N/A
N=20
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I
Opioid Use · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04646148 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants Recruited — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Yoga classes (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Recruited |
20 | — |
| PRIMARY Number of Yoga Teachers Trained to > 80% Fidelity to the Manual |
4 | — |
| PRIMARY Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected |
100; 100; 8.3; 62.5; 100; 58.3 | — |
Summary
Phase 1 - MOST Preparation Phase:
1. To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.
2. Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
3. Demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.
Eligibility Criteria
Inclusion Criteria
- Enrolled in methadone maintenance (MMT) or buprenorphine/naloxone (BUP) treatment for > 3 months
- Plan to continue treatment for next 6 months
- Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
- Aged > 18
- Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences
- Available at least one of the times study classes are offered.
Exclusion Criteria
- Currently taking yoga classes or practicing yoga at home once per week or more often.
- Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
- Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
- Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
- Surgery requiring overnight hospitalization planned in the next 3 months
- Pregnancy
- Plan to move out of the area within 6 months.
- Homeless, defined as any time in the past month sleeping in a shelter or on the street.
Data sourced from ClinicalTrials.gov (NCT04646148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.