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Yoga + Physical Therapy for Chronic Back Pain and Opioid Addiction

N/A
Recruiting
Led By Joanna Starrels, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must 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)
Age ≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Awards & highlights

Study Summary

This trial will test whether yoga or physical therapy can help people with chronic back pain who are receiving treatment for opioid addiction.

Who is the study for?
This trial is for adults over 18 with chronic back pain who are also receiving treatment for opioid use disorder at Montefiore OTP network. They must have moderate to severe pain and not have changed their medication dose recently. Participants should be able to understand English or Spanish, and haven't done yoga or physical therapy in the last 60 days.Check my eligibility
What is being tested?
The study compares three approaches: yoga classes, physical therapy sessions, both provided onsite at opioid treatment programs, and the usual care without these additions. The goal is to see which method best improves pain management and reduces opioid use over a period of up to nine months.See study design
What are the potential side effects?
Yoga might cause muscle strains or falls if not practiced carefully. Physical therapy could lead to soreness or discomfort as muscles are stretched and strengthened. Usual care has no additional side effects beyond those already associated with standard treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic back pain with a moderate or higher pain level.
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I am 18 years old or older.
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I have been on stable methadone or buprenorphine for OUD treatment for at least 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), 1 month, 2 months, 3 months, 6 months and 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), 1 month, 2 months, 3 months, 6 months and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Health-related quality of life
Illicit opioid use
Pain Intensity
Secondary outcome measures
Cost effectiveness
Pain Catastrophizing
Pain
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: YogaExperimental Treatment1 Intervention
Participants in the yoga group will receive a manualized intervention of 12 weekly, group-based, 60-minute yoga classes, and guided home practice.
Group II: Treatment As UsualExperimental Treatment1 Intervention
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.
Group III: Physical TherapyExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,856,763 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,004 Total Patients Enrolled
Joanna Starrels, MDPrincipal InvestigatorAlbert Einstein College of Medicine

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05492825 — N/A
Opioid Use Disorder Research Study Groups: Treatment As Usual, Physical Therapy, Yoga
Opioid Use Disorder Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT05492825 — N/A
Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492825 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What purpose does this research endeavor intend to fulfill?

"This research trial will be three months in duration and its primary objective is to evaluate Pain Intensity. Other outcomes evaluated include Perceived Stress (utilizing the NIH Toolbox fixed form 18+), Pain Catastrophizing as measured by PCS short-form, and Cost Effectiveness which will be calculated with an Incremental Cost-Effectiveness Ratio associated with yoga/PT vs TAU. To measure effectiveness levels, researchers are utilizing the PROMIS Preference scoring system for evaluating Health Related Quality of Life. Additionally, cost components such as those related to intervention delivery, other healthcare services, participant time costs and labor market earnings must all"

Answered by AI

Are there any vacancies for volunteers in this research study?

"According to clinicaltrials.gov, the recruitment phase of this medical trial has been completed - having initially opened on September 1st 2022 and last edited on August 5th 2022. Although no longer actively seeking participants, there are 1978 other trials currently recruiting patients."

Answered by AI

Who else is applying?

What site did they apply to?
Montefiore DoSA Wellness Centers
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

Because of the constant pain in my body. I have lower back pain and arthritis in my right knee.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Shadi Nahvi 2023. "IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05492825.
~230 spots leftby Nov 2026
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