Yoga and Physical Therapy for Opioid Use Disorder and Chronic Pain
This study is exploring whether yoga or physical therapy (PT) can help people who have both opioid use disorder (OUD) and chronic back pain. Participants will be randomly assigned to receive either yoga classes, physical therapy, or their usual care. The yoga and PT sessions will take place at opioid treatment programs (OTPs). Researchers want to see if these interventions can reduce pain intensity and illicit opioid use. You may be able to join if you are at least 18 years old, speak English or Spanish, and have been receiving methadone or buprenorphine for OUD at a Montefiore OTP for at least 12 weeks without recent dose changes. The study aims to enroll 180 participants.
- Study design
- This is a randomized controlled trial with 180 participants. Participants will be assigned to one of three groups: yoga, physical therapy, or usual care.
- What's involved
- You would attend research visits at the start, and at 1, 2, 3, 6, and 9 months. If assigned to an intervention group, you would participate in 12 weeks of onsite yoga or physical therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 9 months after the start of the study to measure changes in pain and opioid use.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Joanna Starrels, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
- Shadi Nahvi, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change in Pain IntensityFrom Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months
Change in Pain Intensity on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain intensity subscale. The BPI pain intensity subscale consists of 4 items which asks patients to rate their worst pain, least pain, average pain, and current pain using a 0-10 numeric rating scale (NRS), where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine" such that higher scores are associated with greater pain intensity. Scores from the four items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.
- Illicit opioid useBaseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids \[unprescribed\]. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.