Yoga for Chronic Pain
(YOGAMAT-II Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Butler Hospital
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345What 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.
46789Is 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.
39101112Eligibility Criteria
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.
+3 more
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.
+4 more
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Medical CenterBoston, MA
CODAC Behavioral HealthcareProvidence, RI
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Who Is Running the Clinical Trial?
Butler HospitalLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Yoga and other meditative movement therapies to reduce chronic pain. [2018]In adults with chronic pain, do yoga and other meditative movement therapies to improvement in chronic pain symptoms?
Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study. [2022]Introduction. The purpose of this study was to evaluate a specialized yoga intervention for inpatients in a rehabilitation and complex continuing care hospital. Design. Single-cohort repeated measures design. Methods. Participants (N = 10) admitted to a rehabilitation and complex continuing care hospital were recruited to participate in a 50-60 min Hatha Yoga class (modified for wheelchair users/seated position) once a week for eight weeks, with assigned homework practice. Questionnaires on pain (pain, pain interference, and pain catastrophizing), psychological variables (depression, anxiety, and experiences with injustice), mindfulness, self-compassion, and spiritual well-being were collected at three intervals: pre-, mid-, and post-intervention. Results. Repeated measures ANOVAs revealed a significant main effect of time indicating improvements over the course of the yoga program on the (1) anxiety subscale of the Hospital Anxiety and Depression Scale, F(2,18) = 4.74, p < .05, and ηp2 = .35, (2) Self-Compassion Scale-Short Form, F(2,18) = 3.71, p < .05, and ηp2 = .29, and (3) Magnification subscale of the Pain Catastrophizing Scale, F(2,18) = 3. 66, p < .05, and ηp2 = .29. Discussion. The results suggest that an 8-week Hatha Yoga program improves pain-related factors and psychological experiences in individuals admitted to a rehabilitation and complex continuing care hospital.
Mind-body practices, interoception and pain: a scoping review of behavioral and neural correlates. [2023]Chronic pain is a significant source of suffering in the United States, and many individuals increasingly turn towards yoga for pain relief. However, little is known regarding how yoga improves pain. Herein we seek to examine the scope of the literature linking mind-body practices, pain and interoception; an emerging mechanism by which yoga may improve chronic pain.
[Yoga as an intervention for chronic pain]. [2023]The use of yoga, especially as an intervention for chronic pain, is increasing worldwide. Available data on chronic low back pain, within limits also for chronic neck pain and certain types of headache, show statistically significant positive effects related to pain intensity and pain-related impairments. The data provide evidence that yoga is at least equal in efficacy and safety to other exercise interventions as well as individualized physical therapy. The dose of the intervention seems to be of secondary importance, but the establishment of a long-term independent practice after initial supervision seems to be essential; however, for other pain disorders there is still a need for research.
Development and Implementation of a Flexible Yoga Therapy Protocol in the Group Acupuncture Therapy and Modified Yoga (GAPYOGA) Pilot Study. [2023]Chronic pain is the most common reason U.S. adults seek medical care. Acupuncture and yoga show effectiveness, and a recent study assessed the feasibility of these two modalities for chronic pain at federally qualified health centers. Yoga research is rarely individualized, which is important for chronic pain treatments. Six experienced yoga professionals drew on research and clinical experience to co-create a yoga therapy protocol standardized for replication with flexibility for individual care. Yoga therapy was to be combined with a previously developed flexible acupuncture intervention in a feasibility trial. Categories of practices were identified as relevant and appropriate for chronic pain management in a federally qualified health center. Within each category, specific practices were listed for each provider to select as appropriate. These were based on usefulness for chronic pain, safety, ease of teaching/learning, and cultural appropriateness. The final manual included: (1) stabilizing poses, (2) mobilizing poses, (3) breathing practices, (4) relaxation, (5) mental practices, and (6) applied philosophy. Each participant began with an intake to inform practice selection. Ten subsequent sessions were 30 minutes each, with 1-2 participants receiving simultaneous care. First sessions included diaphragmatic breathing and some physical postures. All practices were adapted. Over 10 sessions, at least one practice from each category was included. Participants were given instructions/images for home practice. Individual charting ensured continuity of care and consistency across sessions. In evidence-informed practice, there exists a tension between replicability and individualization. A flexible protocol allows both. Future application in research and clinical settings will help to determine feasibility and effectiveness.
