PREventing Pain After Surgery
Part of paid clinical trials in Chestnut Hill, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT05306665
- Status
- Recruiting
Conditions
- Back Injuries
- Disc Herniation
- Pain, Back
- Spinal Stenosis
- Spondylolisthesis
- Spondylosis
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ACT intervention — BEHAVIORALOne day in person workshop + telephone booster
Study Details
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
Key Dates
- Start date
- Jan 13, 2023
- Status verified
- Oct 2024
- Primary completion
- Aug 1, 2026
- Completion
- Aug 1, 2026
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: ACT interventionParticipants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery
- No Intervention: Treatment As UsualParticipants assigned to this arm will receive treatment as usual.
Primary Outcome Measure
Treatment Helpfulness [ Time Frame: Immediately following the ACT workshop ]
Central Contacts
- Samantha M Meints, PhD6177329014
- Marise Cornelius, MBA
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 01467 |
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