Rehabilitation With Empowered STrategies to Optimize REcovery
RESTORE
2 other identifiers
interventional
100
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedStudy Start
First participant enrolled
February 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
August 20, 2026
March 1, 2026
3 years
February 5, 2026
August 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Interference
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (T-score metric), higher scores indicate greater pain interference
3 and 6 months after hospital discharge
Secondary Outcomes (4)
Physical Function
3 and 6 months after hospital discharge
Disability
3 and 6 months after hospital discharge
Pain Intensity
3 and 6 months after hospital discharge
Opioid Use
3 and 6 months after hospital discharge
Other Outcomes (4)
Pain Catastrophizing
3 and 6 months after hospital discharge
Sleep
3 and 6 months after hospital discharge
Patient Satisfaction
3 and 6 months after hospital discharge
- +1 more other outcomes
Study Arms (2)
Empowered Relief
EXPERIMENTALRemotely delivered group session with behavioral strategies
Education
ACTIVE COMPARATORRemotely delivered group session with educational information
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Surgical treatment of a lumbar degenerative condition using a laminectomy and/or fusion procedure
- English speaking
- Age between 18-85 years
You may not qualify if:
- 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
- Currently undergoing treatment for cancer
- Unable to access a reliable internet connection
- Unable to provide a stable telephone or physical address
- Unable to participate in follow-up assessment for 6 months after surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, 98431, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 5, 2026
First Posted
February 12, 2026
Study Start
February 24, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
August 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share