Recruiting

Yoga

Sponsor:

Brigham and Women's Hospital

Code:

NCT06949007

Conditions

Persistent Post-surgical Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Yoga

Chronic Pain Health Education

Study Details

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 of persistent-post surgical pan (PPSP) and the role of biological, psychophysical, and psychosocial modulators in PPSP resolution.

Conditions

Persistent Post-surgical Pain

Study ID

NCT06949007

Start date

Mar 12, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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).

Interventions

Yoga

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

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.

Primary outcome measure

  • Feasibility and Acceptability for Aim 1-Enrollment [ Time Frame: 36 months ]
  • Feasibility and Acceptability for Aim 1-Retention rate [ Time Frame: 36 months ]
  • Feasibility and Acceptability for Aim 1-Recruitment rate [ Time Frame: 36 months ]
  • Feasibility and Acceptability for Aim 1-Adherence to interventions (yoga and CPHE) [ Time Frame: 36 months ]
  • Feasibility and Acceptability for Aim 1-Intervention acceptability (yoga and CPHE) [ Time Frame: 36 months ]
  • Feasibility and Acceptability for Aim 1-Fidelity [ Time Frame: 36 months ]
  • Feasibility and Acceptability for Aim 1-Outcome collection [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Dennis Munoz-Vergara, DVM, MS, MPH

617-278-0917dmunozvergara@bwh.harvard.edu

Peter Wayne, PhD

617-732-6271pwayne@bwh.harvar.edu

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Dennis Munoz-Vergara, DVM, MS, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Persistent Post-Surgical Pain
  • Yoga
  • Randomized Controlled Trial
  • Chronic Pain Health Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-05-22.