Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy
CompletedNot applicableNCT03022890
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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)
The Specific Aims of this treatment development research are: To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education group (attention control) for persons with chronic pain who are taking methadone maintenance therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment. Participants will be enrolled in the active intervention for 3 months, and then be followed for 6 months afterwards. Investigators' aims are: 1. To assess feasibility and acceptability of both the yoga class and the health education control group. Investigators will assess credibility of the assigned intervention and expectancy for improvement for both groups at baseline, program satisfaction following program participation, participant adherence (class attendance rate and amount of home practice corresponding to assigned study arm), and instructor fidelity to the manuals. Investigators will conduct structured interviews following program participation to understand specific aspects of both programs considered attractive, useful, or not useful; we will solicit suggestions for improvements as well. 2. To assess safety, investigators will track all adverse events in a structured fashion. Investigators do not expect to see any serious adverse events definitely or probably related to study participation. 3. To assess feasibility of research procedures, investigators have benchmarks for recruitment rate, retention for study assessments, and reliability of instructor fidelity measures.
Study details
- Official title
- Pilot Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy
- Conditions
- Interventions
- Behavioral: hatha yoga
- Behavioral: health education
- Sponsor
- Butler Hospital
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2017-04-01
- Primary completion
- 2018-11-16
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Enrolled in methadone maintenance treatment or buprenorphine treatment for 3 or more months; 2. Plan to continue this treatment for next 6 months; 3. Chronic pain, defined as pain duration for at least three months (Dworkin et al., 2012), a mean score of 4 or higher on the BPI Pain Interference Scale (C. S. Cleeland \& Ryan, 1994), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week"(Breivik et al., 2008; Jensen, Chen, \& Brugger, 2003); 4. No current psychosis; 5. Do not anticipate have surgery in the next 6 months; 6. Not currently taking yoga classes, not practicing yoga once per week or more often at home; 7. Not engaging in meditation once per week or more often; 8. Medically cleared by a primary care physician or SSTAR's OAT physician for mild-moderate physical activity (this is the only criterion NOT required for Phase 1 participants); 9. Not pregnant; 10. Aged 18 or older; 11. Proficiency in English sufficient to engage in informed consent in English and understand classes taught in English. Exclusion Criteria: \-
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03022890