NCT07026305 Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
| NCT ID | NCT07026305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Complutense de Madrid |
| Condition | Lumbar Canal Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-04-21 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Juan P Castaño-Montoya, M.D.,M.Sc.
PRINCIPAL INVESTIGATOR
Universidad Complutense de Madrid
Frequently Asked Questions
Who can join the NCT07026305 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Lumbar Canal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07026305 currently recruiting?
Yes, NCT07026305 is actively recruiting participants. Contact the research team at juanpcas@ucm.es for enrollment information.
Where is the NCT07026305 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07026305 clinical trial?
NCT07026305 is sponsored by Universidad Complutense de Madrid. The principal investigator is Juan P Castaño-Montoya, M.D.,M.Sc. at Universidad Complutense de Madrid. The trial plans to enroll 24 participants.