Background Acupuncture is gaining popularity among cancer patients and providers for addressing cancer-related symptoms, including pain, fatigue, nausea, anxiety and depression. Most acupuncture research focuses on six- to eight-week interventions, with less known regarding short-duration, single-session treatments. Objectives To evaluate the preliminary effectiveness and acceptability of a single acupuncture treatment administered concurrently with cancer-directed infusion therapy. Methods We conducted a quality assessment/quality improvement (QA/QI) project of acupuncture for adults receiving infusion therapy at a US Midwest academic cancer center from October 2024 to April 2025. Patients received a single 20-minute acupuncture session. Questionnaires were completed pre/post treatment to assess acceptability, familiarity and prior use of acupuncture, and current symptoms. Results Of the 139 patients surveyed, 90 (64.8%) were female, 97 (69.8%) were married, 131 (94.2%) identified as non-Hispanic, and 117 (84.2%) as white. Most patients were between 50 to 69 years of age (59.0%) and had a solid tumor cancer diagnosis (56.8%). A high level of satisfaction was reported, with 107 (77.0%) being very satisfied with their visit. None of the participants reported being dissatisfied with their session. Thirty-two (23.0%) patients had prior acupuncture experience, while 96 (69.1%) expressed interest in receiving additional acupuncture in the infusion suite after initial treatment. Significant (p < 0.001) pre/post reductions in anxiety, depression, drowsiness, appetite loss, nausea, pain, shortness of breath, tiredness, and overall well-being were reported by participants. No significant adverse events were reported. Conclusion/Implications Single-session acupuncture delivered during infusion therapy was well-accepted by patients and resulted in significant reductions in several physical and psychological symptoms. Most participants expressed interest in receiving future acupuncture treatments. These findings underscore the need for further research to assess the long-term effects, scalability, and comparative effectiveness of integrative therapies, such as acupuncture, as part of a comprehensive supportive care plan for patients with cancer.
Background Persistent post-surgical pain, a chronic pain syndrome with few effective treatments, has spiked in recent years due to the increase in life expectancy and the number of surgical procedures performed. Studies have shown that non-pharmacological interventions, such as yoga, may help manage chronic pain, reducing pain severity and interference. Despite emerging evidence of the efficacy of yoga in managing chronic pain symptoms, rigorous studies evaluating its use in patients with persistent post-surgical pain have not been conducted. This study describes protocols used in Persistent Relief, an ongoing pilot randomized controlled trial comparing yoga to chronic pain health education. Results from a modified Delphi validation process used to adapt a yoga program for chronic low back pain to the unique needs of this patient population are also included. Methods/Design Fifty patients aged ≥18 with persistent post-surgical pain for at least 3 months and a mean pain severity of 4/10 on the Brief Pain Inventory are randomized to a 12-week yoga program (12, 75-minute sessions) or a chronic pain health education program (12, 15-30-minute sessions), followed by a 12-week follow-up period. Results of an iterative Delphi validation process led by an interdisciplinary expert panel indicated strong endorsement of the Yoga Program (across 7 experts and 9 questions; mean=6.7 [SD=0.64] on a 7-point Likert scale). Primary outcomes include pre-specified feasibility and acceptability metrics. Secondary outcomes include a battery of biopsychosocial measures, with the Brief Pain Inventory as the primary clinical outcome for a future fully powered trial. Discussion Results will provide preliminary data to inform modifications for a future fully powered study evaluating the efficacy of yoga integrated into the management of persistent post-surgical pain. Findings will also inform the design of future studies examining the biological mechanisms underlying the integrative use of yoga to prevent or resolve chronic pain syndromes. Clinicaltrials.gov identifier NCT06949007.
BACKGROUND:Chiropractic care for common musculoskeletal conditions such as low back pain typically includes guideline-concordant first-line nonpharmacologic treatments. However, geographic variability in access to chiropractic care and whether variability relates to neighborhood socioeconomic status (SES) is understudied. METHODS:In this geospatial analysis, we evaluated the association between neighborhood SES and the number of chiropractic providers in two U.S. geographic regions. Neighborhood SES was defined using the area deprivation index (ADI) for each neighborhood (defined as a census block group) in Suffolk County, MA, and Cuyahoga County, OH. Higher ADI scores (range 1-10) indicate worse neighborhood SES. Chiropractic providers were identified through triangulation of publicly available sources and geocoded to map provider locations. From each neighborhood centroid, we identified providers within nine catchment areas based on distance or travel times. Associations between ADI rank and the number of providers were evaluated using Poisson regression to estimate incident rate ratios (IRRs), adjusting for neighborhood population size. RESULTS:We identified 92 providers across 628 neighborhoods in Suffolk County and 214 providers across 1135 neighborhoods in Cuyahoga County. In Suffolk County, using the smallest distance-based catchment area (0.5 miles), compared to the low ADI tertile (mean = 3.9 providers), access was lower in the middle (mean = 1.3 providers; IRR = 0.31, 95% confidence intervals [CI] = 0.27-0.35) and high (mean = 0.9 providers; IRR = 0.21, 95% CI = 0.18-0.25) tertiles. We observed a similar graded association when considering broader catchment areas and those defined by walking and driving times. Results were similar in Cuyahoga County, although there was no difference in the middle tertile, and the association was attenuated in the high ADI tertile for individuals in the 15-min drive catchment area. CONCLUSIONS:Geographic areas with worse neighborhood SES had fewer chiropractic providers after controlling for population size. Further work is needed to evaluate and encourage equitable geographic distributions of chiropractic providers.
BACKGROUND:People taking medications for opioid use disorder (MOUD) commonly experience chronic pain. Yoga interventions show promise for decreasing pain-related disability in other populations. More time spent in yoga practice may improve pain-related outcomes. METHODS:The Multiphase Optimization Strategy (MOST) provided the framework for developing an optimized yoga intervention package. In a 2x2x2x2 factorial experiment, we evaluated four candidate intervention components which, when added to a weekly yoga class, might increase yoga engagement. The primary outcome was minutes per week of yoga practice (classes and other yoga practice) over the 12-week intervention period. We sought to determine which combination of intervention components was associated with the most yoga practice for people with chronic pain taking buprenorphine or methadone as MOUD. RESULTS:We enrolled 192 adults. There was a significant main effect for Component "B" (having two private sessions with a yoga teachers; IRR = 1.10, 90%CI 1.02; 1.18), and a synergistic interaction between Components "B" and "D" (D was financial incentives for attending class; IRR = 1.11, 90%CI 1.02; 1.19). This combination of these two components (without other potential components) was associated with the second highest model-predicted mean minutes of yoga per week (157.1min; 90% CI = 120.1-194.0) which was only 4min less than the combination including all four components. CONCLUSIONS:We identified a combination of intervention components as the optimized intervention. A next step will be to test the effect of this optimized intervention on pain and substance use outcomes in a randomized controlled clinical trial.
INTRODUCTION:Limited adoption of first line treatments for low back pain (LBP) in primary care settings may contribute to an overreliance on pain medications by primary care providers (PCPs). While chiropractic care typically includes recommended nonpharmacologic approaches (e.g., manual therapy, exercise instruction, advice on self-care), implementation strategies to increase adoption of chiropractic care for LBP in primary care clinics are understudied, particularly in underserved communities. METHODS:We will use a stepped-wedge cluster randomized controlled pilot trial design to evaluate the feasibility of a multi-level implementation strategy to increase adoption of chiropractic care for LBP in primary care clinics at community health centers. Key barriers and facilitators identified by site champions and other key stakeholders will help us to develop and tailor implementation strategies including educational materials and meetings, developing a network of local chiropractors, and modifying the electronic health record to facilitate referrals. Three primary care clinics will be randomized to receive the implementation strategy first, second, or third over a fourteen-month study period. At our first clinic, we will have a four-month pre-implementation period, a two-month implementation deployment period, and a subsequent eight-month follow-up period. We will stagger the start of our implementation strategy, beginning in a new clinic every two months. We will evaluate the proportion of patients with LBP who receive a referral to chiropractic care in the first 21 days after their index visit with PCP. We will also evaluate adoption of other guideline concordant care (e.g., other nonpharmacologic treatments) and non-guideline concordant care (e.g., opioids, imaging) over the study period. DISCUSSION:LBP is currently the leading cause of disability worldwide. While there are several treatment options available for individuals with LBP, patients in underserved populations do not often access recommended nonpharmacologic treatment options such as chiropractic care. The results from this study will inform the development of practical implementation strategies that may improve access to chiropractic care for LBP in the primary care context. Furthermore, results may also inform policy changes needed to expand access to chiropractic care in underserved communities. CLINTRIALS.GOV NCT#: NCT06104605.
