IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Recruiting now · Not applicable
Conditions studied: Substance Use Disorders, Chronic Pain, Opioid Use Disorder, Back Pain Lower Back Chronic
In brief
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 facts
- Study ID
- NCT05492825
- Run by
- Albert Einstein College of Medicine
- People needed
- 180
- Starts
- 2023-02-27
- Expected to finish
- 2026-11-02
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age ≥18 years old
- English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
- receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
- Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)
- Willingness to participate in all study components
- ability to provide informed consent, assessed using consent teach-back
You may not qualify if…
- severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study)
- acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
- cancer pain related to malignancy
- yoga practice or PT in the prior 60 days
Where it is running
- Montefiore DoSA Wellness Centers — The Bronx, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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