Yoga for Persistent Post-Surgical Pain (PPSP)

NCT06949007 | Recruiting DMC

• 2 other identifiers: 2025P0010821K01AT012889-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Feasibility and Acceptability for Aim 1-Enrollment

  ≥ 30% of contacted eligible participants will enroll. Assessment Instrument: REDCap report.

  36 months

• Feasibility and Acceptability for Aim 1-Retention rate

  ≥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

  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)

  ≥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)

  ≥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

  ≥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

  ≥80% of PPSP-related outcome measures will be collected. Assessment instruments: REDCap report for clinical, psychophysical, and biological outcome collection.

  36 months

Secondary Outcomes (8)

• Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups

  48 months

• Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups

  48 months

• Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups

  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)

  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)

  48 months

Study Arms (2)

Yoga group

EXPERIMENTAL

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

Chronic Pain Health Education (CPHE)

ACTIVE COMPARATOR

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

Interventions

Yoga BEHAVIORAL

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.

Also known as: Yoga exercise

Yoga group

Chronic Pain Health Education BEHAVIORAL

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.

Also known as: CPHE

Chronic Pain Health Education (CPHE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (15)

• Osypiuk K, Ligibel J, Giobbie-Hurder A, Vergara-Diaz G, Bonato P, Quinn R, Ng W, Wayne PM. Qigong Mind-Body Exercise as a Biopsychosocial Therapy for Persistent Post-Surgical Pain in Breast Cancer: A Pilot Study. Integr Cancer Ther. 2020 Jan-Dec;19:1534735419893766. doi: 10.1177/1534735419893766.

  PMID: 32009481 BACKGROUND

• Munoz-Vergara D, Grabowska W, Yeh GY, Khalsa SB, Schreiber KL, Huang CA, Zavacki AM, Wayne PM. A systematic review of in vivo stretching regimens on inflammation and its relevance to translational yoga research. PLoS One. 2022 Jun 1;17(6):e0269300. doi: 10.1371/journal.pone.0269300. eCollection 2022.

  PMID: 35648793 BACKGROUND

• Berrueta L, Bergholz J, Munoz D, Muskaj I, Badger GJ, Shukla A, Kim HJ, Zhao JJ, Langevin HM. Stretching Reduces Tumor Growth in a Mouse Breast Cancer Model. Sci Rep. 2018 May 18;8(1):7864. doi: 10.1038/s41598-018-26198-7.

  PMID: 29777149 BACKGROUND

• Berrueta L, Munoz-Vergara D, Martin D, Thompson R, Sansbury BE, Spite M, Badger GJ, Langevin HM. Effect of stretching on inflammation in a subcutaneous carrageenan mouse model analyzed at single-cell resolution. J Cell Physiol. 2023 Dec;238(12):2778-2793. doi: 10.1002/jcp.31133. Epub 2023 Nov 1.

  PMID: 37909412 BACKGROUND

• Schreiber KL, Zinboonyahgoon N, Flowers KM, Hruschak V, Fields KG, Patton ME, Schwartz E, Azizoddin D, Soens M, King T, Partridge A, Pusic A, Golshan M, Edwards RR. Prediction of Persistent Pain Severity and Impact 12 Months After Breast Surgery Using Comprehensive Preoperative Assessment of Biopsychosocial Pain Modulators. Ann Surg Oncol. 2021 Sep;28(9):5015-5038. doi: 10.1245/s10434-020-09479-2. Epub 2021 Jan 15.

  PMID: 33452600 BACKGROUND

• Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.

  PMID: 23290256 BACKGROUND

• Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.

  PMID: 23878604 BACKGROUND

• Munoz-Vergara D, Rist PM, Yang E, Yeh GY, Lee N, Wayne PM. Oxylipin Dynamics Following A Single Bout of Yoga Exercise: A Pilot Randomized Controlled Trial Secondary Analysis. J Integr Complement Med. 2024 Sep;30(9):897-901. doi: 10.1089/jicm.2024.0233. Epub 2024 Jul 15.

  PMID: 39007170 BACKGROUND

• Munoz-Vergara D, Schreiber KL, Langevin H, Yeh GY, Zhu Y, Rist P, Wayne PM. The Effects of a Single Bout of High- or Moderate-Intensity Yoga Exercise on Circulating Inflammatory Mediators: A Pilot Feasibility Study. Glob Adv Health Med. 2022 Dec 11;11:2164957X221145876. doi: 10.1177/2164957X221145876. eCollection 2022.

  PMID: 36583069 BACKGROUND

• Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.

  PMID: 28631003 BACKGROUND

• Muñoz-Vergara D, Burton W, Bain P, et al. Understanding the dynamics of inflammatory mediators in response to mind-body movement therapies (MBMTs): A systematic review and meta-analysis of studies in healthy subjects. Brain Behavior and Immunity Integrative. 2023;2doi:10.1016/j.bbii.2023.100006

  BACKGROUND

• Austin PJ, Moalem-Taylor G. The neuro-immune balance in neuropathic pain: involvement of inflammatory immune cells, immune-like glial cells and cytokines. J Neuroimmunol. 2010 Dec 15;229(1-2):26-50. doi: 10.1016/j.jneuroim.2010.08.013. Epub 2010 Sep 25.

  PMID: 20870295 BACKGROUND

• Osypiuk K, Kilgore K, Ligibel J, Vergara-Diaz G, Bonato P, Wayne PM. "Making Peace with Our Bodies": A Qualitative Analysis of Breast Cancer Survivors' Experiences with Qigong Mind-Body Exercise. J Altern Complement Med. 2020 Sep;26(9):825-832. doi: 10.1089/acm.2019.0406.

  PMID: 32924562 BACKGROUND

• Bower JE, Irwin MR. Mind-body therapies and control of inflammatory biology: A descriptive review. Brain Behav Immun. 2016 Jan;51:1-11. doi: 10.1016/j.bbi.2015.06.012. Epub 2015 Jun 23.

  PMID: 26116436 BACKGROUND

• Chapman CR, Vierck CJ. The Transition of Acute Postoperative Pain to Chronic Pain: An Integrative Overview of Research on Mechanisms. J Pain. 2017 Apr;18(4):359.e1-359.e38. doi: 10.1016/j.jpain.2016.11.004. Epub 2016 Nov 28.

  PMID: 27908839 BACKGROUND

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Dennis Munoz-Vergara, DVM, MS, MPH

CONTACT

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

Peter Wayne, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 29, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• 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.

Locations

US (1)