Actively Recruiting
Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
Led by Universidad Complutense de Madrid · Updated on 2025-06-24
24
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
U
Universidad Complutense de Madrid
Lead Sponsor
H
Hospital San Carlos, Madrid
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the theory of epidural pressure by comparing a surgical procedure that aims to perform less bone resection compared to conventional surgery in patients with lumbar spinal stenosis. The main questions it aims to answer is: Is bony decompression of the lumbar canal performed until normalization of epidural pressure not inferior to conventional surgery in achieving clinical improvement in patients with symptomatic lumbar canal stenosis? Researchers will: Compare conventional open laminectomy to bony decompression of the lumbar canal until normalization of epidural pressure is achieved. Participants will: * Be randomized to one of the two surgical interventions: laminectomy guided by epidural pressure measure or conventional laminectomy. * Visit the clinic for checkups and tests until 1 year of follow-up.
CONDITIONS
Official Title
Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lower back pain and/or lower extremity pain for more than 3 months
- Pain that has not improved with conservative treatments like analgesics, physical therapy, or epidural block
- Neurogenic claudication with a score of 11 or higher on the N-CLASS scale
- Lumbar canal stenosis confirmed by preoperative MRI
- Patient agrees to have the surgery and signs informed consent to participate in the study
You will not qualify if you...
- Foraminal or lateral recess stenosis
- Symptomatic disc herniation at the treated segment
- Spondylolisthesis greater than Grade I (translation over 25%) or spondylolysis
- Radiological instability with more than 5 mm translation on spine X-rays
- Scoliosis with Cobb angle over 30 degrees
- Compression fracture at the treated level
- Previous surgery at the treated segment
- Previous infection at the treated segment
- Contraindication for MRI
- Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
Research Team
J
Juan P Castaño-Montoya, M.D., M.Sc.
CONTACT
A
Angela M Carrascosa-Granada, M.D., M.Sc.,Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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