Yoga for Persistent Post-Surgical Pain (PPSP)

May 20, 2026 updated by: Dennis Wilson Munoz Vergara, Brigham and Women's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 as 70% for some procedures (e.g., post-thoracotomy, hernial repair, cholecystectomy, cesarean section, sternotomy). PPSP, defined as pain in the surgical area that lasts more than 3 months after surgery, is a unique syndrome of chronic pain. Prior studies suggest that inflammation plays a major role in the development of PPSP, along with peripheral and central sensitization due to nerve damage, and weakening of the endogenous central opioid and endocannabinoid systems. Thus, PPSP provides a unique opportunity that invites translational research.

Currently, the main strategy for managing PPSP is pharmacological treatment. However, long-term use of potent analgesics is associated with untoward side effects (e.g., priming to develop PPSP). A growing body of research supports the benefit of mind-body movement therapies (MBMT), such as yoga, in treating chronic pain; however, little attention has been devoted to adapting a yoga program for the specific needs that PPSP patients may face (e.g., range of motion). Moreover, while randomized controlled trials (RCTs) support that yoga alleviates pain, the mechanisms underlying its therapeutic benefits are largely unclear.

Preclinical and clinical studies suggest yoga has the potential to alter systemic levels of inflammatory mediators (i.e., cytokines and oxylipins) via body movement and stretching. Given that inflammatory processes may contribute to more severe and prolonged pain after surgery, yoga practice may mitigate the development of PPSP via the modulation of circulating levels of inflammatory and endocannabinoid mediators, resulting in endogenous analgesia. Evaluation of the links between yoga and post-surgical pain, with modulation of systemic levels of these potential mediators, is a novel area of inquiry, which may inform the practical and safe use of yoga in postoperative patients.

This pilot translational RCT proposes comparing a yoga program versus a chronic pain health education (CPHE) program in individuals with PPSP. This pilot RCT will help collect essential preliminary data to inform a future translational trial evaluating a widely available and adaptable intervention (yoga) for a highly prevalent and debilitating pain condition (PPSP) that impacts multiple dimensions of whole-person health.

Multiple indicators of feasibility and acceptability of the intervention and procedures will be evaluated. Upon enrollment, participants (N=50) will be randomly assigned 1:1 to one of the two treatment groups using a permuted block randomization, with block sizes of 2 and 4 to either the yoga group or the health education control group.

Following the study timeline, participants will be asked to complete three assessments: baseline (T1-prior to randomization), post-intervention (T2- ~ 12 weeks post-T1), and 3 months post-intervention (T3- ~24 weeks post-T1). Each assessment will include blood samples for select outcomes related to inflammation (e.g., cytokines), psychophysical assessment of pain and pain sensitivity test (i.e., Quantitative Sensory Testing), psychosocial patient-centered outcomes (i.e., PROMIS-29), clinical neuropathy (i.e., S-LANSS), and self-patient-reported pain interference and severity (i.e., BPI). Participants in the yoga groups (approximately 3 cohorts of 8-9 participants each) will be asked to provide brief feedback on acceptability of session content via a weekly survey.

This study will allow us to address our primary Aim 1: To design and conduct a pilot feasibility RCT of yoga in individuals with PPSP. This aim has three components: a) To adapt a validated yoga program to individuals with PPSP ; b) To assess multiple indicators of feasibility and acceptability, such as recruitment, retention, adherence, and acceptability and; c) To assess feasibility of collecting PPSP-related outcomes. An secondary exploratory Aim 2 will explore the longitudinal relationship between yoga or an education control group on changes in PPSP-related inflammatory markers (e.g., IL-6) and other known psychophysical (i.e., QST), and psychosocial (e.g., PROMIS-29) modulators of PPSP to further inform our conceptual framework and the design of a larger trial assessing the impact of yoga on PPSP resolution.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Mass General Brigham
        • Principal Investigator:
          • Dennis Munoz-Vergara, DVM, MS, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • Yoga exercise
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).
Behavioral: 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.
Other Names:
  • CPHE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability for Aim 1-Enrollment
Time Frame: 36 months
≥ 30% of contacted eligible participants will enroll. Assessment Instrument: REDCap report.
36 months
Feasibility and Acceptability for Aim 1-Retention rate
Time Frame: 36 months

≥65% of randomized participants will attend all study visits and complete all outcome assessments.

Assessment instrument: REDCap Report of three in-person study visits.
36 months
Feasibility and Acceptability for Aim 1-Recruitment rate
Time Frame: 36 months

Recruitment will be completed within 18 months (2-3 participants/month).

