IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yoga, Physical Therapy, Treatment As Usual.
- Who it may be relevant to
- Registry conditions: Substance Use Disorders, Chronic Pain, Opioid Use Disorder, Back Pain Lower Back Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder
Overview
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 180 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.
Interventions
- Other Yoga
Each yoga class will follow a standardized structure, allowing participants to easily re-join if they miss classes. Yoga classes will be adapted to the abilities and limitations of each study participant, for example, using a chair for sitting exercises rather than the floor and to assist with balance. Postures (asanas) will target back pain and include mindfulness, relaxation, and breathing practices integral to hatha yoga, with focus on breath-based movement throughout. Each group will have 1- - Other Physical Therapy
The assessment at the second screening visit by the Physical Medicine \& Rehabilitation physician/Physical Therapy staff will be available to physical therapists in the Electronic Health Record and will guide the type of exercises, to focus on stabilization (strengthening core trunk muscles) and flexion or extension exercises. Sessions are divided into 30 minutes of working directly with a physical therapist and 30 minutes of supervised aerobic exercise (on treadmill or recumbent bike). Particip - Other Treatment As Usual
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. Those patien
Primary outcome measures
- Change in Pain Intensity [Time frame: From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months]
- Illicit opioid use [Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months]
Secondary outcome measures (12)
- Change in Pain Interference - Brief Pain Inventory (BPI) [Time frame: From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months]
- Heroin Use [Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months]
- Fentanyl Use [Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months]
- Unprescribed Prescription Opioid Analgesic Use [Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months]
- Health-related quality of life (HRQoL) [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months]
- Pain Catastrophizing [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months]
- Opioid Craving [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months]
- Physical Activity - International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months]
- Global Impression of Change [Time frame: 1 month, 2 months, 3 months, and 9 months]
- Depressive Symptoms [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months]
- Anxiety Symptoms [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months]
- Positive urine test for non-prescribed opioids [Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months]
Eligibility criteria
Inclusion criteria
- age ≥18 years old
- English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
- receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
- 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)
- Willingness to participate in all study components
- ability to provide informed consent, assessed using consent teach-back
Exclusion criteria
- severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study)
- acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
- cancer pain related to malignancy
- yoga practice or PT in the prior 60 days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Montefiore DoSA Wellness Centers — The Bronx
Identifiers
NCT: NCT05492825 · 2021-13320 · RM1DA055437