NCT07406997 Rehabilitation With Empowered STrategies to Optimize REcovery
| NCT ID | NCT07406997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Lumbar Spine Degenerative Changes |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-02-24 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main goal of this clinical trial is to understand the benefits of remotely delivered Empowered Relief in patients undergoing lumbar spine surgery. The main question the trial aims to answer is: Does a postoperative behavioral intervention, Empowered Relief, performed early after back surgery have a measurable impact on postoperative outcomes? Additional questions are whether changes in pain catastrophizing are related to improvements in outcomes and whether preoperative pain catastrophizing is a moderator of response to treatment. Researchers will compare remotely delivered Empowered Relief to remotely delivered education to see if Empowered Relief helps patients manage their pain and functional limitations after back surgery. Participants will: * Complete one group session of remotely delivered Empowered Relief or Education after back surgery * Complete surveys before surgery and 3- and 6-months after surgery
Eligibility Criteria
Inclusion Criteria: * Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure * English speaking * Age between 18-85 years Exclusion Criteria: * Surgery due to trauma, fracture, tumor, infection, or spinal deformity * Revision surgery * Prior history of lumbar spine surgery in last 12 months * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07406997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Lumbar Spine Degenerative Changes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07406997 currently recruiting?
Yes, NCT07406997 is actively recruiting participants. Contact the research team at kristin.archer@vumc.org for enrollment information.
Where is the NCT07406997 trial being conducted?
This trial is being conducted at Honolulu, United States, Nashville, United States, Fort Sam Houston, United States, Joint Base Lewis McChord, United States.
Who is sponsoring the NCT07406997 clinical trial?
NCT07406997 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 100 participants.