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New treatment option for Substance Use Disorders
Official title IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
ClinicalTrials.gov ID: NCT05492825
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture...
- acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active...
- cancer pain related to malignancy
- yoga practice or PT in the prior 60 days
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.