Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy

NCT03022890 | Completed DMC

• 1 other identifier: R34AT009432
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.To assess feasibility of research procedures, investigators have benchmarks for recruitment rate, retention for study assessments, and reliability of instructor fidelity measures.

Conditions

Opioid-Related Disorders; Pain, Chronic

Outcome Measures

Primary Outcomes (6)

• Client Satisfaction Questionnaire

  satisfaction with interventions

  3 months

• Credibility Expectancy Questionnaire (CEQ)

  credibility of interventions and expectancy of improvement due to interventions

  1 month

• Participant adherence

  Class attendance

  3 months

• Participant homework adherence

  Homework questionnaire

  3 months

• Instructor manual fidelity checklist

  3 months

• Systematic Assessment of Treatment-Emergent Events - General Inquiry

  used for documenting any adverse events

  3 months

Study Arms (2)

Hatha yoga

EXPERIMENTAL

12 weeks of hatha yoga classes, once per week

Behavioral: hatha yoga

Health education

PLACEBO COMPARATOR

12 weeks of health education classes, once per week

Behavioral: health education

Interventions

hatha yoga BEHAVIORAL

12 weeks of hour-long gentle hatha yoga classes

Hatha yoga

health education BEHAVIORAL

12 weeks of hour-long classes on nutrition, sleep, coping with pain, and other health educaiton topics

Health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in methadone maintenance treatment or buprenorphine treatment for 3 or more months;
• Plan to continue this treatment for next 6 months;
• 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);
• No current psychosis;
• Do not anticipate have surgery in the next 6 months;
• Not currently taking yoga classes, not practicing yoga once per week or more often at home;
• Not engaging in meditation once per week or more often;
• 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);
• Not pregnant;
• Aged 18 or older;
• Proficiency in English sufficient to engage in informed consent in English and understand classes taught in English.

Sponsors & Collaborators

• Butler Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Stanley Street Treatment and Resources

Fall River, Massachusetts, 02720, United States

Location

Related Publications (1)

• Uebelacker LA, Van Noppen D, Tremont G, Bailey G, Abrantes A, Stein M. A pilot study assessing acceptability and feasibility of hatha yoga for chronic pain in people receiving opioid agonist therapy for opioid use disorder. J Subst Abuse Treat. 2019 Oct;105:19-27. doi: 10.1016/j.jsat.2019.07.015. Epub 2019 Jul 24.

  PMID: 31443887 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 18, 2017
• Study Start: April 1, 2017
• Primary Completion: November 16, 2018
• Study Completion: July 1, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

US (1)