Yoga for Chronic Pain

(YOGAMAT-II Trial)

No longer recruiting at 1 trial location

Overseen By Lucy Lorin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Must be taking: MMT, BUP

Disqualifiers: Active malignancy, Neurologic deficits, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different components of yoga can aid individuals with chronic pain. All participants will attend yoga classes, with some receiving additional support such as videos, personal sessions, text reminders, or incentives. The researchers aim to identify the best combination of these elements to enhance yoga practice and improve pain management. This trial suits those who have experienced chronic pain for over three months and are undergoing ongoing medical treatment for opioid use disorder. Participants should not currently practice yoga regularly and must have a safe space to practice at home. As an unphased trial, this study provides a unique opportunity to explore innovative methods for managing chronic pain through yoga.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must be enrolled in MMT or BUP treatment for over 3 months and plan to continue, it seems you can stay on those medications.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be enrolled in MMT (Methadone Maintenance Treatment) or BUP (Buprenorphine) treatment for over 3 months and plan to continue, it seems you can stay on these medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that yoga safely helps manage long-term pain. A 2017 review of 30 studies found that mindfulness meditation, often including yoga, reduced chronic pain for many individuals. Another study found that a 12-week online yoga program was safe and effective for those with long-term lower back pain. Additionally, yoga effectively manages both ongoing and sudden pain, especially for individuals with back or neck issues. Overall, these findings suggest that yoga is well-tolerated and safe for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using yoga for chronic pain because it offers a holistic approach that current treatments often lack. Unlike standard pain management options like medications or physical therapy, yoga incorporates both physical and mental elements, potentially improving not just physical symptoms but also stress and emotional well-being. Additionally, yoga is a low-risk, non-invasive practice that can be tailored to individual needs, providing a flexible alternative that might reduce reliance on pharmaceuticals. This trial aims to explore how different combinations of yoga instruction, including videos, one-on-one sessions, text reminders, and financial incentives, might enhance treatment adherence and effectiveness.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Studies have shown that yoga can help manage chronic pain. For example, one study found that a 12-week online yoga program significantly benefited people with chronic low back pain. This trial will explore various approaches to yoga therapy, including personal practice videos, one-on-one sessions with a yoga instructor, prompting text messages, and financial incentives to attend classes. Other research suggests that combining yoga with traditional pain medication can effectively relieve pain. Programs focusing on mindfulness and body movement, similar to yoga, have also made pain less bothersome. Overall, strong evidence supports yoga as a safe and effective way to manage chronic pain. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I plan to continue my treatment for the next 6 months.

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

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

I do not have any health issues that would make doing yoga unsafe.

You don't have a safe and private space for doing yoga at home or joining online yoga classes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the core yoga intervention with random assignment to intervention components

12 weeks

Weekly yoga classes

Follow-up

Participants are monitored for yoga dosage and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yoga

Trial Overview 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.

How Is the Trial Designed?

Group I: Yes Video/Yes One-on-One/No Text/No Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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 Incentive Active Control 1 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

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

An 8-week Mindfulness-Based Stress Reduction (MBSR) program was found to be as effective as a multidisciplinary pain intervention (MPI) program in reducing pain intensity and pain-related distress in patients with chronic pain, based on a study of 99 participants.

Both interventions led to statistically significant improvements in pain and mood symptoms, but the overall differences between MBSR and MPI were not significant, indicating that both approaches can be beneficial for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. Wong, SY., Chan, FW., Wong, RL., et al.[2015]

An 8-week Hatha Yoga program significantly improved anxiety levels, self-compassion, and pain catastrophizing in 10 inpatients at a rehabilitation hospital, indicating its potential as a therapeutic intervention.

The study highlights the effectiveness of modified yoga practices for individuals with limited mobility, suggesting that such interventions can enhance psychological well-being and pain management in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study. Curtis, K., Kuluski, K., Bechsgaard, G., et al.[2022]

Yoga and other meditative movement therapies have been found to improve chronic pain symptoms in adults, based on a review of various studies.

It is recommended that any exercise therapy program, including yoga, should be conducted under the guidance of certified and qualified instructors to ensure safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga and other meditative movement therapies to reduce chronic pain. Achilefu, A., Joshi, K., Meier, M., et al.[2018]

Yoga has been shown to significantly reduce pain intensity and related impairments in individuals with chronic low back pain, and it is also effective for chronic neck pain and certain headaches.

