Rehabilitation With Empowered STrategies to Optimize REcovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empowered Relief, Education.
- Who it may be relevant to
- Registry conditions: Lumbar Spine Degenerative Changes, Lumbar Spine Surgery. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery
Overview
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
Detailed description
The proposed study will conduct a phase II, two-group randomized controlled trial in patients undergoing lumbar spine surgery. Patients will be enrolled and randomized prior to spine surgery from a civilian medical center and military treatment facilities. Patients will be randomized to either (1) 1-session Empowered Relief or (2) 1-session Education. Both interventions are delivered remotely in a group setting through a web-based platform by licensed health care professionals. Outcome assessments will be conducted by evaluators blinded to group assignment at 3-months and 6-months after surgery.The results of our clinical trial will advance research on remote nonpharmacologic strategies for managing pain and improving quality of life post-surgery in both civilian and military patient populations.
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.
Primary outcome measures
- Pain Interference [Time frame: 3 and 6 months after hospital discharge]
Secondary outcome measures (4)
- Physical Function [Time frame: 3 and 6 months after hospital discharge]
- Disability [Time frame: 3 and 6 months after hospital discharge]
- Pain Intensity [Time frame: 3 and 6 months after hospital discharge]
- Opioid Use [Time frame: 3 and 6 months after hospital discharge]
Eligibility criteria
Inclusion criteria
- Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure
- English speaking
- Age between 18-85 years
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Tripler Army Medical Center — Honolulu
- Vanderbilt University Medical Center — Nashville
- Brooke Army Medical Center — Fort Sam Houston
- Madigan Army Medical Center — Joint Base Lewis McChord
Identifiers
NCT: NCT07406997 · 251516 · HT9425-25-1-0925