Yoga for Persistent Post-Surgical Pain (PPSP)
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06949007
- Status
- Recruiting
Conditions
- Persistent Post-surgical Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Yoga — BEHAVIORALDuration: 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 — BEHAVIORALDuration: 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
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.
Key Dates
- Start date
- Mar 12, 2026
- Status verified
- May 2026
- Primary completion
- Sep 30, 2028
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Yoga groupYoga 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.
- Active Comparator: Chronic Pain Health Education (CPHE)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).
Primary Outcome Measure
Feasibility and Acceptability for Aim 1-Enrollment [ Time Frame: 36 months ]
Central Contacts
- Dennis Munoz-Vergara, DVM, MS, MPH617-278-0917
- Peter Wayne, PhD617-732-6271
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mass General Brigham | Boston | Massachusetts | 02215 | Dennis Munoz-Vergara, DVM, MS, MPH (PRINCIPAL_INVESTIGATOR) |
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