The efficacy and safety of yoga are comparable to other exercise interventions and individualized physical therapy, highlighting its potential as a valuable treatment option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Yoga as an intervention for chronic pain]. Anheyer, D., Cramer, H.[2023]

A new yoga therapy protocol was developed for chronic pain management, combining flexibility for individual care with standardized practices, making it suitable for use in federally qualified health centers.

The protocol includes various categories of practices such as stabilizing poses and breathing techniques, ensuring that each participant receives personalized care while maintaining consistency across sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Flexible Yoga Therapy Protocol in the Group Acupuncture Therapy and Modified Yoga (GAPYOGA) Pilot Study. Moonaz, S., Luthria, T., Whitehead, AM., et al.[2023]

In a pilot randomized control trial involving 83 participants with chronic pain, an 8-week yoga intervention significantly improved occupational performance and satisfaction, with performance scores increasing by 27% and satisfaction scores by 78%.

Participants in the yoga group also showed a decrease in depression symptoms, with scores dropping significantly, indicating that yoga may be an effective holistic treatment for managing chronic pain and its associated challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga improves occupational performance, depression, and daily activities for people with chronic pain. Schmid, AA., Van Puymbroeck, M., Fruhauf, CA., et al.[2019]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

Yoga has been shown to have positive effects on various health conditions, particularly chronic pain, hypertension, depression, and supportive cancer care, based on numerous randomized controlled trials.

The risk of serious adverse events from practicing yoga is very low, making it a safe and effective complementary therapy alongside other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Where and How does Yoga Work? - A Scientific Overview]. Cramer, H.[2017]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

Yoga and meditation can significantly influence chronic pain by promoting relaxation and reducing hyper arousal in the nervous system, which helps alleviate muscle tension and improve overall well-being.

Practices like pranayama and asanas not only enhance physical health but also positively impact emotional and mental states, effectively reducing anxiety and depression associated with chronic pain, thereby improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on yoga inputs in the management of chronic pain. Vallath, N.[2022]

An 8-week yoga program for people with chronic pain was found to be feasible and resulted in significant improvements in pain interference scores, indicating better daily functioning.

Participants in the yoga group reported better body responsiveness and pain management compared to those receiving usual care, suggesting that yoga may be an effective complementary treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for People With Chronic Pain in a Community-Based Setting: A Feasibility and Pilot RCT. Schmid, AA., Fruhauf, CA., Sharp, JL., et al.[2020]

This scoping review analyzed 690 articles and found that interoceptive techniques, which involve awareness and acceptance of bodily sensations, may be crucial in how yoga helps alleviate chronic pain.

Only three studies directly connected yoga, interoception, and pain, highlighting a need for more research in this area to better understand how yoga can be effectively used for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body practices, interoception and pain: a scoping review of behavioral and neural correlates. Voss, S., Boachie, DA., Nieves, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4941786/

Mindfulness meditation–based pain relief: a mechanistic ... The MBSR and CBT programs were found to be significantly more effective at reducing pain intensity and reports of pain being bothersome when compared to usual ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825746

Effectiveness of Virtual Yoga for Chronic Low Back Pain Findings of this study indicate that a 12-week therapeutic virtual yoga program for chronic low back pain is feasible, safe, and effective.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590019306741

(382) Yoga Based Self-Management Program for Chronic ... Results suggest that yoga therapy, as an adjunct to traditional analgesic therapy, can be an efficacious tool in the management of chronic pain.

4. link.springer.com link.springer.com/article/10.1007/s12671-022-02023-1

Mindfulness-Based Pain Management (MBPM) for Chronic ... Mindfulness-based pain management (MBPM) has evidenced significant positive changes in patients with chronic pain, but so far, no RCT study has been conducted.

5. rand.org rand.org/pubs/research_reports/RR1317.html

Mindfulness Meditation for Chronic Pain Mindfulness meditation was associated with a small effect of improved pain symptoms compared with control groups in a meta-analysis of 24 randomized controlled ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04457388

NCT04457388 | Tele-Yoga Therapy for Chronic Pain Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526590011007929

Effects of Yoga Interventions on Pain and Pain-Associated ... This meta-analysis suggests that yoga is a useful supplementary approach with moderate effect sizes on pain and associated disability.

8. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH A 2017 analysis of 30 studies (2,561 participants) found that mindfulness meditation was more effective at decreasing chronic pain than several ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8719171/

Effectiveness and safety of yoga to treat chronic and acute ... Yoga can be an effective and safe practice to control chronic and acute pain, primarily in patients with low back or chronic cervical pain.