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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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.
Tripler Army Medical Center
Honolulu, Hawaii, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, United States
Pain Interference
PROMIS Pain Interference domain
Time frame: 3 and 6 months after hospital discharge
Physical Function
PROMIS Physical Function Domain
Time frame: 3 and 6 months after hospital discharge
Disability
Oswestry Disability Index
Time frame: 3 and 6 months after hospital discharge
Pain Intensity
Numeric Rating Scale for back pain and leg pain
Time frame: 3 and 6 months after hospital discharge
Opioid Use
morphine milligram equivalents
Time frame: 3 and 6 months after hospital discharge
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