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

Chronic Pain Clinical Trial

— YOGAMAT-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646148
• Other study ID #: 202002-002-1
• Secondary ID: U01AT010863
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: August 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use

Intervention

Behavioral:
• Yoga classes
All participants are invited to attend weekly yoga classes.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	CODAC Behavioral Healthcare	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Recruited	As this is a pilot study, a key outcome is number of participants recruited	4 months
Primary	Number of Yoga Teachers Trained to > 80% Fidelity to the Manual	As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity	7 months
Primary	Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected	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.)	3 months