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.

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.

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.

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.

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.

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.

Individual-Level and Neighborhood-Level Factors Associated with Longitudinal Changes in Cardiometabolic Measures in Participants of a Clinic-Based Care Coordination Program: A Secondary Data Analysis.

Background: Identifying individual and neighborhood-level factors associated with worsening cardiometabolic risks despite clinic-based care coordination may help identify candidates for supplementary team-based care. Methods: Secondary data analysis of data from a two-year nurse-led care coordination program cohort of Medicare, Medicaid, dual-eligible adults, Leveraging Information Technology to Guide High Tech, High Touch Care (LIGHT2), from ten Midwestern primary care clinics in the U.S. Outcome Measures: Hemoglobin A1C, low-density-lipoprotein (LDL) cholesterol, and blood pressure. Multivariable generalized linear regression models assessed individual and neighborhood-level factors associated with changes in outcome measures from before to after completion of the LIGHT2 program. Results: 6378 participants had pre-and post-intervention levels reported for at least one outcome measure. In adjusted models, higher pre-intervention cardiometabolic measures were associated with worsening of all cardiometabolic measures. Women had worsening LDL-cholesterol compared with men. Women with pre-intervention HbA1c > 6.8% and systolic blood pressure > 131 mm of Hg had worse post-intervention HbA1c and systolic blood pressure compared with men. Adding individual's neighborhood-level risks did not change effect sizes significantly. Conclusions: Increased cardiometabolic risks and gender were associated with worsening cardiometabolic outcomes. Understanding unresolved gender-specific needs and preferences of patients with increased cardiometabolic risks may aid in tailoring clinic-community-linked care planning.

Doctors of chiropractic working with or within integrated healthcare delivery systems: a scoping review protocol.

INTRODUCTION: Back and neck pain are the leading causes of disability worldwide. Doctors of chiropractic (DCs) are trained to manage these common conditions and can provide non-pharmacological treatment aligned with international clinical practice guidelines. Although DCs practice in over 90 countries, chiropractic care is rarely available within integrated healthcare delivery systems. A lack of DCs in private practice, particularly in low-income communities, may also limit access to chiropractic care. Improving collaboration between medical providers and community-based DCs, or embedding DCs in medical settings such as hospitals or community health centres, will improve access to evidence-based care for musculoskeletal conditions. METHODS AND ANALYSES: This scoping review will map studies of DCs working with or within integrated healthcare delivery systems. We will use the recommended six-step approach for scoping reviews. We will search three electronic data bases including Medline, Embase and Web of Science. Two investigators will independently review all titles and abstracts to identify relevant records, screen the full-text articles of potentially admissible records, and systematically extract data from selected articles. We will include studies published in English from 1998 to 2020 describing medical settings that have established formal relationships with community-based DCs (eg, shared medical record) or where DCs practice in medical settings. Data extraction and reporting will be guided by the Proctor Conceptual Model for Implementation Research, which has three domains: clinical intervention, implementation strategies and outcome measurement. Stakeholders from diverse clinical fields will offer feedback on the implications of our findings via a web-based survey. ETHICS AND DISSEMINATION: Ethics approval will not be obtained for this review of published and publicly accessible data, but will be obtained for the web-based survey. Our results will be disseminated through conference presentations and a peer-reviewed publication. Our findings will inform implementation strategies that support the adoption of chiropractic care within integrated healthcare delivery systems.

Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial.

BACKGROUND: Many patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability. METHODS: We conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute LBP were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Trial Registry: ClinicalTrials.gov NCT02647658. FINDINGS: Between May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n = 658) versus 51% of patients in the control arm (35 practices, n = 635; OR=0.83 95% CI 0.64, 1.09; p = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9-0.6; p = 0.12). Opioids and imaging were prescribed in 22%-25% and 23%-26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups. INTERPRETATION: There were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines. FUNDING: Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867.

Matching Our Mission: A Strategic Plan to Create a Diverse Family Medicine Residency.

BACKGROUND AND OBJECTIVES: Increasing the number of underrepresented minority (URM) physicians improves access and quality of care. URMs are more likely to practice primary care and work in underserved communities. The racial and ethnic diversity of family physicians lags behind the general population. To create a more diverse residency, the Boston Medical Center Family Medicine Residency Program (BMCFMRP) developed, implemented, and evaluated a strategic plan for diversity recruitment. METHODS: In academic year (AY) 2014-2015, we set goals to increase the number of URM applicants and the percentage of matched URMs. From 2014-2017, we implemented an intervention focused on: (1) increasing outreach to URM candidates, (2) revising interviews to minimize bias, and (3) analyzing recruitment data. RESULTS: From 2014-2017, the total number of URM applicants increased by 80% (61 to 110). Evaluating recruitment trends from 2010-2017, there was a statistically significant increase (P<0.001) in the percentage of URM applicants from 13.3% (29 of 218 total applicants) to 19.9% (110 of 402). There was also a significant increase (P=0.029) in the percentage of matched URMs. Before the intervention, the percentage ranged from 0% to 20% (2011: 0% [n=0/6], 2014: 0% [n=0/10], 2013: 20% [n=2/10]). During the intervention, the percentage ranged from 25% to 50% (2017: 25% [n=3/12], 2016: 50% [n=6/12]). CONCLUSIONS: The implementation of a strategic plan for diversity recruitment increased the number of URM applicants and the percentage of URMs matching into the BMCFMRP. Additional research is needed to determine if these strategies produce similar results in residency programs at other institutions and in other medical specialties.

Integrative Medicine in a Preventive Medicine Residency: A Program for the Urban Underserved.

The Preventive Medicine Residency Program collaborated with the Department of Family Medicine's Program for Integrative Medicine and Health Disparities at Boston Medical Center to create a new rotation for preventive medicine residents starting in autumn 2012. Residents participated in integrative medicine group visits and consults, completed an online curriculum in dietary supplements, and participated in seminars all in the context of an urban safety net hospital. This collaboration was made possible by a federal Health Resources and Services Administration grant for integrative medicine in preventive medicine residencies and helped meet a need of the program to increase residents' exposure to clinical preventive medicine and integrative health clinical skills and principles. The collaboration has resulted in a required rotation for all residents that continues after the grant period and has fostered additional collaborations related to integrative medicine across the programs.

Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial.

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.