Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis? (NCT07026305) | Clinical Trial Compass
RecruitingNot Applicable
Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
Spain24 participantsStarted 2025-04-21
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.