Rehabilitation With Empowered STrategies to Optimize REcovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVanderbilt University Medical Center
About 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
Eligibility criteria
Qualifiers
Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure
English speaking
Age between 18-85 years
Disqualifiers
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
Trial design
Treatments tested in this trial
- Empowered Relief
- Education
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov