Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversidad Complutense de Madrid
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pressure-guided laminectomy (PGL)
Procedure/SurgeryOsseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.
Laminectomy without pressure guidance (LWPG)
Procedure/SurgeryComplete resection of both the lamina and the ligamentum flavum at the stenotic segment.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Pressure-guided laminectomy (PGL)Experimental treatment 1 intervention
Group B: Non-pressure-guided laminectomy (NPGL)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Zurich Claudication Questionnaire (ZCQ) - Symptom Severity subcategory.
This scale consists of 7 items that evaluate the severity of symptoms over the last month on a numeric scale from 1 to 5, where 5 represents greater severity. A mean score of the items is calculated.
Time frame
At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.Secondary outcomes
1
Zurich Claudication Questionnaire (ZCQ) - Physical Function subcategory.
Consists of 5 items evaluating functional impairment over the last month on a numeric scale from 1 to 4, where 4 represents greater disability. A mean score of the items is calculated.
Time frame
At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.2
Zurich Claudication Questionnaire (ZCQ) - Patient Satisfaction subcategory.
Consists of 5 items, classified into 4 categories (from very satisfied to very dissatisfied), assessing overall outcome, pain relief, walking ability, ability to work or do house/garden chores, and strength and balance. This subcategory is assessed at 6 months and 1 year post-surgery.
Time frame
At enrollment and at the follow-up visits at 6 and 12 months post-surgery.3
Numeric Pain Rating Scale (NPRS).
A pain measurement scale where patients rate their pain on an 11-point scale from 0 to 10, with 0 (far left) representing "no pain" and 10 (far right) representing "worst imaginable pain." This will be evaluated for both lower extremity symptoms (NPRS for legs) and for lower back/gluteal pain (NPRS for back or buttock).
Time frame
At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.4
Oswestry Disability Index (ODI).
Assesses disability associated with pain across 10 items, each scored from 0 (no disability) to 5 (severely affected). The result is a percentage score calculated as the sum of item scores divided by the total possible points, multiplied by 100. Disability is classified as minimal (0-20%), moderate (21-40%), severe (41-60%), crippled (61-80%), or bed-bound/exaggeration (\>80%).
Time frame
At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Complutense de Madrid
Lead sponsor
Hospital San Carlos, Madrid
Collaborator
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Collaborator
Source ClinicalTrials.gov