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Yoga for Persistent Post-Surgical Pain (PPSP)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 of persistent-post surgical pan (PPSP) and the role of biological, psychophysical, and psychosocial modulators in PPSP resolution.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Mass General Brigham
RECRUITING
Boston
Contact Information
Primary
Dennis Munoz-Vergara, DVM, MS, MPH
dmunozvergara@bwh.harvard.edu
617-278-0917
Backup
Peter Wayne, PhD
pwayne@bwh.harvar.edu
617-732-6271
Time Frame
Start Date: 2026-01-31
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 50
Treatments
Experimental: Yoga group
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.
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).
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: National Center for Complementary and Integrative Health (NCCIH)

This content was sourced from clinicaltrials.gov