What this study is
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.
What's being tested
- Yoga
Intervention · BEHAVIORAL
Duration: 12 weeks; Class length: Three ∼75-minute classes per week. Two in-person/virtual (hybrid), one virtual only (MGB Zoom); Frequency: Three classes per week; Group size: 8-9 PPSP patients.
- Chronic Pain Health Education
Intervention · BEHAVIORAL
Duration: 12 weeks (short videos and PowerPoint presentations); Class length: Interactive 15-30 minute education sessions delivered via video conference (i.e., MGB Zoom); Frequency: Three classes per week; Group size: 8-9 PPSP patients.
Study details
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Persistent Post-surgical Pain
- Enrolling
- 50 people
- Starts
- 2026-03-12
- Est. completion
- 2029-06-30
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMass General Brigham
Boston, Massachusetts, United States
- Dennis Munoz-Vergara, DVM, MS, MPH · Principal investigator
Recruiting
Study team
Sponsor
Brigham and Women's Hospital
Study ID 2025P001082
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.