Clinical trial NCT05492825: IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Official title: Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Chronic Pain
Opioid Use Disorder
Back Pain Lower Back Chronic
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-08-09
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1
Primary purpose: TREATMENT

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 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.

Detailed description: This clinical trial will test yoga and physical therapy (PT) for individuals with concurrent opioid use disorder (OUD) and chronic pain (CP), onsite at community-based opioid treatment programs (OTPs). The investigators will focus on those who suffer from back pain, as it is the leading cause of CP among patients with OUD and will recruit individuals who are enrolled in treatment at OTPs in our health system in the Bronx, NY. Lack of integrated treatments addressing both OUD and CP has resulted in failed efforts to control the overdose epidemic. This project addresses this need by proposing to test on-site yoga and PT at OTPs.

The research team's proposed model is that CP from back pain among individuals with OUD leads to decreased physical function, decreased mood and anxiety symptoms, and increased opioid craving. To break this vicious cycle, the investigators propose to target both physical function (via PT or yoga) and mindfulness (via yoga).

Targeting physical function: Both yoga and PT are movement therapies which increase strength and flexibility, improving physical function and pain. Some movement therapies (e.g., exercise) have decreased substance use in individuals with alcohol and tobacco use disorders, but this is understudied in OUD.

Targeting mindfulness: As a mind-body approach, yoga advances overall well-being through practices of mindful breathing and mindfulness meditation. Improving mindfulness may reduce mood and anxiety symptoms, pain catastrophizing, pain intensity and interference, opioid craving and opioid use.

The investigators will test the overall hypothesis that yoga and PT provided onsite at OTPs will improve pain, opioid use, and quality of life among people with OUD and chronic back pain and will be cost effective. The investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open label, three-arm (1:1:1) randomized controlled trial of: a) onsite yoga at OTPs, b) onsite PT at OTPs, and c) treatment as usual (TAU). The investigators will enroll 345 participants (115/115/115) with chronic, moderate or severe back pain in a 12-week intervention. Comprehensive assessments will be done at study enrollment and at months 1, 2, 3, 6, and 9. The investigators will assess pain intensity (primary outcome), pain interference, opioid use and craving, and quality of life.

Aim 1. To test the effectiveness of onsite yoga at OTPs in patients with OUD and CP at 6 months follow-up. H1a: Compared to TAU, on-site yoga will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H1b: Therapeutic improvement in H1a will be mediated by physical function and mindfulness.

Aim 2. To test the effectiveness of onsite PT at OTPs in patients with OUD and CP at 6 months follow-up. H2a: Compared to TAU, onsite PT will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H2b: Therapeutic improvement in H2a will be mediated by physical function.

Aim 3. To inform future implementation and dissemination efforts: 3a) Examine factors influencing Reach, Adoption, Implementation, and Maintenance (RE-AIM outcomes) of onsite yoga and PT at OTPs. The investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains, including qualitative interviews with 30 participants and 10 OTP stakeholders.

Exploratory Aim. The investigators will also explore the effectiveness of yoga compared to PT on outcomes and will examine complex patterns of predictors of pain and OUD outcomes with respect to each intervention, including alcohol and cannabis use, mood and anxiety symptoms, comorbidities, and social determinants of health.

Eligibility criteria: Inclusion Criteria:

1. age ≥18 years old
2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
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. 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. Willingness to participate in all study components
6. ability to provide informed consent

Exclusion Criteria:

1. severe disabling conditions that could make participation in yoga or PT hazardous
2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
3. CP related to malignancy
4. yoga practice or PT in the prior 60 days

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 months
measure: Illicit opioid use
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Secondary outcomes:
measure: Pain Interference
timeFrame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
measure: Pain Catastrophizing
timeFrame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
measure: Perceived stress
timeFrame: Baseline (Week 0), 3 months, 6 months and 9 months
measure: Cost effectiveness
timeFrame: 9 month intervention period
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore DoSA Wellness Centers
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Joanna Starrels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Shadi Nahvi, MD
role: PRINCIPAL_INVESTIGATOR
References: