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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

YOGAMAT-II Trial 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.Check my eligibility

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.See study design

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.

YOGAMAT-II Trial 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.

YOGAMAT-II Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Yoga Dosage

YOGAMAT-II 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor

129 Previous Clinical Trials

16,226 Total Patients Enrolled

5 Trials studying Chronic Pain

283 Patients Enrolled for Chronic Pain

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,741 Total Patients Enrolled

45 Trials studying Chronic Pain

17,786 Patients Enrolled for Chronic Pain

Media Library

Yoga Clinical Trial Eligibility Overview. Trial Name: NCT04641221 — N/A

Chronic Pain Research Study Groups: Yes Video/Yes One-on-One/No Text/No Incentive, No Video/No One-on-One/No Text/Yes Incentive, Yes Video/No One-on-One/No Text/No Incentive, Yes Video/No One-on-One/No Text/Yes Incentive, Yes Video/No One-on-One/Yes Text/No Incentive, Yes Video/No One-on-One/Yes Text/Yes Incentive, No Video/No One-on-One/No Text/No Incentive, No Video/No One-on-One/Yes Text/No Incentive, No Video/No One-on-One/Yes Text/Yes Incentive, No Video/Yes One-on-One/No Text/No Incentive, No Video/Yes One-on-One/No Text/Yes Incentive, No Video/Yes One-on-One/Yes Text/No Incentive, No Video/Yes One-on-One/Yes Text/Yes Incentive, Yes Video/Yes One-on-One/No Text/Yes Incentive, Yes Video/Yes One-on-One/Yes Text/No Incentive, Yes Video/Yes One-on-One/Yes Text/Yes Incentive

Chronic Pain Clinical Trial 2023: Yoga Highlights & Side Effects. Trial Name: NCT04641221 — N/A

Yoga 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641221 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of participation in this trial?

"Affirmative. Information on clinicaltrials.gov demonstrates that this trial is in its recruitment phase, which began on February 20th 2022 and was most recently amended March 22nd of the same year. 192 participants need to be gathered from two different facilities."

Answered by AI

Are there openings for individuals to participate in the trial?

"Per clinicaltrials.gov, this medical experiment is actively searching for participants as of March 22nd 2022; its initial posting was on February 20th."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04641221.

All > Chronic Pain