BridgeMD
New treatment option for Lumbar Canal Stenosis
Official title Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
ClinicalTrials.gov ID: NCT07026305
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.