Yoga for Persistent Post-Surgical Pain

Overseen By Dennis Munoz-Vergara, DVM, MS, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Antibiotics

Disqualifiers: Joint replacement, Amputation, Orthopedic, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether yoga can reduce or resolve persistent pain after surgery. Participants will either join a yoga program or receive education about chronic pain to determine which is more effective. The trial seeks individuals who have undergone torso surgery (such as a mastectomy or cesarean) and have experienced ongoing pain for at least three months. Participants should be comfortable using a smartphone or computer and able to travel for study visits and yoga classes. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on yoga as a treatment, so you may not need to change your medication routine, but it's best to confirm with the study coordinators.

What prior data suggests that yoga is safe for managing persistent post-surgical pain?

Research shows that yoga is generally safe for managing pain. Studies have found that yoga can effectively and safely control both long-term and short-term pain, especially for individuals with lower back or neck pain. For those who have undergone surgery, yoga can safely reduce pain and anxiety, and it might even lessen the need for pain medications.

The risk of serious side effects from yoga is very low, making it a safe option alongside other treatments. This suggests yoga could be a good choice for those seeking a gentle way to manage pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Yoga for Persistent Post-Surgical Pain program because it offers a holistic approach distinct from traditional pain management options like medication and physical therapy. This yoga program is specially tailored to address the unique needs of post-surgical patients, incorporating posture adjustments and verbal intensity cues to ensure safety and effectiveness. The program is not just about physical postures; it integrates mindfulness and relaxation techniques that could potentially reduce pain perception and improve overall well-being. By adapting and validating this yoga approach through participant insights and expert guidance, this treatment has the potential to offer a non-invasive, empowering alternative for those suffering from persistent post-surgical pain.

What evidence suggests that yoga might be an effective treatment for persistent post-surgical pain?

Research has shown that yoga, which participants in this trial may receive, can help reduce pain and anxiety after surgery. Studies have found it especially beneficial for individuals with ongoing pain following surgeries, such as those on the spine or in the gynecologic area. Those who practice yoga often report less pain compared to individuals who maintain their usual routines. A special yoga program, tested in this trial, proved effective for individuals after lumbar spine surgery. Overall, yoga offers a promising method for managing long-lasting pain post-surgery. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing long-lasting pain after surgery, known as Persistent Post-Surgical Pain (PPSP). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions related to the study's focus.

Inclusion Criteria

Confirmed access to and proficiency with use of a smartphone, computer, and/or tablet

Fluent in English

I have had surgery on my chest, abdomen, or breast.

Exclusion Criteria

Pregnancy or having the intention to become pregnant within the next six months

I have been participating in non-drug pain management like mindfulness or physical therapy recently.

I have had surgery on parts of my body other than my chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including blood samples and psychophysical tests

1 week

1 visit (in-person)

Treatment

Participants undergo a 12-week intervention with either yoga or chronic pain health education

12 weeks

Weekly sessions (virtual)

Post-Intervention Assessment

Participants complete post-intervention assessments including blood samples and psychophysical tests

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Yoga

Trial Overview The trial is testing whether yoga can help manage and potentially resolve PPSP. It compares the effects of yoga with chronic pain health education in a pilot randomized controlled trial to prepare for a larger future study.

How Is the Trial Designed?

Group I: Yoga group Experimental Treatment 1 Intervention

Yoga Program Procedure This program was adapted and validated from a previously validated yoga program for patients with chronic lower back pain (cLBP), originally designed and clinically evaluated by Dr. Saper. While the program includes postures targeting the torso, modifications were made to address the specific needs of post-surgical patients (e.g., verbal intensity cues, duration of pose holding, and posture adjustments). The adaptation and validation process was guided by a modified Delphi approach with an embedded focus group, involving both an expert panel and PPSP participants. Participants attended a sample yoga class and shared insights during a focus group discussion, which informed program modifications.

Group II: Chronic Pain Health Education (CPHE) Active Control 1 Intervention

Chronic Pain Health Education Procedures (CPHE) To partially control for attention and expectation effects associated with yoga therapy, participants randomized to the control group will receive a modified version of an education-based intervention that we recently developed and validated for an ongoing study evaluating migraine pain. Participants assigned to the CPHE (Chronic Pain Health Education) arm will attend 12 interactive 15-30-minute education sessions delivered via video conference. Each session will be offered three times per week, allowing participants the option to attend multiple sessions to reinforce the material. Most sessions will include a short educational video, which will be watched together by participants and the RA. After each video, the RA will facilitate a structured, scripted discussion on the topic. Example session topics include: Understanding Clinical Trials, Biology of Persistent Post-Surgical Pain (PPSP).

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

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]

This pilot study aims to evaluate the feasibility and effectiveness of a tailored yoga program for managing acute and subacute postoperative pain in patients aged 40 to 80 undergoing lumbar spine surgeries, with a focus on adherence and compliance as primary outcomes.

The program includes in-person sessions during hospitalization and an 8-week home-based component, assessing secondary outcomes like pain, anxiety, and functional recovery, which could provide a non-pharmacological alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Testing Yoga to Reduce Post-Lumbar Spine Surgery Pain: A Methodology Article. Sharma, NK., Aoyagi, K., Crouch Young, MK., et al.[2022]

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 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 systematic review of nine studies involving over 18,000 participants found that 22.7% of yoga practitioners experienced adverse events during classes, with the most common injuries being sprains and strains.

While yoga practitioners had a similar risk of falls compared to non-practitioners, they did have a higher risk of meniscus injuries, indicating that while yoga is generally safe, individuals with existing health issues should consult a doctor before starting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injuries and other adverse events associated with yoga practice: A systematic review of epidemiological studies. Cramer, H., Ostermann, T., Dobos, G.[2018]

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]

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]

Citations

1. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/persistent_relief__a

A study of yoga for people with Persistent Post-Surgical Pain We're conducting a study on yoga for persistent post-surgical pain (PPSP), a challenging condition that can persist for months or even years following surgery.

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

Effectiveness and safety of yoga to treat chronic and acute ... Results were favourable to yoga compared with usual daily care, particularly in low back and cervical pain cases.

3. withpower.com withpower.com/trial/yoga-for-persistent-post-surgical-pain-6f000

Yoga for Persistent Post-Surgical Pain · Info for Participants Research suggests that yoga can help reduce pain and anxiety after surgery, as seen in studies with patients who had spine and gynecologic surgeries.

4. lidsen.com lidsen.com/journals/icm/icm-10-03-041

Evaluation of the Transitional Pain Service Specialized ... The objective of this RCT was to evaluate the feasibility and efficacy of a specialized Iyengar-informed yoga intervention for individuals with persistent post- ...

5. liebertpub.com liebertpub.com/doi/10.1089/jicm.2023.0096

Tailored Yoga Intervention for Postlumbar Spine Surgical ... The findings suggest that a tailored yoga program is feasible and can be delivered per protocol for acute LSS postoperative symptoms. The ...