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Yoga + Physical Therapy for Chronic Back Pain and Opioid Addiction

N/A

Recruiting

Led By Shadi Nahvi, 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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), 1 month, 2 months, 3 months, 6 months and 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Health-related quality of life

Illicit opioid use

Pain Intensity

Secondary study objectives

Cost effectiveness

Pain Catastrophizing

Pain

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met