NCT07406997

Rehabilitation With Empowered STrategies to Optimize REcovery

Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

The proposed study will conduct a phase II, two-group randomized controlled trial in patients undergoing lumbar spine surgery. Patients will be enrolled and randomized prior to spine surgery from a civilian medical center and military treatment facilities. Patients will be randomized to either (1) 1-session Empowered Relief or (2) 1-session Education. Both interventions are delivered remotely in a group setting through a web-based platform by licensed health care professionals. Outcome assessments will be conducted by evaluators blinded to group assignment at 3-months and 6-months after surgery.The results of our clinical trial will advance research on remote nonpharmacologic strategies for managing pain and improving quality of life post-surgery in both civilian and military patient populations.

Conditions

• Lumbar Spine Degenerative Changes
• Lumbar Spine Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Empowered Relief	Empowered Relief (ER) is a single-session group class that has two main components of pain neuroscience education and pain coping skills based on cognitive-behavioral principles.
OTHER	Education	Education program is a single-session group class that includes information on how to manage pain and disability, prevent future injury and stay healthy after back surgery.

Timeline

• Start date: 2026-02-24
• Primary completion: 2029-02-28
• Completion: 2029-08-31
• First posted: 2026-02-12
• Last updated: 2026-03-27

Locations

4 sites across 1 country: United States