Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
CompletedNot applicableNCT04641221
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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 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: 1. To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above. 2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. 3. Examine mechanisms by which components are hypothesized to work.
Study details
- Official title
- Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
- Conditions
- Interventions
- Behavioral: Weekly Yoga Classes
- Sponsor
- Butler Hospital
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2022-02-20
- Primary completion
- 2024-11-15
- 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 MMT or 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 * No access to a reasonably safe, reliable place to engage in personal yoga practice and a private space to participate in online yoga classes
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04641221