Yoga and Physical Therapy for Chronic Pain and Opioid Use Disorder Onsite in an Opioid Treatment Program: A Randomized Controlled Trial.

BACKGROUND: There is a lack of integrated treatment for chronic pain and opioid use disorder (OUD). Yoga and physical therapy (PT) may improve pain and physical function of people living with (PLW) chronic low back pain (CLBP) and may also reduce opioid craving and use, but PLW with OUD face barriers to accessing these interventions. We hypothesize that compared to treatment as usual (TAU), providing yoga and PT onsite at opioid treatment programs (OTPs) will be effective at improving pain, opioid use, and quality of life among people with CLBP and OUD, and will be cost-effective. METHODS: In this hybrid type-1 effectiveness-implementation study, we will randomly assign 345 PLW CLBP and OUD from OTPs in the Bronx, NY, to 12 weeks of onsite yoga, onsite PT, or TAU. Primary outcomes are pain intensity, opioid use, and cost-effectiveness. Secondary outcomes include physical function and overall well-being. DISCUSSION: This trial tests an innovative, patient-centered approach to combined management for pain and OUD in real-world settings. We rigorously examine the efficacy of yoga and PT onsite at OTPs as nonpharmacologic, cost-effective treatments among people with CLBP and OUD who face barriers to integrated care.

Feasibility and Acceptability of Yoga for Adolescents with Juvenile Idiopathic Arthritis.

BACKGROUND/OBJECTIVES: Yoga is effective for adults with arthritis but unstudied in adolescents with juvenile idiopathic arthritis (JIA). METHODS: A pilot study assessed the feasibility and acceptability of an 8-week group yoga intervention for adolescents ages 14-18 with JIA. Each 75-min session included breathing techniques, relaxation, mindfulness, and modified yoga postures, using yoga props and a rope wall. An online video was available for home practice. The outcome measures administered at the baseline and at 8 weeks were physician global assessment with joint count, visual assessment with a joint damage assessment index, the Pediatric Quality of Life Arthritis Module 3.0 (Peds QL), and the visual analog scale for pain. RESULTS: Thirteen out of 25 participants attended ≥1 class with a mean of 5.7 ± 2.2 classes. Common reasons for non-enrollment included distance, schedule, and lack of interest. The average distance to classes was 29.0 ± 41.7 miles. There was a trend toward improvement for joint count (p = 0.07), global assessment (p = 0.10), and the Pain and Hurt domain of the Peds QL (p = 0.13), but no other outcomes approached significance. Satisfaction data from an anonymous survey (n = 8) were high in all areas. CONCLUSIONS: Adolescents with JIA who attended yoga reported enjoyment, pain reduction, and interest in continued practice with no adverse events. Future studies should consider stakeholder engagement to reduce barriers and larger sample sizes to test the effectiveness.

Development and Implementation of a Flexible Yoga Therapy Protocol in the Group Acupuncture Therapy and Modified Yoga (GAPYOGA) Pilot Study.

Chronic pain is the most common reason U.S. adults seek medical care. Acupuncture and yoga show effectiveness, and a recent study assessed the feasibility of these two modalities for chronic pain at federally qualified health centers. Yoga research is rarely individualized, which is important for chronic pain treatments. Six experienced yoga professionals drew on research and clinical experience to co-create a yoga therapy protocol standardized for replication with flexibility for individual care. Yoga therapy was to be combined with a previously developed flexible acupuncture intervention in a feasibility trial. Categories of practices were identified as relevant and appropriate for chronic pain management in a federally qualified health center. Within each category, specific practices were listed for each provider to select as appropriate. These were based on usefulness for chronic pain, safety, ease of teaching/learning, and cultural appropriateness. The final manual included: (1) stabilizing poses, (2) mobilizing poses, (3) breathing practices, (4) relaxation, (5) mental practices, and (6) applied philosophy. Each participant began with an intake to inform practice selection. Ten subsequent sessions were 30 minutes each, with 1-2 participants receiving simultaneous care. First sessions included diaphragmatic breathing and some physical postures. All practices were adapted. Over 10 sessions, at least one practice from each category was included. Participants were given instructions/images for home practice. Individual charting ensured continuity of care and consistency across sessions. In evidence-informed practice, there exists a tension between replicability and individualization. A flexible protocol allows both. Future application in research and clinical settings will help to determine feasibility and effectiveness.

Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Settings for an Underserved Population: A Feasibility Pilot Study.

Background: Acupuncture and yoga have both been shown to be effective in chronic pain. Underrepresented populations have poorer pain outcomes with less access to effective pain care. Objective: To assess the feasibility of bundling group acupuncture with yoga therapy for chronic neck, back or osteoarthritis pain in safety net settings. Methods: This was a feasibility pilot in Bronx and Harlem primary care community health centers. Participants with chronic neck, back or osteoarthritis pain received acupuncture and yoga therapy over a 10-week period. Participants received 10 weekly acupuncture treatments in group setting; with Yoga therapy sessions beginning immediately following the 3rd session. Primary outcome was pain interference and pain intensity on the Brief Pain Inventory (BPI); Outcomes were measured at baseline, 10-week close of intervention, and 24-week follow-up. Results: 93 patients were determined to be eligible and completed the baseline interview. The majority of participants were non-White and Medicaid recipients. 78 (84%) completed the intervention and 10-week survey, and 58 (62%) completed the 24-week post intervention survey. Participants received an average number of 6.5 acupuncture sessions (out of a possible 10), and 4 yoga sessions (out of a possible 8) over the 10-week intervention. Patients showed statistically significant improvements in pain at the close of the intervention and at a somewhat lesser rate, at 24-weeks post intervention. Challenges included telephone outreach and site coordination integrating acupuncture with yoga therapy. The trial also had to be stopped early due to the COVID-19 pandemic. Conclusions: Bundling acupuncture therapy and yoga therapy is feasible for an underrepresented population with chronic pain in urban community health centers with preliminary indications of acceptability and benefit to participants.

Identifying and addressing patient substance use: a survey of chiropractic clinicians.

BACKGROUND: Chiropractors commonly encounter patients who present for spine pain with parallel substance use. There is currently no widespread training within the chiropractic profession to prepare chiropractors to recognize and address substance use in clinical practice. The purpose of this study was to examine chiropractors' confidence, self-perceptions, and interest in education associated with identifying and addressing patient substance use. METHODS: A 10-item survey was developed by the authors. The survey addressed chiropractors' assessment of their training, experiences, and educational interest/needs regarding identifying and addressing patient substance use. The survey instrument was uploaded to Qualtrics and was electronically distributed to chiropractic clinicians at active and accredited English-speaking Doctor of Chiropractic degree programs (DCPs) in the United States. RESULTS: A total of 175 individual survey responses were returned from a total of 276 eligible participants (63.4% response rate) from 16 out of 18 active and accredited English-speaking DCPs (88.8% of DCPs) in the United States. Nearly half of respondents strongly disagreed or disagreed (n = 77, 44.0%) that they were confident in their ability to identify patients who misuse prescription medication. The majority of respondents (n = 122, 69.7%) indicated that they did not have an established referral relationship with local clinical providers who provide treatment for individuals who use drugs or misuse alcohol or prescription medications. Most respondents strongly agreed or agreed (n = 157, 89.7%) that they would benefit from participating in a continuing education course on topics related to patients who use drugs or misuse alcohol or prescription medications. CONCLUSIONS: Chiropractors indicated a need for training to help them identify and address patient substance use. There is a demand among chiropractors to develop clinical care pathways for chiropractic referrals and collaboration with health care professionals who provide treatment for individuals who use drugs or misuse alcohol or prescription medications.

A Randomised Controlled Trial of YOGa and Strengthening Exercise for Knee OsteoArthritis: Protocol for a Comparative Effectiveness Trial (YOGA Trial).

