About this trial
Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50-85 years.
Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3.
MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75 mm2 or degree of stenosis C or D according to Schizas's classification.34
The patient has given oral and written informed consent to participate.
Disqualifiers
Degenerative deformity with Cobb angle >20°.
Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
Arterial insufficiency (claudication intermittent).
Former lumbar surgery other than disc hernia.
Trial design
Crossover
Treatments tested in this trial
Minimally invasive surgery
Procedure/SurgerySurgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.
Percutaneous Spacer
Procedure/Surgerypercutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion
Treatment groups
Trial outcomes
Primary outcomes
oswestry disability Index
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
oswestry disability Index
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
Secondary outcomes
Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)
Numeric Rating Scale (NRS)
for low back and leg pain (0-10 being 10 worst)
subjective walking ability tool
neurophysiological measurements (NCSs/EMG)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.