Status:
NOT_YET_RECRUITING
Yoga for Persistent Post-Surgical Pain (PPSP)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Persistent Post-surgical Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
More than 100 million people in the United States (US) undergo surgical procedures each year. These individuals are at risk of developing persistent post-surgical pain (PPSP), with estimates as high a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06949007
Start Date
September 15 2025
End Date
June 30 2029
Last Update
May 2 2025
Active Locations (1)
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1
Mass General Brigham
Boston, Massachusetts, United States, 02215