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Yoga for Chronic Pain (YOGAMAT-II Trial)

N/A

Recruiting

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Surgery requiring overnight hospitalization planned in the next 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help to optimize a yoga intervention by testing different combinations of four intervention components to see which one is most effective in increasing yoga dosage received.

Who is the study for?

This trial is for adults over 18 with chronic pain, who have been in opioid treatment for more than 3 months and plan to continue. They must be available for study classes, speak English well enough for consent and instructions, and not currently practice yoga weekly. Those with certain medical conditions or planned surgeries that could interfere are excluded.

What is being tested?

The YOGAMAT-II Phase II trial tests the effectiveness of different components of a yoga intervention to optimize dosage received by participants suffering from chronic pain. It involves random assignment to various aspects of the program alongside standard yoga classes.

What are the potential side effects?

While specific side effects are not listed, typical risks associated with yoga may include muscle strains or injuries if poses are performed incorrectly or without proper guidance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic pain most days for the last 3 months, with severe pain levels.

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I am older than 18 years.

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I have been in a methadone or buprenorphine treatment program for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have surgery planned that will keep me in the hospital overnight within the next 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Yoga Dosage

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Active Control

Group I: Yes Video/Yes One-on-One/No Text/No IncentiveActive Control1 Intervention

This group does not receive prompting Text messages or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor

Group II: No Video/No One-on-One/No Text/Yes IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes

Group III: Yes Video/No One-on-One/No Text/No IncentiveActive Control1 Intervention

This group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos

Group IV: Yes Video/No One-on-One/No Text/Yes IncentiveActive Control1 Intervention

This group does not receive One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes

Group V: Yes Video/No One-on-One/Yes Text/No IncentiveActive Control1 Intervention

This group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and prompting Text messages

Group VI: Yes Video/No One-on-One/Yes Text/Yes IncentiveActive Control1 Intervention

This group does not receive One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos, prompting Text messages, and financial Incentives to attend yoga classes

Group VII: No Video/No One-on-One/No Text/No IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes

Group VIII: No Video/No One-on-One/Yes Text/No IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or financial Incentives to attend yoga classes, but DOES receive prompting Text messages

Group IX: No Video/No One-on-One/Yes Text/Yes IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, but DOES receive prompting Text messages and financial Incentives to attend yoga classes

Group X: No Video/Yes One-on-One/No Text/No IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos or prompting Text messages or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor

Group XI: No Video/Yes One-on-One/No Text/Yes IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos or prompting Text messages, but DOES receive One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes

Group XII: No Video/Yes One-on-One/Yes Text/No IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and prompting Text messages

Group XIII: No Video/Yes One-on-One/Yes Text/Yes IncentiveActive Control1 Intervention

This group does not receive Personal Practice Videos, but DOES receive One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes

Group XIV: Yes Video/Yes One-on-One/No Text/Yes IncentiveActive Control1 Intervention

This group does not receive prompting Text messages, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes

Group XV: Yes Video/Yes One-on-One/Yes Text/No IncentiveActive Control1 Intervention

This group does not receive financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages

Group XVI: Yes Video/Yes One-on-One/Yes Text/Yes IncentiveActive Control1 Intervention

This group receives Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes

0 / 4Eligibility criteria met