Persistent Post-surgical PainNCT06949007
Yoga for Persistent Post-Surgical Pain (PPSP)
A study testing Yoga and Chronic Pain Health Education in people with Persistent Post-surgical Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Post-surgical Pain
- What is being tested?
- Yoga and Chronic Pain Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02215
Dennis Munoz-Vergara, DVM, MS, MPH
About this study
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.
Read the 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.
- Conditions
- Persistent Post-surgical Pain
- Being tested
- Yoga, Chronic Pain Health Education
- Keywords
- Persistent Post-Surgical Pain, Yoga, Randomized Controlled Trial, Chronic Pain Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called Yoga exercise
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 EducationBehavioural
Also called CPHE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Chronic Pain Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability for Aim 1-Enrollment
≥ 30% of contacted eligible participants will enroll. Assessment Instrument: REDCap report.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
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.
Measured: 48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
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.
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 48 months
Exploratory Aim 2-Effect of treatment assignment on PPSP-related biological modulators of PPSP in the yoga and CPHE groups
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).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start12 Mar 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Persistent Post-surgical PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Dennis Wilson Munoz Vergara, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949007
- Sponsor's protocol ID
- 2025P001082
- Other IDs
- 1K01AT012889-01
- Status last verified
- May 2026
- First submitted
- 14 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32009481Munoz-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.
PubMed 35648793Berrueta 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.
PubMed 29777149Berrueta 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.
PubMed 37909412Schreiber 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.
PubMed 33452600Schreiber 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.
PubMed 23290256Saper 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.
PubMed 23878604Munoz-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.
PubMed 39007170Munoz-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.
PubMed 36583069Saper 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.
PubMed 28631003Munoz-Vergara D, Burton W, Bain P, Rist PM, Khalsa SBS, Schreiber KL, Wayne PM, Yeh GY. 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 Behav Immun Integr. 2023 Apr;2:100006. doi: 10.1016/j.bbii.2023.100006. Epub 2023 Mar 22.
PubMed 42559322Austin 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.
PubMed 20870295Osypiuk 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.
PubMed 32924562Bower 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.
PubMed 26116436Chapman 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.
PubMed 27908839
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Persistent Post-Surgical Pain (PPSP)
- ClinicalTrials.gov ID
- NCT06949007
- Acronym / sponsor ID
- 2025P001082
- Conditions
- Persistent Post-surgical Pain
- Keywords
- Persistent Post-Surgical Pain, Yoga, Randomized Controlled Trial, Chronic Pain Health Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Behavioral: YogaYoga 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. |
| Chronic Pain Health Education (CPHE) | Active comparator | Behavioral: Chronic Pain Health EducationChronic 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaAlso: Yoga exerciseDuration: 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. | Behavioural | Yoga group |
| Chronic Pain Health EducationAlso: CPHEDuration: 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. | Behavioural | Chronic Pain Health Education (CPHE) |
Primary outcome
Feasibility and Acceptability for Aim 1-Enrollment
Time frame: 36 months
≥ 30% of contacted eligible participants will enroll. Assessment Instrument: REDCap report.
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.
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.
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).
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).
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.
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.
8 secondary outcomes
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
Time frame: 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
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
Time frame: 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
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
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
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
Exploratory Aim 2-Effect of treatment assignment on PPSP-related biological modulators of PPSP in the yoga and CPHE groups
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 32009481Osypiuk 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.
- Background: PubMed 35648793Munoz-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.
- Background: PubMed 29777149Berrueta 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.
- Background: PubMed 37909412Berrueta 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.
- Background: PubMed 33452600Schreiber 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.
- Background: PubMed 23290256Schreiber 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.
- Background: PubMed 23878604Saper 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.
- Background: PubMed 39007170Munoz-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.
- Background: PubMed 36583069Munoz-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.
- Background: PubMed 28631003Saper 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.
- Background: PubMed 42559322Munoz-Vergara D, Burton W, Bain P, Rist PM, Khalsa SBS, Schreiber KL, Wayne PM, Yeh GY. 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 Behav Immun Integr. 2023 Apr;2:100006. doi: 10.1016/j.bbii.2023.100006. Epub 2023 Mar 22.
- Background: PubMed 20870295Austin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Chronic Pain Health Education in people with Persistent Post-surgical Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Munoz-Vergara, DVM, MS, MPH (617-278-0917, dmunozvergara@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability for Aim 1-Enrollment (time frame: 36 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06949007, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.