50 Participants Needed

Yoga for Persistent Post-Surgical Pain

PW
DM
Overseen ByDennis Munoz-Vergara, DVM, MS, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Yoga for Persistent Post-Surgical Pain?

Research suggests that yoga can help reduce pain and anxiety after surgery, as seen in studies with patients who had spine and gynecologic surgeries. Additionally, yoga has shown positive effects on chronic pain conditions like low back pain, making it a promising option for managing post-surgical pain.12345

Is yoga generally safe for humans?

Yoga is generally considered safe for humans, with the risk of serious injuries being extremely low and similar to other physical activities. Most adverse events reported are nonserious, and yoga can be a safe addition to other treatments for various conditions.678910

How does yoga differ from other treatments for persistent post-surgical pain?

Yoga is unique because it focuses on holistic well-being, incorporating physical postures, breathing exercises, and meditation, which can help manage pain by reducing stress and improving mental health, unlike traditional pain medications that primarily target physical symptoms.1112131415

What is the purpose of this trial?

The overall goal of this project is to complete a pilot feasibility randomized controlled trial (RCT) to inform a future fully-powered translational study evaluating yoga for management and resolution of persistent-post surgical pan (PPSP) and the role of biological, psychophysical, and psychosocial modulators in PPSP resolution.

Eligibility Criteria

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.
See 3 more

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.
See 2 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Yoga groupExperimental Treatment1 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 Control1 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).

Find a Clinic Near You

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+

Findings from Research

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.
Protocol for Testing Yoga to Reduce Post-Lumbar Spine Surgery Pain: A Methodology Article.Sharma, NK., Aoyagi, K., Crouch Young, MK., 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.
[Yoga as an intervention for chronic pain].Anheyer, D., Cramer, H.[2023]
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.
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]

References

Protocol for Testing Yoga to Reduce Post-Lumbar Spine Surgery Pain: A Methodology Article. [2022]
Feasibility of a Brief Yoga Intervention for Improving Acute Pain and Distress Post Gynecologic Surgery. [2019]
[Yoga as an intervention for chronic pain]. [2023]
Literature Review of Research on Chronic Pain and Yoga in Military Populations. [2020]
Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study. [2022]
Injuries and other adverse events associated with yoga practice: A systematic review of epidemiological studies. [2018]
[Where and How does Yoga Work? - A Scientific Overview]. [2017]
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]
A large-scale survey of adverse events experienced in yoga classes. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Returning to Yoga Practice and Teaching After Total Hip Arthroplasty. [2021]
Effect of Karamardādi Yoga versus diclofenac sodium in post-operative pain management: A randomized comparative clinical trial. [2020]
Persistent postoperative pain: where are we now? [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Periarticular regional analgesia in total knee arthroplasty: a review of the neuroanatomy and injection technique. [2022]
Chronic postoperative pain: ubiquitous and scarcely appraised: narrative review. [2022]
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