About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pressure-guided laminectomy (PGL)
- Laminectomy without pressure guidance (LWPG)
Treatment groups
Locations
1Sponsors and collaborators
Universidad Complutense de Madrid
Lead sponsor
Hospital San Carlos, Madrid
Collaborator
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Collaborator