Yoga for Persistent Post-Surgical Pain (PPSP)
- Conditions
- Persistent Post-surgical Pain
- Registration Number
- NCT06949007
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility and Acceptability for Aim 1-Enrollment 36 months ≥ 30% of contacted eligible participants will enroll. Assessment Instrument: REDCap report.
Feasibility and Acceptability for Aim 1-Retention rate 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 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) 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) 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 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 36 months ≥80% of PPSP-related outcome measures will be collected.
Assessment instruments: REDCap report for clinical, psychophysical, and biological outcome collection.
- Secondary Outcome Measures
Name Time Method Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychosocial modulators of PPSP in the yoga and CPHE groups 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.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 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).
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 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).
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Pressure Pain Threshold-PPTh) 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).
Exploratory Aim 2-Effect of treatment assignment on PPSP-related psychophysical modulators of PPSP in the yoga and CPHE groups (Pressure Pain Tolerance-PPTo) 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).
Exploratory Aim 2-Effect of treatment assignment on PPSP-related biological modulators of PPSP in the yoga and CPHE groups 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).
Trial Locations
- Locations (1)
Mass General Brigham
🇺🇸Boston, Massachusetts, United States