IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Yoga
Other interventionEach 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 1-2 yoga instructors and no more than 5 participants per yoga instructor (up to 10 participants/group).
Physical Therapy
Other interventionThe 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). Participants will receive a guidebook for guiding and recording home practice, based on Saper's guidebook and modified based on feedback from experts and stakeholders for clarity and cultural appropriateness.
Treatment As Usual
Other interventionParticipants 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 patients who receive on-site medical care have the opportunity to address nonpharmacological and pharmacological treatment with onsite physicians and physician assistants, and to receive referral to specialty care including physical therapy and orthopedics at multiple Montefiore locations throughout the Bronx.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: YogaExperimental treatment 1 intervention
Group B: Physical TherapyExperimental treatment 1 intervention
Group C: Treatment As UsualOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity
Change in Pain Intensity on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain intensity subscale. The BPI pain intensity subscale consists of 4 items which asks patients to rate their worst pain, least pain, average pain, and current pain using a 0-10 numeric rating scale (NRS), where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine" such that higher scores are associated with greater pain intensity. Scores from the four items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.
Time frame
From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months2
Illicit opioid use
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids \[unprescribed\]. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 monthsSecondary outcomes
1
Change in Pain Interference - Brief Pain Inventory (BPI)
Change in Pain interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associated with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.
Time frame
From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months2
Heroin Use
Heroin use will be defined by self-reported heroin use days over the past 30 days using an item from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months3
Fentanyl Use
Fentanyl use will be defined by self-reported, unprescribed, fentanyl use days over the past 30 days using an item from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months4
Unprescribed Prescription Opioid Analgesic Use
Unprescribed prescription opioid analgesic use will be defined by self-reported number of days of prescription opioid analgesic use that is not prescribed, over the past 30 days, using items from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Albert Einstein College of Medicine
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Weill Medical College of Cornell University
Collaborator
Wake Forest University
Collaborator
Source ClinicalTrials.gov