Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder

Summary

This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Yoga

  Each yoga class will follow a standardized structure, allowing participants to easily re-join if they miss classes. Yoga classes will be adapted to the abilities and limitations of each study participant, for example, using a chair for sitting exercises rather than the floor and to assist with balance. Postures (asanas) will target back pain and include mindfulness, relaxation, and breathing practices integral to hatha yoga, with focus on breath-based movement throughout. Each group will have 1-2 yoga instructors and no more than 5 participants per yoga instructor (up to 10 participants/group).

• Other
  Physical Therapy

  The assessment at the second screening visit by the Physical Medicine \& Rehabilitation physician/Physical Therapy staff will be available to physical therapists in the Electronic Health Record and will guide the type of exercises, to focus on stabilization (strengthening core trunk muscles) and flexion or extension exercises. Sessions are divided into 30 minutes of working directly with a physical therapist and 30 minutes of supervised aerobic exercise (on treadmill or recumbent bike). Participants will receive a guidebook for guiding and recording home practice, based on Saper's guidebook and modified based on feedback from experts and stakeholders for clarity and cultural appropriateness.

• Other
  Treatment As Usual

  Participants in the Treatment As Usual group will receive routine clinical care. This includes: 1) pain assessment using a 10-point scale, at OTP admission and annual physical exams. This is documented on a templated form in the OTP electronic health record, as well as whether pain is acute vs chronic pain, and a treatment plan (e.g., on-site care, outside primary care clinician, pain management referral). 2) clinical treatment of pain by participants' on-site or outside clinicians. Those patients who receive on-site medical care have the opportunity to address nonpharmacological and pharmacological treatment with onsite physicians and physician assistants, and to receive referral to specialty care including physical therapy and orthopedics at multiple Montefiore locations throughout the Bronx.

Location