Yoga and physical therapy for patients with opioid use disorder and chronic back pain

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

This study tests whether yoga or physical therapy can help people with opioid use disorder and chronic back pain feel better compared to standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Albert Einstein College of Medicine (other)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT05492825 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of onsite yoga and physical therapy for individuals with opioid use disorder and chronic back pain at community-based opioid treatment programs. Participants will be randomly assigned to receive either yoga, physical therapy, or standard treatment over a 12-week period. The study aims to assess improvements in pain and opioid use outcomes, as well as the implementation of these interventions. By addressing both physical function and mindfulness, the trial seeks to break the cycle of chronic pain and opioid dependence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are receiving methadone or buprenorphine treatment for opioid use disorder and have chronic low or mid back pain.

Not a fit: Patients with severe disabling conditions, acute psychiatric exacerbations, or chronic pain related to malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide integrated treatment options that improve pain management and reduce opioid use for patients with concurrent chronic pain and opioid use disorder.

How similar studies have performed: While movement therapies have shown promise in reducing substance use in other disorders, this specific approach targeting opioid use disorder and chronic pain is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion 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, assessed using consent teach-back

Exclusion Criteria:

1. 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)
2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
3. cancer pain related to malignancy
4. yoga practice or PT in the prior 60 days

Where this trial is running

The Bronx, New York

• Montefiore DoSA Wellness Centers — The Bronx, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Joanna Starrels, MD — Albert Einstein College of Medicine
• Study coordinator: Shadi Nahvi, MD

Conditions: Substance Use Disorders, Chronic Pain, Opioid Use Disorder, Back Pain Lower Back Chronic