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Completed

NCT Number: NCT04646148

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

In Phase 1, we will enroll 10 participants at each recruitment site (n=20). The purpose of Phase 1 (MOST Preparation Phase) is to allow us to establish and refine procedures at these new sites and document aspects of feasibility, including our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer these components; d) run classes; and e) collect follow-up assessments. Enrollment period for this phase will last approximately 4 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga classes

Behavioral

All participants are invited to attend weekly yoga classes.

Primary outcomes

  1. Number of Participants Recruited

    Time frame: 4 months

    As this is a pilot study, a key outcome is number of participants recruited

  2. Number of Yoga Teachers Trained to > 80% Fidelity to the Manual

    Time frame: 7 months

    As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity

  3. Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected

    Time frame: 3 months

    As this is a pilot study, an outcome is percentage of weeks where data on amount of yoga personal practice were collected. The total number of weeks possible = 12. These data are most important as they will be used to derive the primary outcome in the next phase of this research (total amount of yoga practice.)

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I

Acronym: YOGAMAT-II

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2020
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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