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Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I

CompletedNot applicableNCT04646148
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I
Interventions
  • Behavioral: Yoga classes
Sponsor
Butler Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Start date
2021-03-01
Primary completion
2021-11-01
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04646148