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

Chronic Pain Clinical Trial

— YOGAMAT-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641221
• Other study ID #: 202002-002-2
• Secondary ID: U01AT010863
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Butler Hospital
• Contact: Lisa Uebelacker, PhD
• Phone: 401-455-6200
• Email: luebelacker[@]butler.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In Phase 2, we will conduct a fully powered optimization trial. We will enroll 192 participants, planning to role approximately equal numbers of participants in both sites. In both phases, all participants will receive the core yoga intervention (12 weeks of weekly manualized yoga classes), with random assignment to the 4 key intervention components. Participants will be patients enrolled in methadone (MMT) or buprenorphine/naloxone (BUP) treatment with chronic pain. Enrollment period for this phase will last approximately 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use

Intervention

Behavioral:
• Weekly 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	Yoga Dosage	Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview	3 months