Understanding and treating chronic pain after surgery in adolescents and adults
Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults
This study is testing if a mindfulness-based workshop can help adolescents and adults with chronic pain after surgery manage their pain better than standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05304286 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the understanding of the neurobiology behind chronic post-surgical pain (CPSP) and develop metrics for tracking patients with CPSP in clinical settings. Participants will be randomized into a workshop based on Acceptance and Commitment Therapy (ACT) or receive Treatment as Usual (TAU). The ACT workshop focuses on mindfulness, acceptance of experiences, identifying personal values, and promoting behavior changes to manage pain. A follow-up booster session will reinforce ACT principles and help participants address challenges in applying the techniques learned.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 and older who have experienced chronic post-surgical pain for at least three months following surgery.
Not a fit: Patients with severe cognitive impairments or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective, personalized treatment strategies for individuals suffering from chronic post-surgical pain.
How similar studies have performed: Previous studies utilizing Acceptance and Commitment Therapy for chronic pain management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: --Females and males aged 12 and older who have previously undergone surgery at least 6 months ago and have chronic post surgical pain (3 months after surgery or longer) Exclusion Criteria: * Inability to speak sufficient English or another language that can be interpreted orally and for questionnaires with the research team * Severe cognitive impairment by history (e.g., intellectual disability, severe head injury) * Patients with significant psychiatric disorders * Use of illegal hard drugs including MDMA, heroin, methamphetimes, amphetamines, cocaine, ketamine, benzodiazepines, and phencyclidine. Absence of such drugs will be confirmed in a urine drug screen during the visit. If prescription medication includes any of these compounds, that medication is not exclusionary.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christine B. Sieberg — Massachusetts General Hospital
- Study coordinator: Christine B Sieberg, PhD
- Email: csieberg@mgh.harvard.edu
- Phone: 6177261654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.