e24048 Background: Acupuncture is an evidence-based integrative oncology treatment gaining popularity among cancer patients and providers for addressing cancer-related side effects. Acupuncture is included in several ASCO integrative oncology guidelines, including for pain management 1,2 , anxiety and depression 2,3 , stress 2 , chemotherapy-induced nausea and vomiting 2 , fatigue 2,4 , hot flashes 2 , and quality of life. 2 Most acupuncture research focuses on 6-8 week interventions, with less known regarding short-duration, single-session, interventions. This study explores the preliminary effectiveness and acceptability of a single acupuncture treatment administered concurrently with infusion therapy. Methods: We conducted a quality assessment/quality improvement (QA/QI) study of acupuncture for adults receiving infusion therapy at the Cleveland Clinic Taussig Cancer Center from October 1 – December 31, 2024. Patients received a single 20-minute acupuncture session during infusion therapy to address current symptoms and/or improve quality of life. Questionnaires were completed pre/post treatment to assess satisfaction (acceptability), familiarity and prior use of acupuncture, and current symptoms (Edmonton Symptom Assessment Survey (ESAS)). Descriptive statistics were used to summarize demographics and QA/QI outcomes. T-tests of mean differences were used to calculate p-values for the pre/post symptom change. Results: A total of 93 acupuncture treatments were administered. Most patients were female (61.2%), White (81.3%) with an average age of 59.6 years old (SD 11.6). Common diagnoses included breast cancer (18.7%), lymphoma (17.3%) and multiple myeloma (17.3%). Most patients never received acupuncture before (53%), were only somewhat familiar with acupuncture (31%), and 84% reported being very satisfied with treatment. We found significant (p<0.001) pre/post reductions in anxiety, depression, drowsiness, loss of appetite, nausea, pain, shortness of breath, tiredness, and a significant increase in wellbeing (Table). No significant adverse events were reported. Conclusions: This study supports the preliminary effectiveness and acceptability of short duration, single session, acupuncture concurrently with infusion therapy. Symptom change pre/post infusion suite acupuncture. Symptom t df p-value (2-tailed) Mean Difference 95% CI (Lower) 95% CI (Upper) Anxiety 8.53 92 <0.001 1.86 1.43 2.29 Depression 5.67 92 <0.001 1.06 0.69 1.44 Drowsiness 5.86 92 <0.001 1.45 0.96 1.94 Loss of Appetite 6.69 92 <0.001 1.27 0.89 1.65 Nausea 4.02 92 <0.001 0.75 0.38 1.12 Pain 5.32 92 <0.001 1.11 0.69 1.52 Shortness of Breath 5.69 92 <0.001 1.13 0.74 1.52 Tiredness 9.19 92 <0.001 2.02 1.58 2.46 Wellbeing 5.23 92 <0.001 1.28 0.79 1.76 T-tests of mean differences were used to calculate p-values, df = degrees of freedom, CI = confidence interval.
