IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT05492825
Status
Recruiting
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Conditions

  • Back Pain Lower Back Chronic
  • Chronic Pain
  • Opioid Use Disorder
  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Yoga — OTHER
    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).
  • Physical Therapy — OTHER
    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.
  • Treatment As Usual — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 27, 2023
Status verified
Mar 2026
Primary completion
Nov 2, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Yoga
    Participants in the yoga group will receive a manualized intervention of 12 weekly, group-based, 60-minute yoga classes, and guided home practice.
  • Experimental: Physical Therapy
    Participants in the PT group will receive a manualized intervention of 12 weekly, individual, 60-minute PT sessions, with home practice, based on the Saper protocol.
  • 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.

Primary Outcome Measure

Change in Pain Intensity [ Time Frame: From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore DoSA Wellness CentersThe BronxNew York10454
Shadi Nahvi, MD
[email protected]
718-920-5379

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By research site
Montefiore DoSA Wellness Centers· The Bronx, NY

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