IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine
About this trial
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. 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 criteria
Qualifiers
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)
Disqualifiers
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)
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
Trial design
Treatments tested in this trial
- Yoga
- Physical Therapy
- Treatment As Usual
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Albert Einstein College of Medicine
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Weill Medical College of Cornell University
Collaborator
Wake Forest University
Collaborator
Source ClinicalTrials.gov