Background:The integrative medicine (IM) clinic is an innovative care model that may increase access to guideline-concordant nonpharmacologic treatment use in healthcare delivery systems for prevalent conditions such as low back pain (LBP). Objective:To describe the use and effectiveness of IM services for LBP in IM clinics. Research Design:Prospective cohort study. Subjects:Adult patients with LBP enrolled at seventeen IM clinics. Measures:Patterns of IM service use were assessed over 12 months. Changes in clinical outcomes were assessed between index visit and 12-month follow-up using linear mixed-effects models. Primary (pain interference, physical function) and secondary (pain intensity, anxiety, depression, fatigue, sleep disturbance, social participation) outcomes were obtained from the PROMIS-29 instrument. Results:We identified 660 participants with LBP (mean age = 51.6 years, 75% female). Over the 12-month study period, common IM services were IM consults (56%), acupuncture (44%), chiropractic care (24%), physical therapy (19%), and massage (17%). Over two-thirds (70%) of participants received at least one guideline-concordant nonpharmacologic treatment. Participants with follow-up outcome data (n = 443, 67%) reported a modest reduction in pain interference with life activities in the short- and long-term (2-month mean difference [MD] = -1.47, 95%CI = -2.98, -0.64; 12-month MD = -1.98, 95%CI = -3.12, -0.88). By contrast, improvements in physical function were not statistically or clinically significant (2-month MD = 0.37, 95%CI = -0.28, 1.01; 12-month MD = 0.69, 95%CI = -0.31, 1.69). At 12 months, small improvements were observed on all secondary outcomes (pain intensity, anxiety, depression, and social participation) except fatigue and sleep disturbance. Conclusions:Most patients with LBP receiving care at IM clinics received at least one guideline-recommended nonpharmacologic treatment. However, improvements on clinical outcomes were relatively small. Additional multi-site studies are needed to explore the optimal implementation approach.
Objective:Musculoskeletal disorders (MSDs) include different pathological conditions of the locomotor system, characterized by pain and limitations in mobility and functioning. The most frequent arthropathies include joint disorders and arthritis. Yoga is an ancient mind-body discipline which has received great attention in clinical research. This critical review intends to analyze the updated literature on clinical outcomes of yoga interventions for MSDs. Methods:Prospective clinical studies evaluating the effects of yoga for MSDs have been searched in Web of Sciences, Scopus and PubMed databases using yoga-related keywords in association with numerous disorders affecting the musculoskeletal system. We explored all protocols to identify similar movements or asana reported with different (uncommon) names or imprecise description, and to be useful for clinicians, we summarized yoga exercises with specific target for body areas and related pathologies. Results:Overall, 1150 articles were screened, among which 52 prospective clinical studies (total 4151 patients) were selected. The clinical outcomes of yoga were compared with active control groups (rehabilitation, drugs) or passive controls (self-care education or no intervention). The analysis was performed towards specific musculoskeletal disease, affected body area, study type, yoga protocol details, and outcomes in measured and self-reported parameters. All 52 studies showed marked benefits in every or some parameters: measurable outcomes as well as self-reported improvements were higher in yoga groups than in controls, and in some studies even better than drug therapy. Conclusions:This review highlights the potential benefits of yoga interventions for MSDs. Data highlights that yoga may help improve mobility, reduce reliance on medications, and enhance quality of life and could be considered as a complementary approach alongside conventional medical treatments. However, the heterogeneity of protocols, outcomes, and potential risks of bias highlight the need for rigorous trials to strengthen confidence in these findings and to identify the most effective protocols.
Purpose (the aim of the study): The American College of Rheumatology 2019 clinical practice guidelines strongly recommend Tai Chi, a multi-dimensional mind-body exercise, as an intervention for knee osteoarthritis (OA). Recent studies conducted during the pandemic suggest that web-administered remote Tai Chi is a promising and scalable strategy for knee OA pain. However, critical gaps remain regarding the real-world effectiveness of remote Tai Chi for knee OA and its implementation across multiple healthcare systems. Little is known about the barriers and facilitators to use remote Tai Chi interventions for knee OA in large healthcare delivery systems, particularly in primary care settings. Our aim is to identify multilevel barriers and facilitators to embed a remote Tai Chi intervention for knee OA pain across large healthcare systems.
