Yoga to reduce persistent pain after torso surgery
Yoga for Persistent Post-Surgical Pain (PPSP)
NA · Brigham and Women's Hospital · NCT06949007
This pilot will try a tailored yoga program versus chronic pain health education to see if yoga reduces persistent post-surgical torso pain in adults who still have pain three months or more after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06949007 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial randomizes adults with persistent post-surgical torso pain to a yoga program adapted for postoperative limitations or to a chronic pain health education comparator. The study measures pain severity, feasibility and adherence, and collects biological, psychophysical, and psychosocial data to explore mechanisms such as inflammation and central sensitization. Participants must have at least three months of persistent post-surgical pain with moderate intensity (≥4/10) and be able to attend study visits and classes. Results are intended to inform a future fully powered translational trial.
Who should consider this trial
Good fit: Adults (18+) with persistent post-surgical torso pain lasting at least three months and average pain ≥4/10 who can attend Boston-area visits/classes and use a smartphone, tablet, or computer are ideal candidates.
Not a fit: People with non-torso surgeries (e.g., joint replacement or amputation), or with serious medical, neurological, or psychiatric conditions that prevent participation, are unlikely to benefit or be eligible for this intervention.
Why it matters
Potential benefit: If successful, this could provide a non-drug treatment option that reduces long-term pain and the need for potent analgesics in people with persistent post-surgical torso pain.
How similar studies have performed: Randomized trials have shown benefits of yoga for other chronic pain conditions, but applying and testing yoga specifically for persistent post-surgical pain is relatively novel and mechanistic data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of torso surgeries. Examples are thoracotomy, sternotomy, mastectomy and breast implant, open abdominal surgeries, and cesarean section * Completion of surgery alone or surgery and complementary pharmacological treatment * Being 18 years of age or older * 3 months with PPSP and 4/10 in BPI severity (clinically considered a moderate range) * Access to reliable modes of transportation for study visits and yoga classes * Confirmed access to and proficiency with use of a smartphone, computer, and/or tablet * Fluent in English. Exclusion criteria: * History of joint replacement, amputation, orthopedic (except thoracotomy and sternotomy), and other non-torso surgeries * Participants with health conditions that lead to difficulty complying with study protocol (i.e., completion of outcome assessments and participation in yoga or CPHE programs), including: Renal dialysis, cognitive impairment, serious neurological or psychiatric disorders; Unstable cardiovascular disease, metastatic cancer, or serious chronic medical condition; Planned surgery during the intervention period; Chronic inflammatory systemic diseases (e.g., rheumatoid arthritis); Active acute or chronic infections requiring antibiotics; Unmanaged hearing or visual impairment affecting participation in virtual classes; Substance use disorder * Pregnancy or having the intention to become pregnant within the next six months * Recent (last 3 months) or concurrent participation in weekly MBMT (e.g., yoga, tai chi, qigong) programs, physical therapy, including massage and chiropractic care, or other non-pharmacological treatment as chronic pain management, such as Mindfulness-Based Stress Reduction (MBSR) or meditation * Recent interventional pain management, defined as procedures such as corticosteroid injection, trigger point injection, and radiofrequency ablation to the cervical or lumbar region within the past 4 weeks and/or scheduled for interventional pain management procedures within the study timeframe.
Where this trial is running
Boston, Massachusetts
- Mass General Brigham — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Dennis Munoz-Vergara, DVM, MS, MPH
- Email: dmunozvergara@bwh.harvard.edu
- Phone: 617-278-0917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Post-surgical Pain, Persistent Post-Surgical Pain, Yoga, Randomized Controlled Trial, Chronic Pain Health Education