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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore DoSA Wellness Centers
RECRUITING
The Bronx
Contact Information
Primary
Shadi Nahvi, MD
SNAHVI@montefiore.org
718-920-5379
Backup
Beth Hribar, MPP
mary.hribar@einsteinmed.edu
608-335-3481
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2027-04
Participants
Target number of participants: 345
Treatments
Experimental: Yoga
Participants in the yoga group will receive a manualized intervention of 12 weekly, group-based, 60-minute yoga classes, and guided home practice.
Experimental: Physical Therapy
Participants in the PT group will receive a manualized intervention of 12 weekly, individual, 60-minute PT sessions, with home practice, based on the Saper protocol.
Other: Treatment As Usual
Participants in the Treatment As Usual group will receive routine clinical care. This includes: 1) pain assessment using a 10-point scale, at OTP admission and annual physical exams. This is documented on a templated form in the OTP electronic health record, as well as whether pain is acute vs chronic pain, and a treatment plan (e.g., on-site care, outside primary care clinician, pain management referral). 2) clinical treatment of pain by participants' on-site or outside clinicians.
Related Therapeutic Areas
Chronic Pain
Opioid Use Disorder
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov

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