Abstract Introduction Given the prevalence and staggering cost of neurological disorders, there is dire need for effective early detection and intervention tools. Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders. The objectives of this protocol are (1) to test the impact of MLI on the progression of neurological disorders and (2) to identify multi-omic biomarkers for early stages of neurological disease and the impact of MLIs on these biomarkers. Methods and analysis We present the Multidisciplinary lifestyle Interventions for Neurological Disorders during the Silent phase (MINDS) protocol, a randomized controlled trial of MLI in neurologically healthy older adults (≥ 50 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson’s Disease, or Alzheimer’s disease and related dementias. Participants will be randomly assigned to intervention (n = 100) or control (n = 100) groups. The intervention group will receive 3 months of weekly 2-hour sessions on diet education, yoga, music therapy, and cognitive skills training. The participants’ neurological health and engagement in relevant lifestyle practices will be assessed at regular intervals for 12 months. Neuroimaging and samples for multi-omic analyses will be collected at baseline, and at 3 months and 12 months after enrollment. Primary outcomes will be signs of progression of the neurological disorder risk that qualified them for study enrollment or a clinical diagnosis of the disorder. Secondary and exploratory outcomes will be based on self-reported health and multi-omic data. Data analysis will include between-group and longitudinal within-group analyses. Perspectives The MINDS protocol and trial aims to clarify the impact of MLI on the progression of neurological disorder risk or diagnosis in older adults and to identify biomarkers that can be used to confirm MLI efficacy. The ability to validate the impact of MLI on neurological disorder progression based on biomarker data allows the identification of individuals most likely to benefit from such therapies in the early stages of neurological disease. Trial registration The trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov (NCT05984056) site. It was registered on August 2nd, 2023. The trial has full approval of the Cleveland Clinic Internal Review Board.
IntroductionLay 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.MethodsWe 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.ResultsWe 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.DiscussionLay 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.
Importance Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice. Objective To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use. Design, Setting, and Participants Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days. Intervention Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes. Main Outcomes and Measures Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle. Results Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005). Conclusions and RelevanceResults of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option.
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.
Importance:Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice. Objective:To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use. Design, Setting, and Participants:Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days. Intervention:Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes. Main Outcomes and Measures:Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle. Results:Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005). Conclusions and Relevance:Results of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option. Trial Registration:ClinicalTrials.gov Identifier: NCT05319691.
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.
ABSTRACT Treatment effect modifiers identify patient characteristics associated with treatment responses. The purpose of this secondary analysis was to identify potential treatment effect modifiers for disability from the TARGET trial that compared usual care (control) to usual care + psychologically informed physical therapy (PIPT). The sample consisted of STarT Back tool identified high risk patients with acute low back pain that completed Oswestry Disability Index (ODI) data at index visit and 6 months later (n = 1,250). Candidate treatment effect modifiers were identified a-priori and informed by literature. Linear mixed models tested for treatment effect modification through tests of statistical interaction. All statistical interactions (P ≤ 0.20) were stratified by modifier to inspect for specific effects (P ≤ 0.05). Smoking was identified as a potential effect modifier (treatment*smoking interaction, P = 0.08). In participants who were smokers, the effect of PIPT was (ODI = 5.5; 95% CI: 0.6 - 10.4; P = 0.03) compared to usual care. In participants who were non-smokers, the effect of PIPT was (ODI = 1.5; 95% CI: -1.4 - 4.4; P = 0.31) compared to usual care. Pain medication was also identified as a potential effect modifier (treatment*pain medication interaction, P = 0.10). In participants prescribed ≥3 pain medications, the effect of PIPT was (ODI = 7.1; 95% CI: -0.1 - 14.2; P = 0.05) compared to usual care. The effect of PIPT for participants prescribed no pain medication was (ODI = 3.5; 95% CI: -0.4 - 7.4; P = 0.08) and for participants prescribed 1-2 pain medications was (ODI = 0.6; 95% CI: -2.5 - 3.7; P = 0.70) when compared to usual care. These findings may be used for generating hypotheses and/or planning future clinical trials investigating the effectiveness of tailored application of PIPT.
