Yoga for Chronic Pain

(YOGAMAT-II Trial)

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

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

What safety data exists for yoga as a treatment for chronic pain?

Yoga is generally considered safe for chronic pain treatment, with a low risk of serious adverse events comparable to other physical activities. A systematic review of 94 randomized controlled trials found no significant differences in serious or nonserious adverse events when comparing yoga to usual care or exercise. However, yoga had more nonserious adverse events compared to psychological or educational interventions. Overall, yoga is seen as a safe and effective adjunct therapy for chronic pain. ^{1 2 3 4 5}

Is yoga safe for people with chronic pain?

Yoga is generally considered safe for people with chronic pain, with a low risk of serious adverse events, similar to other forms of physical activity. While some nonserious adverse events have been reported, the overall safety profile of yoga is comparable to usual care or exercise. ^{1 2 3 4 5}

Is yoga a promising treatment for chronic pain?

Yes, yoga is a promising treatment for chronic pain. Studies show that yoga can reduce pain and improve daily activities, mood, and quality of life for people with chronic pain. It helps relax the body and mind, which can ease pain and improve overall well-being. ^{5 6 7 8 9}

How does yoga as a treatment for chronic pain differ from other treatments?

Yoga for chronic pain is unique because it combines physical postures, breathing exercises, and meditation to address both the physical and emotional aspects of pain. Unlike many treatments that focus solely on physical symptoms, yoga aims to improve overall well-being by reducing stress, enhancing relaxation, and promoting a better quality of life. ^{5 6 7 8 9}

What data supports the idea that Yoga for Chronic Pain is an effective treatment?

The available research shows that yoga can be an effective treatment for chronic pain. One study found that an 8-week yoga program improved anxiety, self-compassion, and reduced negative thoughts about pain in patients at a rehabilitation hospital. Another study indicated that yoga has positive effects on pain intensity and related impairments, especially for chronic low back pain, neck pain, and certain headaches. It also suggests that yoga is as effective and safe as other exercise interventions and physical therapy. Additionally, combining yoga with acupuncture has shown promise in managing chronic pain, highlighting yoga's flexibility and adaptability for individual needs. ^{3 8 10 11 12}

What data supports the effectiveness of the treatment Yoga, Mindfulness Program, Meditation Program, Yoga Therapy for chronic pain?

Research shows that yoga and similar mind-body practices can help reduce chronic pain, improve anxiety, and enhance self-compassion. Studies indicate that yoga is as effective as other exercise interventions and physical therapy for conditions like chronic low back pain, neck pain, and certain headaches. ^{3 8 10 11 12}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Yoga and other meditative movement therapies to reduce chronic pain. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Mind-body practices, interoception and pain: a scoping review of behavioral and neural correlates. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Yoga as an intervention for chronic pain]. [2023]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Yoga for People With Chronic Pain in a Community-Based Setting: A Feasibility and Pilot RCT. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

Yoga improves occupational performance, depression, and daily activities for people with chronic pain. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. [2015]