NCT06949007

Yoga for Persistent Post-Surgical Pain (PPSP)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Post-surgical Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-09-30
• Completion: 2029-06-30
• First posted: 2025-04-29
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States