Empowered Relief for Back Surgery
(RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for individuals with pancreatic cancer or lumbar spine degeneration who are undergoing lumbar spine surgery. Participants must be willing to complete a group session of Empowered Relief or Education after their surgery and fill out surveys before, as well as 3 and 6 months post-surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants complete surveys before surgery to assess baseline pain and functional status
Treatment
Participants receive one group session of remotely delivered Empowered Relief or Education after back surgery
Follow-up
Participants are monitored for pain interference, physical function, disability, pain intensity, opioid use, pain catastrophizing, sleep disturbance, patient satisfaction, and employment status at 3 and 6 months after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Empowered Relief
Trial Overview
The study tests if a behavioral intervention called Empowered Relief can improve recovery when performed soon after back surgery, compared to standard education. It examines the effect on pain management and functional limitations through remote sessions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Remotely delivered group session with behavioral strategies
Remotely delivered group session with educational information
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
United States Department of Defense
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.