Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I
Completed · Not applicable
Conditions studied: Opioid Use, Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT04646148
- Run by
- Butler Hospital
- People needed
- 20
- Starts
- 2021-03-01
- Expected to finish
- 2021-11-01
- Last updated by the study team
- 2022-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
- CODAC Behavioral Healthcare — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.