Status:
ACTIVE_NOT_RECRUITING
Non-pharmacological Treatment for Pain After Spine Surgery
Lead Sponsor:
Dan Rhon
Collaborating Sponsors:
University of Utah
Madigan Army Medical Center
Conditions:
Low Back Pain
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will b...
Detailed Description
The relevance of our model is supported by evidence that pain catastrophizing, self-efficacy and hypervigilance predict poor surgical outcomes and long-term opioid use. Surgery can exacerbate catastro...
Eligibility Criteria
Inclusion
- Tricare beneficiary receiving care in a participating MHS facility.
- Age 18 - 75 years at the time of enrollment
- Scheduled to undergo lumbar spine surgery within the next 60 days. Surgery may be laminectomy with or without fusions including lateral, transforaminal, posterior or anterior approach for 1-4 lumbar levels. Surgery may be performed in military or civilian facility
- Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis.
- Anticipates ability to attend treatment sessions over a 16 week period following the surgical procedure with no planned absence of 2 weeks or more for training, vacation or any purpose
Exclusion
- Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery.
- A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy
- Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year.
- Contra-indication to participation in post-operative exercise program including severe orthopedic injury limiting mobility, wheelchair dependency, neurological disorder impacting mobility, reliance on supplemental oxygen for daily activity, etc.
- Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2026
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT04770480
Start Date
December 10 2021
End Date
March 30 2026
Last Update
July 3 2025
Active Locations (3)
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1
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
2
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
3
Madigan Army Medical Center
Tacoma, Washington, United States, 98391