Osteoarthritis (OA) is a common joint disorder for which there is no cure. Current treatments are suboptimal. Exercise is a core treatment for knee OA, with muscle strengthening exercise commonly recommended. Yoga is a mind-body exercise intervention that can improve flexibility, muscle strength, balance, and fitness and potentially reduce symptoms of OA. However, there is a scarcity of robust, high-quality conclusive evidence on the efficacy of yoga in knee OA. We are currently conducting the first randomised comparative effectiveness and cost-effectiveness trial of a yoga program compared with a strengthening exercise program in patients with symptomatic knee OA. This study protocol describes the design and conduct of this trial. The YOGA study is a phase III, single-centre, parallel, superiority, randomised, active-controlled trial which will be conducted in Hobart, Australia. One hundred and twenty-six participants (63 in each arm) aged over 40 years with symptomatic knee OA will be recruited from the community and randomly allocated to receive either a 24-week yoga program (3×/week) or a strengthening exercise program (3×/week). The primary outcome will be change in knee pain over 12 weeks, assessed using a 100 mm visual analogue scale (VAS). The secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life, gait speed, biomarkers, and others over 12 and 24 weeks. We will also assess whether the presence of neuropathic pain moderates the effects of yoga compared to strengthening exercise. Additional data, such as cost and resource utilization, will be collected for the cost-effectiveness analysis. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored throughout the study. Once completed, this trial will contribute to the knowledge of whether yoga can be used as a simple, effective, low-cost option for the management of knee OA, thus saving economic costs in the healthcare system.

"The Pain Left, I Was Off and Running": A Qualitative Analysis of Group Acupuncture and Yoga Therapy for Chronic Pain in a Low-Income and Ethnically Diverse Population.

Introduction: Chronic pain and the current opioid epidemic are pressing public health concerns, especially in low-income and ethnically diverse communities. Nonpharmacologic therapies that are safe, effective, and acceptable for the treatment of chronic pain conditions may provide a solution for addressing this issue. This qualitative analysis explores the experience of study participants who received combined acupuncture and yoga therapy (YT) to treat chronic pain delivered in a primary care setting. Methods: The group acupuncture with yoga therapy for chronic neck, low back, and osteoarthritic pain trial (GAPYOGA) assessed the feasibility and effectiveness of group acupuncture (GA) combined with YT in a low-income, racial, and ethnically diverse population. Individual in-depth interviews were conducted with a subset of patients in the trial. Nineteen participants were interviewed for qualitative analysis of their experience. Using the immersion and crystallization method, transcribed interviews were analyzed for themes meaningfully representing participant experience. Results: The combined GA and YT resulted in significant pain relief and transformative healing experiences. Three themes emerged from participant narratives: (1) transformative engagement with self in the healing process through pain relief, psychological well-being, and self-efficacy; (2) therapeutic relationship with acupuncture and yoga providers; and (3) fostering relationships with fellow participants in the group. Discussion: In this study of a low-income and ethnically diverse population, the combination of acupuncture and YT was found to alleviate pain, improve function, promote psychological well-being, and engage participants in self-care practices in a transformative healing process-resulting in physical and psychological benefits.

Development of the CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) guidelines: a Delphi study.

BACKGROUND: The use of yoga as a therapeutic modality is increasing; however, a lack of transparent intervention reporting is restricting the dissemination and implementation of yoga research into clinical and community practice. The aim of this study was to develop a yoga-specific reporting guideline as an extension to existing reporting guidelines for randomised controlled trials, observational studies and case reports. METHODS: Recognised international stakeholders in the design and conduct of yoga research were invited to contribute to the electronic Delphi survey. A four-round Delphi was conducted, whereby panellists rated selected items for their importance in the inclusion of yoga reporting guidelines, according to a 5-step Likert scale. A priori consensus for item inclusion was agreement of items as 'Very important' or 'Extremely important' by ≥80% of panellists. Non-consensus items were forwarded to subsequent rounds for re-rating. RESULTS: 53 experts in yoga research from 11 countries, primarily identifying as researchers (50%), allied health professionals (18.8%) and yoga professionals (12.5%), consented to participate in the Delphi. Of these, 48 completed Round 1 (91%), 43 completed Round 2 (81%), 39 completed Round 3 (74%) and 32 completed Round 4 (60%). Panellists reached consensus for inclusion on 21 items, grouped under 10 domains reflective of more generic intervention-based guidelines. CONCLUSIONS: The consensus-based 21-item CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) checklist provides a minimum reporting template for researchers across a range of methodology designs. Use of these yoga-specific guidelines, in conjunction with the CLARIFY explanation and elaboration guidelines, will standardise the minimum level of detail required for transparent yoga intervention, facilitating the replication, dissemination and implementation of yoga research. Ongoing research will assess the uptake and impact of CLARIFY, to ensure these guidelines retain their relevance to the internationally growing field of yoga research.