Assessment instrument: REDCap report.
36 months
Feasibility and Acceptability for Aim 1-Adherence to interventions (yoga and CPHE)
Time Frame: 36 months
≥75% of randomized participants will adhere to the intervention programs. Target: ≥75% Assessment instrument via Mycap survey-Meeting 75% adherence in the 12-week yoga program requires attending at least one class per week for at least 9 weeks. For home practice, 75% adherence (2+ days/week) corresponds to at least 18 sessions over 12 weeks. Participants can meet this goal by virtually attending additional group classes (up to three per week) or by engaging in 15-30 minutes of home practice, recorded in their weekly MyCap survey. Meeting 75% adherence in the 12-week CPHE program requires attending at least one class per week for at least 9 weeks (attendance to weekly PowerPoint presentation and completeness of weekly MyCap survey on CPHE program satisfaction).
36 months
Feasibility and Acceptability for Aim 1-Intervention acceptability (yoga and CPHE)
Time Frame: 36 months
≥80% of participants will rate the intervention favorably. Target: ≥80% Assessment instrument via REDCap survey asking participants to rate (0=not at all to 10=very much) enjoyment, convenience, helpfulness, and overall satisfaction after each session and at T2 (post-intervention).
36 months
Feasibility and Acceptability for Aim 1-Fidelity
Time Frame: 36 months

≥70% adherence to the structured yoga class components in 10% of observed classes.

Assessment instrument: REDCap Report.
36 months
Feasibility and Acceptability for Aim 1-Outcome collection
Time Frame: 36 months

≥80% of PPSP-related outcome measures will be collected.

Assessment instruments: REDCap report for clinical, psychophysical, and biological outcome collection.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
Time Frame: 48 months

Descriptive statistics and exploratory treatment assignment effects on clinical outcomes-Brief Pain Inventory (BPI) scores for pain severity (composite of the four pain items-a mean severity score) and interference (mean of the seven interference items).

Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3). Higher scores indicate greater pain.
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
Time Frame: 48 months

Descriptive statistics and exploratory treatment assignment effects on clinical outcomes-PROMIS-29 T scores for the seven domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities).

Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).

A higher PROMIS T-score represents more of the concept being measured.
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
Time Frame: 48 months

Descriptive statistics and exploratory treatment assignment effects on clinical outcomes-S-LANSS score from 7 items to assess neuropathic symptoms and signs (range 0-24).

Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).

Higher scores indicate greater neuropathic symptoms and signs.
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related biological modulators of PPSP in the yoga and CPHE groups
Time Frame: 48 months

Descriptive statistics and exploratory treatment assignment effects on inflammatory and analgesic mediators: Multi-analyte flow assay (e.g., customized Legendplex) for cytokines (ng or pg/mL). Lipid extraction and LC-MS-MS or ELISA for oxylipins and endocannabinoids (ng or pg/mL).

Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Temporal summation of pain-TSP)
Time Frame: 48 months
Descriptive statistics and exploratory treatment assignment effects on psychophysical outcomes-Brief bedside-adapted Quantitative Sensory Testing (QST): Pinprick applicators (force expressed in Newtons and 3-point ordinal scale: absent, impaired, normal) for TSP. Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Painful After Sensation-PAS)
Time Frame: 48 months
Descriptive statistics and exploratory treatment assignment effects on psychophysical outcomes-Brief bedside-adapted Quantitative Sensory Testing (QST): Pinprick applicators (force expressed in Newtons and 3-point ordinal scale: absent, impaired, normal) for PAS. Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Pressure Pain Threshold-PPTh)
Time Frame: 48 months
Descriptive statistics and exploratory treatment assignment effects on psychophysical outcomes-Brief bedside-adapted Quantitative Sensory Testing (QST): Algometer (force expressed in units of kilopascals (kPa) or kg/cm2) for PPTh. Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).
48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Pressure Pain Tolerance-PPTo)
Time Frame: 48 months
Descriptive statistics and exploratory treatment assignment effects on psychophysical outcomes-Brief bedside-adapted Quantitative Sensory Testing (QST): Algometer (force expressed in units of kilopascals (kPa) or kg/cm2) for PPTo. Assess at baseline (T1), 12-week post-intervention (T2), and 12-week follow-up (T3).
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P001082
  • 1K01AT012889-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As this pilot study is a randomized trial, unblinded data involving the randomized treatments will be shared after the study database is locked and the main trial findings are disseminated. As done with other trials in the Division of Preventive Medicine at Mass General Brigham, new research collaborations will be encouraged to use the data collected during this trial. Investigators interested in using data from this trial will be directed to contact the principal investigators for data access.

At all times, we are fully cognizant of and will scrupulously followthe guidelines of the Health Insurance Portability andAccountability Act (HIPAA), to ensure that participants' rights andconfidentiality are not compromised.

IPD Sharing Access Criteria

In year 3, data collection and analysis will be completed for dissemination via scientific poster and oral presentations and manuscript publication in peer-reviewed journals.

In addition, de-identified raw data will be available for up to 5 years at data repositories hosted at the Mass General Brigham Division of Preventive Medicine.

Findings emanating from this project will be shared principally through manuscripts and oral presentations. Results will be disseminated to physicians and other health practitioners through presentations at scientific meetings and by peer-reviewed manuscript publications in medical and research journals. Furthermore, we will post our results on clinicaltrials.gov.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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