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

RecruitingNAAges 50 Years - anyAllUniversidad Complutense de Madrid
NCT07026305 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Pressure-guided laminectomy (PGL)
  • Laminectomy without pressure guidance (LWPG)
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Where

1 site
Hospital Clínico San Carlos
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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