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

NCT05492825 | Recruiting DMC

• 2 other identifiers: 2021-13320RM1DA055437
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Substance Use Disorders; Chronic Pain; Opioid Use Disorder; Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity

  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.

  From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months

• Illicit opioid use

  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.

  Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months

Secondary Outcomes (20)

• Change in Pain Interference - Brief Pain Inventory (BPI)

  From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months

• Heroin Use

  Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months

• Fentanyl Use

  Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months

• Unprescribed Prescription Opioid Analgesic Use

  Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months

• Health-related quality of life (HRQoL)

  Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months

Study Arms (3)

Yoga

EXPERIMENTAL

Participants in the yoga group will receive a manualized intervention of 12 weekly, group-based, 60-minute yoga classes, and guided home practice.

Other: Yoga

Physical Therapy

EXPERIMENTAL

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: Physical Therapy

Treatment As Usual

OTHER

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.

Other: Treatment As Usual

Interventions

Yoga OTHER

Each yoga class will follow a standardized structure, allowing participants to easily re-join if they miss classes. Yoga classes will be adapted to the abilities and limitations of each study participant, for example, using a chair for sitting exercises rather than the floor and to assist with balance. Postures (asanas) will target back pain and include mindfulness, relaxation, and breathing practices integral to hatha yoga, with focus on breath-based movement throughout. Each group will have 1-2 yoga instructors and no more than 5 participants per yoga instructor (up to 10 participants/group).

Yoga

Physical Therapy OTHER

The assessment at the second screening visit by the Physical Medicine \& Rehabilitation physician/Physical Therapy staff will be available to physical therapists in the Electronic Health Record and will guide the type of exercises, to focus on stabilization (strengthening core trunk muscles) and flexion or extension exercises. Sessions are divided into 30 minutes of working directly with a physical therapist and 30 minutes of supervised aerobic exercise (on treadmill or recumbent bike). Participants will receive a guidebook for guiding and recording home practice, based on Saper's guidebook and modified based on feedback from experts and stakeholders for clarity and cultural appropriateness.

Physical Therapy

Treatment As Usual OTHER

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. Those patients who receive on-site medical care have the opportunity to address nonpharmacological and pharmacological treatment with onsite physicians and physician assistants, and to receive referral to specialty care including physical therapy and orthopedics at multiple Montefiore locations throughout the Bronx.

Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, assessed using consent teach-back

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Weill Medical College of Cornell University: collaborator
• Wake Forest University: collaborator

Study Sites (1)

Montefiore DoSA Wellness Centers

The Bronx, New York, 10454, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Chronic Pain; Opioid-Related Disorders

Interventions

Yoga; Physical Therapy Modalities; Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques; Rehabilitation

Study Officials

• Joanna Starrels, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Shadi Nahvi, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shadi Nahvi, MD

CONTACT

718-920-5379; SNAHVI@montefiore.org

Beth Hribar, MPP

CONTACT

608-335-3481; mary.hribar@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1:1

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: August 9, 2022
• Study Start: February 27, 2023
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)