N/A
Completed N=192
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Source: ClinicalTrials.gov NCT04641221 ↗Enrolled (actual)
192
Serious AEs
17.7%
Results posted
Nov 2025
Primary outcomePrimary: Yoga Dosage — 164.5; 99.4; 139.1; 102.2 Total yoga Minutes — p=0.028
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yoga Dosage |
164.5; 99.4; 139.1; 102.2; 116.6; 154.8 | 0.028 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04641221). 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. Informational only — not medical advice.