RECRUITING

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

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Conditions

Substance Use DisordersChronic PainOpioid Use DisorderBack Pain Lower Back Chronic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-02-27
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05492825

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age ≥18 years old
  2. 2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
  3. 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. 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. 5. Willingness to participate in all study components
  6. 6. ability to provide informed consent
  1. 1. severe disabling conditions that could make participation in yoga or PT hazardous
  2. 2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
  3. 3. CP related to malignancy
  4. 4. yoga practice or PT in the prior 60 days

Contacts and Locations

Study Contact

Shadi Nahvi, MD
CONTACT
718-920-5379
SNAHVI@montefiore.org
Beth Hribar, MPP
CONTACT
608-335-3481
mary.hribar@einsteinmed.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27
Study Completion Date2027-02

Study Record Updates

Study Start Date2023-02-27
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

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