Actively Recruiting
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
Led by University of Roma La Sapienza · Updated on 2024-02-12
200
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 85 years
- Clinical symptoms of lumbar spinal stenosis with leg pain (Numeric Rating Scale 653)
- MRI confirming lumbar spinal stenosis at 1 to 3 levels with dural sac area 6475 mm2 or severe stenosis by Schizas's classification
- Oral and written informed consent given to participate
You will not qualify if you...
- Degenerative spinal deformity with Cobb angle greater than 20 degrees
- Symptomatic osteoarthritis in lower limbs limiting function
- Arterial insufficiency causing intermittent claudication
- Prior lumbar surgery except for disc hernia
- Spine conditions like ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spinal infections, malignancy, or neurological diseases
- Heart or lung disease posing significant surgical risk or preventing participation in non-surgical treatment (ASA score greater than 3)
- Polyneuropathies
- Psychological conditions such as drug addiction or dementia that prevent trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sapienza University of Rome, Policlinico Umberto I Hospital
Rome, Italy
Actively Recruiting
Research Team
A
Alessandro napoli, md, phd
CONTACT
S
silvia ciotti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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