Introduction: The 1978 Alma Ata Declaration initiated international recognition of non-biomedical healing systems and their relevance for primary health. World Health Assembly (WHA) resolutions have called for the study and inclusion of traditional and complementary medicine (T&CM) into national health systems through policy development. The increased public, political, and scholarly attention given to T&CM has focused on clinical efficacy, cost-effectiveness, mechanisms of action, consumer demand, and supply-side regulation. Although >50% of WHO member states have T&CM policies, scant research has focused on these policies and their public health implications. This paper defines a novel term "therapeutic pluralism," and it aims at characterizing related policies in Latin America.Methods: A qualitative content analysis of Latin American therapeutic pluralism policies was performed. Policies' characteristics and the reported social, political, and economic forces that have made possible their development were assessed. Pre-defined policy features were categorized on an MS-Excel; in-depth text analyses were conducted in NVivo. Analyses followed the steps described by Bengtsson: decontextualization, recontextualization, categorization, and compilation.Results: Seventy-four (74) policy documents from 16 of the 20 sovereign Latin American countries were included. Mechanisms for policy enactment included: Constitution, National Law, National Policy, National Healthcare Model, National Program Guideline, Specific Regulatory Norms, and Supporting Legislation, Policies, and Norms. We propose a four-category typology of policy approaches in Latin America: Health Services-centered, Model of Care-based, Participatory, and Indigenous People-focused. Common themes countries used when justifying developing these policies included: benefits to the health system, legal and political mandates, supply and demand, and culture and identity. Social forces these policies referenced as influencing their development included: pluralism, self-determination and autonomy, anticapitalism and decolonization, safeguarding cultural identity, bridging cultural barriers, and sustainability.Conclusion: Policy approaches to therapeutic pluralism in Latin America go beyond integrating non-biomedical interventions into health services; they offer perspectives for transforming health systems. Characterizing these approaches has implications for policy development, implementation, evaluation, international collaboration, the development of technical cooperation tools and frameworks, and research.
Purpose: Primary care physicians (PCPs) often face a complex intersection of patient expectations, evidence, and policy that influences their care recommendations for acute low back pain (aLBP). The purpose of this study was to elucidate patterns of PCP orders for patients with aLBP, identify the most common patterns, and describe patient clinical and demographic characteristics associated with patterns of aLBP care.Methods: This prospective cohort study included 9574 aLBP patients presenting to 1 of 77 primary care practices in 4 geographic locations in the United States. We performed a cluster analysis of PCP orders extracted from electronic health records within the first 21 days of an initial visit for aLBP.Results: 1401 (15%) patients did not receive a PCP order related to back pain within the first 21 days of their initial visit. These patients predominantly had aLBP without leg pain, less back-related disability, and were at low-risk for persistent disability. Of the remaining 8146 patients, we found 4 distinct order patterns: combined nonpharmacologic and first-line medication (44%); secondline medication (39%); imaging (10%); and specialty referral (7%). Among all patients, 29% received solely 1 order from their PCP. PCPs more often combined different guideline concordant and discordant orders. Patients with higher selfreported disability and psychological distress were more likely to receive guideline discordant care.Conclusion: Guideline discordant orders such as steroids and NSAIDS are often combined with guideline recommended orders such as physical therapy. Further defining patient, clinician, and health care setting characteristics associated with discordant care would inform targeted efforts for deimple-mentation initiatives. ( J Am Board Fam Med 2023;36:986-995.)
Population Medicine considers the following types of articles:• Research Papers -reports of data from original research or secondary dataset analyses.• Review Papers -comprehensive, authoritative, reviews within the journal's scope.These include both systematic reviews and narrative reviews.• Short Reports -brief reports of data from original research.• Policy Case Studies -brief articles on policy development at a regional or national level.• Study Protocols -articles describing a research protocol of a study.• Methodology Papers -papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.• Methodology Papers -papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.