Actively Recruiting
Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder
Led by Albert Einstein College of Medicine · Updated on 2026-03-31
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating yoga and physical therapy as onsite treatments at opioid treatment programs (OTPs) for individuals with opioid use disorder (OUD) who also suffer from chronic back pain. This trial aims to test whether these movement and mindfulness therapies can improve pain intensity, opioid use, and quality of life in this population. The study is a pragmatic, open-label, randomized controlled trial enrolling 345 participants with moderate to severe chronic back pain receiving treatment for OUD. Participants are randomly assigned to one of three groups: weekly group yoga classes, weekly individual physical therapy (PT) sessions, or treatment as usual (TAU) at their OTP. Yoga classes include breathing, mindfulness, and targeted postures for back pain, adapted to participant abilities. PT sessions focus on strengthening core muscles and aerobic exercise with a home practice guidebook. The TAU group receives routine clinical care, including pain assessments and possible referrals for pain management. Participants attend research visits for screening, baseline, and follow-ups at months 1, 2, 3, 6, and 9. Assessments include pain intensity, opioid use and craving, quality of life, physical function, mood, anxiety, and other health measures. Researchers will also evaluate therapy attendance, retention in medications for OUD, and factors affecting implementation of the interventions. Safety and adherence are monitored throughout the study period lasting over nine months.
CONDITIONS
Brief Title
IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to speak and participate in English or Spanish
- Receiving methadone or buprenorphine treatment for opioid use disorder at the Montefiore opioid treatment program network for at least 12 weeks with no dose change in the last 14 days
- Chronic low or mid back pain with moderate or greater pain severity (score of 4 or higher on the Pain, Enjoyment of Life and General Activity Scale)
- Willingness to participate in all study components
- Ability to provide informed consent, confirmed by consent teach-back
You will not qualify if you...
- Severe disabling conditions that make yoga or physical therapy unsafe, such as spinal canal stenosis, severe scoliosis, recent spine or joint surgery, severe neurological or cardiovascular disease requiring recent hospitalization, inability to stand for 60 seconds, regular use of wheelchair or walker with inability to walk at least 4 steps, or multiple falls in the prior year
- Acute psychiatric conditions preventing participation, including acute mania, active suicidality or homicidality, or psychosis
- Cancer pain related to malignancy
- Yoga practice or physical therapy received in the prior 60 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 screening visits including physical therapy assessment
Duration - 12 weeks
Participants receive one of three interventions: 12 weekly group-based yoga classes with guided home practice, 12 weekly individual physical therapy sessions with home practice, or routine clinical care for pain management.
Weekly visits for up to 12 weeks
Duration - Up to 9 months from baseline
Participants complete assessments to monitor changes in pain intensity, opioid use, quality of life, and other health outcomes up to 9 months after starting treatment.
Assessments at 1, 2, 3, 6, and 9 months
Trial Site Locations
Total: 1 location
1
Montefiore DoSA Wellness Centers
The Bronx, New York, United States, 10454
Actively Recruiting
Research Team
S
Shadi Nahvi, MD
B
Beth Hribar, MPP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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