NCT06949007 · Brigham and Women's Hospital
Yoga for Persistent Post-Surgical Pain (PPSP)
What this study is about
The overall goal of this project is to complete a pilot feasibility randomly assigned 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Boston, Massachusetts
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations