Empowered Relief to improve recovery after lumbar spine surgery
Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery
This project will test if a single remote Empowered Relief session helps adults 18–75 recover better after lumbar spine surgery than a single remote education session.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 4 sites (Honolulu, Hawaii and 3 other locations) |
| Trial ID | NCT07406997 on ClinicalTrials.gov |
What this trial studies
This is a phase II, two-group randomized controlled trial enrolling adults undergoing lumbar laminectomy with or without fusion for degenerative conditions at civilian and military medical centers. Participants are randomized before surgery to one remotely delivered group session of Empowered Relief or a remotely delivered group education session, both led by licensed clinicians. Outcomes are measured with patient-reported surveys before surgery and at 3 and 6 months after surgery, with evaluators blinded to group assignment. The trial will examine postoperative pain, function, and pain catastrophizing to see whether the brief behavioral intervention improves recovery.
Who should consider this trial
Good fit: Adults aged 18–75 who are English-speaking, scheduled for primary lumbar laminectomy (with or without fusion) for degenerative disease, and able to access reliable internet and complete 6-month follow-up are ideal candidates.
Not a fit: Patients undergoing revision surgery, surgery for trauma/fracture/tumor/infection/deformity, those with recent prior lumbar surgery, active cancer treatment, ongoing litigation/workers' compensation claims, or without reliable internet/follow-up ability are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this remote single-session program could reduce postoperative pain and disability and improve quality of life after lumbar spine surgery using a low-cost, scalable approach.
How similar studies have performed: Brief single-session behavioral interventions like Empowered Relief and other remote pain-management programs have shown promising reductions in pain catastrophizing and symptom measures in some surgical and chronic pain populations, but evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure * English speaking * Age between 18-75 years Exclusion Criteria: * Surgery due to trauma, fracture, tumor, infection, or spinal deformity * Revision surgery * Prior history of lumbar spine surgery in last 5 years * Involved in litigation or a workers' compensation claim due to injury * Currently undergoing treatment for cancer * Unable to access a reliable internet connection * Unable to provide a stable telephone or physical address * Unable to participate in follow-up assessment for 6 months after surgery
Where this trial is running
Honolulu, Hawaii and 3 other locations
- Tripler Army Medical Center — Honolulu, Hawaii, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States (Not_yet_recruiting)
- Madigan Army Medical Center — Joint Base Lewis McChord, Washington, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Kristin Archer, PhD
- Email: kristin.archer@vumc.org
- Phone: 615-322-2732
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.