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
This trial does not accept healthy volunteersQualifiers
Surgical treatment of a lumbar degenerative condition using a laminectomy and/or 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
Design model
Parallel
Treatments tested in this trial
Empowered Relief
BehavioralEmpowered 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.
Education
Other interventionEducation 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Empowered ReliefExperimental treatment 1 intervention
Group B: EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Interference
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (T-score metric), higher scores indicate greater pain interference
Time frame
3 and 6 months after hospital dischargeSecondary outcomes
1
Physical Function
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (T-score metric), higher scores indicate better physical function
Time frame
3 and 6 months after hospital discharge2
Disability
Oswestry Disability Index (0-100%), higher percentages indicate greater impairment
Time frame
3 and 6 months after hospital discharge3
Pain Intensity
Numeric Rating Scale for back pain and leg pain (0-10), higher scores indicate greater pain intensity
Time frame
3 and 6 months after hospital discharge4
Opioid Use
morphine milligram equivalents
Time frame
3 and 6 months after hospital dischargeOther outcomes
1
Pain Catastrophizing
Pain Catastrophizing Scale (0-51), higher scores indicate higher levels of pain-related, catastrophic thinking
Time frame
3 and 6 months after hospital discharge2
Sleep
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (T-score metric), higher scores indicate more severe sleep disturbance
Time frame
3 and 6 months after hospital discharge3
Patient Satisfaction
NASS Patient Satisfaction Index (4-point scale), higher scores indicate being less satisfied
Time frame
3 and 6 months after hospital discharge4
Employment
Return to work or duty (yes or no) and date of return
Time frame
3 and 6 months after hospital dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov