Rehabilitation With Empowered STrategies to Optimize REcovery
NCT07406997 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-06-01
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
Conditions
- Lumbar Spine Degenerative Changes
- Lumbar Spine Surgery
Interventions
- 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.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Vanderbilt University Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-24
- Primary Completion
- 2029-02-28
- Completion
- 2029-08-31
Countries
- United States
Study Locations
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