provider Type on Opioid Fills for Individuals With Neck Pain.

OBJECTIVE: To determine whether the initial care provider for neck pain was associated with opioid use for individuals with neck pain. DESIGN: Retrospective cohort study. SETTING: Marketscan research databases. PARTICIPANTS: Patients (N=427,966) with new-onset neck pain from 2010-2014. MAIN OUTCOME MEASURES: Opioid use was defined using retail pharmacy fills. We performed logistic regression analysis to assess the association between initial provider and opioid use. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using bootstrapping logistic models. We performed propensity score matching as a robustness check on our findings. RESULTS: Compared to patients with neck pain who saw a primary health care provider, patients with neck pain who initially saw a conservative therapist were 72%-91% less likely to fill an opioid prescription in the first 30 days, and between 41%-87% less likely to continue filling prescriptions for 1 year. People with neck pain who initially saw emergency medicine physicians had the highest odds of opioid use during the first 30 days (OR, 3.58; 95% CI, 3.47-3.69; P<.001). CONCLUSIONS: A patient's initial clinical contact for neck pain may be an important opportunity to influence subsequent opioid use. Understanding more about the roles that conservative therapists play in the treatment of neck pain may be key in unlocking new ways to lessen the burden of opioid use in the United States.

Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial.

BACKGROUND: Although risk-stratifying patients with acute lower back pain is a promising approach for improving long-term outcomes, efforts to implement stratified care in the US healthcare system have had limited success. The objectives of this process evaluation were to 1) examine variation in two essential processes, risk stratification of patients with low back pain and referral of high-risk patients to psychologically informed physical therapy and 2) identify barriers and facilitators related to the risk stratification and referral processes. METHODS: We used a sequential mixed methods study design to evaluate implementation of stratified care at 33 primary care clinics (17 intervention, 16 control) participating in a larger pragmatic trial. We used electronic health record data to calculate: 1) clinic-level risk stratification rates (proportion of patients with back pain seen in the clinic over the study period who completed risk stratification questionnaires), 2) rates of risk stratification across different points in the clinical workflow (front desk, rooming, and time with clinician), and 3) rates of referral of high-risk patients to psychologically informed physical therapy among intervention clinics. We purposively sampled 13 clinics for onsite observations, which occurred in month 24 of the 26-month study. RESULTS: The overall risk stratification rate across the 33 clinics was 37.8% (range: 14.7-64.7%). Rates were highest when patients were identified as having back pain by front desk staff (overall: 91.9%, range: 80.6-100%). Rates decreased as the patient moved further into the visit (rooming, 29.3% [range: 0-83.3%]; and time with clinician, 11.3% [range: 0-49.3%]. The overall rate of referrals of high-risk patients to psychologically informed physical therapy across the 17 intervention clinics was 42.1% (range: 8.3-70.8%). Barriers included staffs' knowledge and beliefs about the intervention, patients' needs, technology issues, lack of physician engagement, and lack of time. Adaptability of the processes was a facilitator. CONCLUSIONS: Adherence to key stratified care processes varied across primary care clinics and across points in the workflow. The observed variation suggests room for improvement. Future research is needed to build on this work and more rigorously test strategies for implementing stratified care for patients with low back pain in the US healthcare system. TRIAL REGISTRATION: Trial registration: ClinicalTrials.gov ( NCT02647658 ). Registered January 6, 2016.

Association of Back Pain with All-Cause and Cause-Specific Mortality Among Older Women: a Cohort Study.

BACKGROUND: The impact of back pain on disability in older women is well-understood, but the influence of back pain on mortality is unclear. OBJECTIVE: To examine whether back pain was associated with all-cause and cause-specific mortality in older women and mediation of this association by disability. DESIGN: Prospective cohort study. SETTING: The Study of Osteoporotic Fractures. PARTICIPANTS: Women aged 65 or older. MEASUREMENT: Our primary outcome, time to death, was assessed using all-cause and cause-specific adjusted Cox models. We used a four-category back pain exposure (no back pain, non-persistent, infrequent persistent, or frequent persistent back pain) that combined back pain frequency and persistence across baseline (1986-1988) and first follow-up (1989-1990) interviews. Disability measures (limitations of instrumental activities of daily living [IADL], slow chair stand time, and slow walking speed) from 1991 were considered a priori potential mediators. RESULTS: Of 8321 women (mean age 71.5, SD = 5.1), 4975 (56%) died over a median follow-up of 14.1 years. A higher proportion of women with frequent persistent back pain died (65.8%) than those with no back pain (53.5%). In the fully adjusted model, women with frequent persistent back pain had higher hazard of all-cause (hazard ratio [HR] = 1.24 [95% CI, 1.11-1.39]), cardiovascular (HR = 1.34 [CI, 1.12-1.62]), and cancer (HR = 1.33, [CI 1.03-1.71]) mortality. No association with mortality was observed for other back pain categories. In mediation analyses, IADL limitations explained 47% of the effect of persistent frequent back pain on all-cause mortality, slow chair stand time, and walking speed, explained 27% and 24% (all significant, p < 0.001), respectively. LIMITATIONS: Only white women were included. CONCLUSION: Frequent persistent back pain was associated with increased mortality in older women. Much of this association was mediated by disability.

Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.

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.

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P < 0.01) occurred in the yoga group; serious adverse events and dropouts due to adverse events were comparable between groups. Findings from this review indicate that yoga appears as safe as usual care and exercise. The adequate reporting of safety data in future randomized trials of yoga is crucial to conclusively judge its safety.

Lay advisor interventions for hypertension outcomes: A Systematic Review, Meta-analysis and a RE-AIM evaluation.

Introduction: Lay advisor interventions improve hypertension outcomes; however, the added benefits and relevant factors for their widespread implementation into health systems are unknown. We performed a systematic review to: (1) summarize the benefits of adding lay advisors to interventions on hypertension outcomes, and (2) summarize factors associated with successful implementation in health systems using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Methods: We systematically searched several databases, including Ovid MEDLINE, CINAHL, PsycINFO from January 1981 to May 2023. All study designs of interventions delivered solely by lay advisors for adults with hypertension were eligible. If both arms received the lay advisor intervention, the study arm with lower intensity was assigned as the low-intensity intervention. Results: We included 41 articles, of which 22 were RCTs, from 7,267 screened citations. Studies predominantly included socially disadvantaged populations. Meta-analysis (9 RCTs; n = 4,220) of eligible lay advisor interventions reporting outcomes showed improved systolic blood pressure (BP) [-3.72 mm Hg (CI -6.1 to -1.3; I2 88%)], and diastolic BP [-1.7 mm Hg (CI -1 to -0.9; I2 7%)] compared to control group. Pooled effect from six RCTs (n = 3,277) comparing high-intensity with low-intensity lay advisor interventions showed improved systolic BP of -3.6 mm Hg (CI -6.7 to -0.5; I2 82.7%) and improved diastolic BP of -2.1 mm Hg (CI -3.7 to -0.4; I2 70.9%) with high-intensity interventions. No significant difference in pooled odds of hypertension control was noted between lay advisor intervention and control groups, or between high-intensity and low-intensity intervention groups. Most studies used multicomponent interventions with no stepped care elements or reporting of efficacious components. Indicators of external validity (adoption, implementation, maintenance) were infrequently reported. Discussion: Lay advisor interventions improve hypertension outcomes, with high intensity interventions having a greater impact. Further studies need to identify successful intervention and implementation factors of multicomponent interventions for stepped upscaling within healthcare system settings as well as factors used to help sustain interventions.

Yoga-Based Interventions in Low-Income Populations: A Scoping Review.

Introduction: The popularity of yoga has surged in recent years; however, yoga practitioners have remained a largely homogenous population. Research reflects that most practitioners are of a higher socioeconomic status. There are access barriers to yoga for lower income individuals, likely due to factors such as financial constraints and logistical challenges. The primary goal of this review was to synthesize literature on yoga research among low-income populations and better understand the feasibility and acceptability of such interventions. A secondary goal was to assess the consistency of metrics for reporting feasibility and acceptability across such studies using the CheckList Standardizing the Reporting of Interventions for Yoga (CLARIFY) guidelines as a framework. Third, the authors sought to propose additional standardized CLARIFY guidelines that may enhance reporting on the diversity of yoga research populations, adherence, and retention. Methods: The electronic databases PubMed, PsycINFO, Cochrane Central Register of Controlled Trials, and Google Scholar were searched in May 2022 using a prespecified search string. Articles assessing a yoga intervention in predominantly low-income adult populations were deemed eligible for inclusion. Results: The search resulted in 512 potential articles. Eleven were deemed eligible for inclusion. The included studies reported mostly positive effects of yoga on the target outcome (i.e., pain/disability, quality of life/wellness, and psychiatric symptoms). Recruitment and retention data showed generally good attendance and high study completion rates. Common study design components included recruitment embedded within preexisting medical settings, proximal yoga locations, and mitigation of yoga-related costs. Finally, the authors noted inconsistency in the reporting of adherence, retention, and other sociodemographic characteristics of participants and yoga instructors (e.g., race, ethnicity, and income). Discussion: Yoga may promote physical and mental health for low-income individuals. Important facilitators to access are noted, such as proximal study settings, as well as barriers such as the need for childcare that can be addressed in future research. In addition, several study design considerations could help address the specific needs of low-income participants in yoga research, such as compensating participants, recruiting within existing medical settings, and providing yoga-related equipment at no cost. Finally, the authors suggest specific ways to enhance reporting of study metrics related to socioeconomic diversity, by adding to the preexisting CLARIFY guidelines.

Primary care barriers and facilitators to nonpharmacologic treatments for low back pain: A qualitative pilot study.

BACKGROUND: Clinical practice guidelines encourage primary care providers (PCPs) to recommend nonpharmacologic treatment as first-line therapy for low back pain (LBP). However, the determinants of nonpharmacologic treatment use for LBP in primary care remain unclear, particularly in low-income settings. OBJECTIVE: To pilot a framework-informed interview guide and codebook to explore determinants of nonpharmacologic treatment use in primary care. METHODS: In this qualitative interview study, we enrolled PCPs and community health workers (CHWs) from four primary care clinics at a safety net hospital. A semistructured interview guide informed by the Consolidated Framework for Implementation Research (CFIR) guided inquiry on barriers/facilitators to nonpharmacologic treatments for LBP (eg, acupuncture, chiropractic care, physical therapy). We included questions on whether current CHW roles may address barriers to nonpharmacologic treatment use. Interviews were audio-recorded, transcribed verbatim, and independently coded by four investigators. An a priori codebook composed of CFIR determinants and known CHW roles guided deductive content analysis to identify major themes. RESULTS: Eight individuals (six PCPs, two CHWs; age range: 32-51 years, five female) participated in hour-long interviews. Half had worked at the hospital for ≥15 years and all reported seeing patients with LBP (range: 2-20 patients per week). All participants identified the following CFIR factors as barriers/facilitators: nonpharmacologic treatment characteristics (perceived cost, relative advantage compared to other treatments); outer setting (patient needs/resources, limited connections with community-based nonpharmacologic treatment) and PCP characteristics (attitudes/beliefs about nonpharmacologic treatments). Although participants indicated several CHW roles could be adapted to address barriers (eg, care coordination, resource linking, case management), other roles seemed less feasible (eg, targeted health education) in our health care system. CONCLUSIONS: Preliminary insight on key determinants of nonpharmacologic treatments for LBP should be further examined in large multisite studies. Future studies may also determine whether a CHW-led strategy can improve nonpharmacologic treatment access and clinical outcomes in primary care.

Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framework.

BACKGROUND: Chronic pain affects up to half of individuals taking opioid agonist therapy (OAT; i.e., methadone and buprenorphine) for opioid use disorder (OUD), and yoga-based interventions may be useful for decreasing pain-related disability. Whereas more yoga practice (i.e., higher "dosage") may improve pain-related outcomes, it can be challenging for people with chronic pain taking OAT to attend class regularly and sustain a regular personal yoga practice. Therefore, we plan to optimize a yoga-based intervention (YBI) package in order to support class attendance and personal practice, thus maximizing the yoga dose received. STUDY DESIGN: Using the Multiphase Optimization Strategy (MOST) framework, we will conduct a factorial experiment to examine four intervention components that may be added to a weekly yoga class as part of a YBI. Components include: 1) personal practice videos featuring study yoga teachers, 2) two private sessions with a yoga teacher, 3) daily text messages to inspire personal practice, and 4) monetary incentives for class attendance. The primary outcome will be minutes per week engaged in yoga (including class attendance and personal practice). We plan to enroll 192 adults with chronic pain who are taking OAT for OUD in this 2x2x2x2 factorial experiment. CONCLUSION: Results of the study will guide development of an optimized yoga-based intervention package that maximizes dosage of yoga received. The final treatment package can be tested in a multisite efficacy trial of yoga to reduce pain interference in daily functioning in people with chronic pain who are taking OAT. TRIAL REGISTRATION: Pre-registration of the study was completed on ClinicalTrials.gov (identifier: NCT04641221).