Clinical trial NCT06949007: Yoga for Persistent Post-Surgical Pain (PPSP)
Official title: Yoga for Persistent Post-Surgical Pain (PPSP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Post-surgical Pain
Keywords: Persistent Post-Surgical Pain
Yoga
Randomized Controlled Trial
Chronic Pain Health Education
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility and Acceptability for Aim 1-Enrollment
timeFrame: 36 months
measure: Feasibility and Acceptability for Aim 1-Retention rate
timeFrame: 36 months
measure: Feasibility and Acceptability for Aim 1-Recruitment rate
timeFrame: 36 months
measure: Feasibility and Acceptability for Aim 1-Adherence to interventions (yoga and CPHE)
timeFrame: 36 months
measure: Feasibility and Acceptability for Aim 1-Intervention acceptability (yoga and CPHE)
timeFrame: 36 months
measure: Feasibility and Acceptability for Aim 1-Fidelity
timeFrame: 36 months
measure: Feasibility and Acceptability for Aim 1-Outcome collection
timeFrame: 36 months
Secondary outcomes:
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
timeFrame: 48 months
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
timeFrame: 48 months
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups
timeFrame: 48 months
measure: 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)
timeFrame: 48 months
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Painful After Sensation-PAS)
timeFrame: 48 months
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Pressure Pain Threshold-PPTh)
timeFrame: 48 months
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Pressure Pain Tolerance-PPTo)
timeFrame: 48 months
measure: Exploratory Aim 2-Effect of treatment assignment on PPSP-related biological modulators of PPSP in the yoga and CPHE groups
timeFrame: 48 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
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