RECRUITING

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

Description

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 345 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.

Conditions

Substance Use DisordersChronic PainOpioid Use DisorderBack Pain Lower Back Chronic
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Related Conditions:

Substance Use DisordersChronic PainOpioid Use DisorderBack Pain Lower Back Chronic

Study Overview

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Study Details

Study overview

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 345 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.

Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder

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

Condition
Substance Use Disorders
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore DoSA Wellness Centers, Bronx, New York, United States, 10454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. age ≥18 years old
  • 2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
  • 3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
  • 4. 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
  • 5. Willingness to participate in all study components
  • 6. ability to provide informed consent
  • 1. severe disabling conditions that could make participation in yoga or PT hazardous
  • 2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
  • 3. CP related to malignancy
  • 4. yoga practice or PT in the prior 60 days

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Albert Einstein College of Medicine,

Joanna Starrels, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine

Shadi Nahvi, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine

Study Record Dates

2027-02