CLARIFY 2021: explanation and elaboration of the Delphi-based guidelines for the reporting of yoga research.

BACKGROUND: Reporting of yoga research often lacks the detail required for clinical application, study replication, summary research and comparative effectiveness studies. METHODS: To improve the transparency of reporting yoga interventions, and building on the development of previous reporting guidelines, a group of international yoga research stakeholders developed the consensus-based CheckList stAndardising the Reporting of Interventions For Yoga (CLARIFY) guidelines. RESULTS: The 21-item CLARIFY checklist outlines the minimum details considered necessary for high-quality reporting of yoga research. This paper provides a detailed explanation of each of the 21 items of the CLARIFY checklist, together with model examples of how to integrate each item into publications of yoga research. The CLARIFY guideline serves as an extension for existing research reporting guidelines, and is flexible for use across all study designs. CONCLUSION: We strongly encourage the uptake of these reporting guidelines by researchers and journals, to facilitate improvements in the transparency and utility of yoga research.

Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot.

Objective: To identify factors associated with implementing bundled group acupuncture and yoga therapy (YT) to treat underserved patients with chronic pain in community health center (CHC) settings. This is not an implementation science study, but rather an organized approach for identification of barriers and facilitators to implementing these therapies as a precursor to a future implementation science study. Design: This study was part of a single-arm feasibility trial, which aimed to test the feasibility of bundling GA and YT for chronic pain in CHCs. Treatment outcomes were measured before and after the 10-week intervention period. Implementation feasibility was assessed through weekly research team meetings, weekly yoga provider meetings, monthly acupuncture provider meetings, and weekly provider surveys. Settings: The study was conducted in New York City at two Montefiore Medical Group (MMG) sites in the Bronx, and one Institute for Family Health (IFH) site in Harlem. Subjects: Participants in the feasibility trial were recruited from IFH and MMG sites, and needed to have had lower back, neck, or osteoarthritis pain for >3 months. Implementation stakeholders included the research team, providers of acupuncture and YT, referring providers, and CHC staff. Results: Implementation of these therapies was assessed using the Consolidated Framework for Implementation Research. We identified issues associated with scheduling, treatment fidelity, communication, the three-way disciplinary interaction of acupuncture, yoga, and biomedicine, space adaptation, site-specific logistical and operational requirements, and patient-provider language barriers. Issues varied as to their frequency and resolution difficulty. Conclusions: This feasibility trial identified implementation issues and resolution strategies that could be further explored in future implementation studies. Clinical Trial Registration No.: NCT04296344.

Characteristics of Clients Seeking Yoga Therapy in a University-Based Student Clinic.

Yoga therapy is an emerging profession with recent development of educational competencies, training program accreditation, and practitioner certification. In the United States, most yoga therapy training programs are studio-based and data on mentored clinical encounters are lacking. This study aimed to characterize the client population in a university-based mentored student clinic. As part of a larger feasibility study, data were collected at all clinic visits for 70 consenting clients. Data collected included demographic characteristics, reasons for pursuing care, use of other healthcare approaches, and the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical and mental health. Participants were mostly middle-aged, White, and highly educated. Common reasons for pursuing care were pain and mental health. Most used multiple healthcare approaches. Average scores for most patient-reported outcomes fell within normal range at baseline. Future studies are needed to better characterize yoga therapy users and to expand access for populations in whom the modality is underutilized despite emerging evidence of relevance.

Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Setting for an Underserved Population: Design and Rationale for a Feasibility Pilot.

Chronic pain is prevalent in the United States, with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care, poorer outcomes, and higher risk of fatal opioid overdose. Acupuncture therapy is effective in treating chronic pain conditions including chronic low back pain, neck pain, shoulder pain, and knee pain from osteoarthritis. Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities. Acupuncture therapy also encourages patient engagement and activation. As chronic pain improves, there is a natural progression to want and need to increase activity and movement recovery. Diverse movement approaches are important for improving range of motion, maintaining gains, strengthening, and promoting patient engagement and activation. Yoga therapy is an active therapy with proven benefit in musculoskeletal pain disorders and pain associated disability. The aim of this quasi-experimental pilot feasibility trial is to test the bundling of these 2 effective care options for chronic pain, to inform both the design for a larger randomized pragmatic effectiveness trial as well as implementation strategies across underserved settings.

Yoga for systemic lupus erythematosus (SLE): Clinician experiences and qualitative perspectives from students and yoga instructors living with SLE.

Systemic lupus erythematosus (SLE) is an autoimmune disease associated with widespread inflammation and tissue damage. It is more common and severe among Blacks, Hispanics, and Asians; with higher incidence in women. While the goals of medical treatment are to prevent flares and reduce organ damage, up to 50% of patients perceive their health to be suboptimal with unaddressed needs including fatigue and pain. Recent SLE treatment guidelines focus on improving quality of life. Yoga has shown improvements in quality-of-life and fatigue in various diagnoses. While there is growing evidence that yoga therapy may help osteoarthritis and rheumatoid arthritis symptoms, there is only one reference in the literature related to SLE. METHODS/SETTING: An adjunct study was undertaken to evaluate adapting the Yoga as Self Care for Arthritis in Minority Communities study for a bilingual population living with SLE in the Washington, DC area. Informants included 7 patients enrolled onto the study, and 3 yoga instructors living with SLE. Qualitative methods included journals and semi-structured interviews. RESULTS: Enrolling patients clarified revisions for intake questionnaires, and symptoms that may impact class participation. Participants demonstrated increased balance, body awareness, and tolerated a faster-paced yoga class when compared to those in the parent study. Yoga instructors' recommendations included modifying yoga based on energy levels and frequent changes in physical ability. CONCLUSION: This paper shares perspectives from various informants and affirms the feasibility of progressing to a larger study. It summarizes our findings and recommendations towards creating a randomized controlled trial, as there are currently none in the literature.

Yoga Therapy and Polyvagal Theory: The Convergence of Traditional Wisdom and Contemporary Neuroscience for Self-Regulation and Resilience.

Yoga therapy is a newly emerging, self-regulating complementary and integrative healthcare (CIH) practice. It is growing in its professionalization, recognition and utilization with a demonstrated commitment to setting practice standards, educational and accreditation standards, and promoting research to support its efficacy for various populations and conditions. However, heterogeneity of practice, poor reporting standards, and lack of a broadly accepted understanding of the neurophysiological mechanisms involved in yoga therapy limits the structuring of testable hypotheses and clinical applications. Current proposed frameworks of yoga-based practices focus on the integration of bottom-up neurophysiological and top-down neurocognitive mechanisms. In addition, it has been proposed that phenomenology and first person ethical inquiry can provide a lens through which yoga therapy is viewed as a process that contributes towards eudaimonic well-being in the experience of pain, illness or disability. In this article we build on these frameworks, and propose a model of yoga therapy that converges with Polyvagal Theory (PVT). PVT links the evolution of the autonomic nervous system to the emergence of prosocial behaviors and posits that the neural platforms supporting social behavior are involved in maintaining health, growth and restoration. This explanatory model which connects neurophysiological patterns of autonomic regulation and expression of emotional and social behavior, is increasingly utilized as a framework for understanding human behavior, stress and illness. Specifically, we describe how PVT can be conceptualized as a neurophysiological counterpart to the yogic concept of the gunas, or qualities of nature. Similar to the neural platforms described in PVT, the gunas provide the foundation from which behavioral, emotional and physical attributes emerge. We describe how these two different yet analogous frameworks-one based in neurophysiology and the other in an ancient wisdom tradition-highlight yoga therapy's promotion of physical, mental and social wellbeing for self-regulation and resilience. This parallel between the neural platforms of PVT and the gunas of yoga is instrumental in creating a translational framework for yoga therapy to align with its philosophical foundations. Consequently, yoga therapy can operate as a distinct practice rather than fitting into an outside model for its utilization in research and clinical contexts.

Feasibility and assessment of outcome measures for yoga as self-care for minorities with arthritis: a pilot study.

BACKGROUND: While there is a growing interest in the therapeutic benefits of yoga, minority populations with arthritis tend to be under-represented in the research. Additionally, there is an absence of guidance in the literature regarding the use of multicultural teams and sociocultural health beliefs, when designing yoga studies for a racially diverse population with arthritis. This pilot study examined the feasibility of offering yoga as a self-care modality to an urban, bilingual, minority population with osteoarthritis (OA) or rheumatoid arthritis (RA), in the Washington, DC area. METHODS: The primary objective of the study was to assess the feasibility of offering an 8-week, bilingual yoga intervention adapted for arthritis to a convenience sample of primarily Hispanic and Black/African-American adults. A racially diverse interdisciplinary research team was assembled to design a study to facilitate recruitment and retention. The second objective identified outcome measures to operationalize potential facilitators and barriers to self-care and self-efficacy. The third objective determined the feasibility of using computer-assisted self-interview (CASI) for data collection. RESULTS: Enrolled participants (n = 30) were mostly female (93%), Spanish speaking (69%), and diagnosed with RA (88.5%). Feasibility was evaluated using practicality, acceptability, adaptation, and expansion of an arthritis-adapted yoga intervention, modified for this population. Recruitment (51%) and participation (60%) rates were similar to previous research and clinical experience with the study population. Of those enrolled, 18 started the intervention. For adherence, 12 out of 18 (67%) participants completed the intervention. All (100%), who completed the intervention, continued to practice yoga 3 months after completing the study. Using nonparametric tests, selected outcome measures showed a measurable change post-intervention suggesting appropriate use in future studies. An in-person computerized questionnaire was determined to be a feasible method of data collection. CONCLUSIONS: Findings from this pilot study confirm the feasibility of offering yoga to this racially/ethnically diverse population with arthritis. This article provides recruitment/retention rates, outcome measures with error rates, and data collection recommendations for a previously under-represented population. Suggestions include allocating resources for translation and using a multicultural design to facilitate recruitment and retention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01617421.

Toward an Explanatory Framework for Yoga Therapy Informed by Philosophical and Ethical Perspectives.

Context • Yoga Therapy is an emerging complementary and integrative health practice for which there is increasing interest from both clinical and research perspectives. Currently missing, however, is an explanatory framework for the profession that provides practitioners, clients, and the public with an understanding of how various yogic traditions and principles can be understood in modern health care contexts. Objective • This study proposes an explanatory framework for yoga therapy, informed by phenomenology, eudaimonia, virtue ethics, and first-person ethical inquiry. Conclusions • These 4 philosophical perspectives-phenomenology, eudaimonia, virtue ethics, and first-person ethical inquiry-provide a lens through which to understand how yogic practices support the individual's transformation in the experience of illness, pain, or disability. We propose that this transformation occurs through facilitating a reharmonization of body, mind, and environment toward the experience of eudaimonic well-being.

The importance of research literacy for yoga therapists.

Evidence-Informed Practice (EIP) utilizes the three components of expert opinion, research evidence, and client values. It is a recommended training competency for integrative health practitioners in diverse fields, such as acupuncture and massage therapy. Research Literacy (RL) is a necessary pre-requisite to EIP. Many yoga therapists have limited training in these skills, which negatively impacts inter-professional communication and collaboration, as well as further advancement of yoga therapy research and practice. In this article, we propose inclusion of RL and EIP in the training of yoga therapists. Benefits for client care, collaborative care, and the field of yoga therapy are discussed.