Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?

Recruiting now · Not applicable

Conditions studied: Lumbar Canal Stenosis, Lumbar Spinal Stenosis, Lumbar Spinal Stenosis (LSS)

In brief

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.

Key facts

Study ID

NCT07026305

Run by

Universidad Complutense de Madrid

People needed

24

Starts

2025-04-21

Expected to finish

2026-10-01

Last updated by the study team

2025-06-24

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Surgical indication determined by:
• Lower back pain and/or lower extremity pain for more than 3 months.
• Pain refractory to conservative medical management (analgesics, physical therapy, epidural block).
• Clinical criterion of neurogenic claudication defined as a score ≥11 on the N-CLASS scale.
• Preoperative magnetic resonance imaging (MRI) showing lumbar canal stenosis.
• Patient consents to the proposed surgical intervention.
• Patient agrees to participate in the study by signing the informed consent form.

You may not qualify if…

• Foraminal or lateral recess stenosis.
• Symptomatic disc herniation at the segment to be treated.
• Spondylolisthesis > Grade I (Meyerding) (translation >25% of the vertebra) or spondylolysis.
• Radiological instability defined as >5 mm of anteroposterior translation on dynamic flexion-extension spine X-rays.
• Scoliosis with Cobb angle >30°.
• Compression fracture at the level to be treated.
• Prior surgery at the same segment to be treated.
• Prior infection at the segment to be treated.
• Contraindication for MRI.
• Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria.

Where it is running

• Hospital Clínico San Carlos — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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