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.

"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.

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.

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.

Developing and employing a 'responsive manualization' in the 'Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment' comparative effectiveness study.

OBJECTIVE: The aim of this article is to describe the process used to develop an acupuncture therapy manual for a large effectiveness trial comparing individual care against group care for chronic pain in an underserved population. The design needed to not only ensure research consistency and replicability but also be 'responsive' to real world heterogeneous and evolving presentations in challenging physical settings. BACKGROUND: Chronic pain is prevalent in the United States. While acupuncture is effective for chronic pain, minority, ethnically diverse and lower socioeconomic populations have limited access. Group acupuncture is proposed as a lower cost option to facilitate access in safety net settings, but research on the effectiveness of group versus individual acupuncture is lacking. METHODS: We engaged a modified Delphi process with expert practitioners from diverse backgrounds who were experienced in individual and group practice. All contributions were recorded and collated for second- and third-round consensus discussions that included contributions by the trial's research acupuncturists. RESULTS: A 'responsive manual' flow chart was created with suggested sequencing that included interviews concurrent with palpation, Tui na, Gua sha, acupuncture needling, ear treatment, basic recommendations and options for departure with rationale. The manual was implemented by six research acupuncturists in five primary care settings in the Bronx, New York, with weekly team meetings to discuss manual use. There were no serious adverse events (AE) and few minor AE reported in this trial. CONCLUSION: A 'responsive manual' can be structured and implemented that is not only consistent and replicable but also flexible to accommodate the real-world clinical needs of practitioners and patients in challenging physical settings.