Yoga for Persistent Post-Surgical Pain (PPSP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility and Acceptability for Aim 1-Enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Yoga group
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.
干预措施: Yoga (Behavioral)
Chronic Pain Health Education (CPHE)
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).
干预措施: Chronic Pain Health Education (Behavioral)
结局指标
主要结局
Feasibility and Acceptability for Aim 1-Enrollment
时间窗: 36 months
≥ 30% of contacted eligible participants will enroll. Assessment Instrument: REDCap report.
Feasibility and Acceptability for Aim 1-Retention rate
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 36 months
≥80% of PPSP-related outcome measures will be collected. Assessment instruments: REDCap report for clinical, psychophysical, and biological outcome collection.
次要结局
- 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)
- 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)
- 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)
- Exploratory Aim 2-Effect of treatment assignment on PPSP-related biological modulators of PPSP in the yoga and CPHE groups(48 months)
研究者
Dennis Wilson Munoz Vergara
Instructor of Medicine
Brigham and Women's Hospital