Physical Therapy for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montefiore DoSA Wellness Centers, Bronx, NY
Chronic Pain+7 More
Physical Therapy - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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, we will evaluate pain and opioid use outcomes and implementation outcomes.

Eligible Conditions

  • Opioid Use Disorder (OUD)
  • Chronic Lower Back Pain (CLBP)
  • Substance Use Disorders (SUD)
  • Chronic Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Baseline (Week 0),1 month, 2 months, 3 months, 6 months and 9 months

3 months
Illicit opioid use
Pain Intensity
9 month intervention perid
Cost effectiveness
Month 9
Perceived stress
Month 9
Health-related quality of life
Pain Catastrophizing
Pain Interference

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Yoga
1 of 2
Physical Therapy
1 of 2
Experimental Treatment

345 Total Participants · 2 Treatment Groups

Primary Treatment: Physical Therapy · No Placebo Group · N/A

Yoga
Other
Experimental Group · 1 Intervention: Yoga · Intervention Types: Other
Physical Therapy
Other
Experimental Group · 1 Intervention: Physical Therapy · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 0),1 month, 2 months, 3 months, 6 months and 9 months
Closest Location: Montefiore DoSA Wellness Centers · Bronx, NY
Photo of Bronx 1Photo of Bronx 2Photo of Bronx 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Chronic Pain
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,134 Total Patients Enrolled
44 Trials studying Chronic Pain
61,297 Patients Enrolled for Chronic Pain
Albert Einstein College of MedicineLead Sponsor
263 Previous Clinical Trials
1,838,382 Total Patients Enrolled
9 Trials studying Chronic Pain
2,026 Patients Enrolled for Chronic Pain
Joanna Starrels, MDPrincipal InvestigatorAlbert Einstein College of Medicine
Shadi Nahvi, MDPrincipal InvestigatorAlbert Einstein College of Medicine

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to communicate in English or Spanish.
You have 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.
You are able to provide informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.