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P
[Where and How does Yoga Work? - A Scientific Overview]. [2017]As a traditional health care system, yoga combines physical activity, breathing techniques and meditation. It is increasingly used as a preventive or therapeutic means. Yoga has been researched in hundreds of randomized controlled trials. Positive effects are especially found for chronic pain conditions, hypertension, depression and in supportive cancer care. While there are case reports of serious adverse events associated with yoga, the risk seems to be extremely low and comparable to other forms of physical activity. Yoga can thus be considered as a safe and effective adjunct therapy for a number of conditions.
A large-scale survey of adverse events experienced in yoga classes. [2022]Yoga is a representative mind-body therapy of complementary and alternative medicine. In Japan, yoga is practiced widely to promote health, but yoga-associated adverse events have also been reported. To date, the frequencies and characteristics of yoga-related adverse events have not been elucidated. This study was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
Yoga for People With Chronic Pain in a Community-Based Setting: A Feasibility and Pilot RCT. [2020]The purpose of this feasibility pilot study was to assess benefits of 8 weeks of yoga in people with chronic pain. Participants completed baseline assessments and were randomized to yoga or usual care. Yoga was offered twice a week for 8 weeks. We assessed feasibility and the Brief Pain Inventory (BPI) was the primary outcome, assessing pain-severity and pain interference on daily activities. Eighty-three people were recruited; 67 people completed the study and were included in the analyses. Average age of participants was 50.78 ± 10.43 years and most participants had pain >10 years. The intervention appeared feasible and there were significant improvements (P < .05) in multiple measures for the yoga group, including a decrease in BPI interference scores from 7.15 ± 1.70 to 6.14 ± 2.21 (P = .007). There was a significant difference in body responsiveness and pain management scores between groups at 8 weeks. It appears that yoga was feasible and positively influenced multiple outcome measures for people with chronic pain.
Perspectives on yoga inputs in the management of chronic pain. [2022]Chronic pain is multi-dimensional. At the physical level itself, beyond the nociceptive pathway, there is hyper arousal state of the components of the nervous system, which negatively influences tension component of the muscles, patterns of breathing, energy levels and mindset, all of which exacerbate the distress and affect the quality of life of the individual and family. Beginning with the physical body, Yoga eventually influences all aspects of the person: vital, mental, emotional, intellectual and spiritual. It offers various levels and approaches to relax, energize, remodel and strengthen body and psyche. The asanas and pranayama harmonize the physiological system and initiate a "relaxation response" in the neuro endocrinal system. This consists of decreased metabolism, quieter breathing, stable blood pressure, reduced muscle tension, lower heart rate and slow brain wave pattern. As the neural discharge pattern gets modulated, hyper arousal of the nervous system and the static load on postural muscle come down. The function of viscera improves with the sense of relaxation and sleep gets deeper and sustained; fatigue diminishes. Several subtle level notional corrections can happen in case the subject meditates and that changes the context of the disease, pain and the meaning of life. Meditation and pranayama, along with relaxing asanas, can help individuals deal with the emotional aspects of chronic pain, reduce anxiety and depression effectively and improve the quality of life perceived.
Yoga improves occupational performance, depression, and daily activities for people with chronic pain. [2019]Chronic pain is a complex accumulation of physical, psychological, and social conditions, thus interventions that address pain and promote occupational performance are needed. A holistic intervention, with mind and body components, is likely necessary to best treat the complexities of chronic pain. Thus, we developed and tested a yoga intervention for people with chronic pain.
Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. [2015]Research suggests that an 8-week Mindfulness-Based Stress Reduction (MBSR) program (a structured form of meditation) might be effective in the treatment of various health problems including chronic pain. Our objective was to compare the clinical effectiveness of the MBSR program with a multidisciplinary pain intervention (MPI) program in terms of pain intensity, pain-related distress, quality of life, and mood in patients with chronic pain.