Treatment options for lumbar spinal stenosis using a new non-surgical method
Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial
This study is testing a new non-surgical treatment for lumbar spinal stenosis to see if it can help people feel better compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05527145 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a percutaneous interspinous spacer as a non-surgical treatment for symptomatic lumbar spinal stenosis compared to traditional surgical methods. A total of 200 patients aged 50-85 will be randomly assigned to either a surgical group, which will receive decompression surgery, or a non-surgical group, which will undergo the new spacer insertion technique. The primary outcome will be measured using the Oswestry Disability Index, while secondary outcomes will include nerve conduction studies and patient-reported measures. The goal is to determine if the non-surgical approach can provide similar or better outcomes than surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-85 with clinical symptoms of lumbar spinal stenosis and MRI findings supporting the diagnosis.
Not a fit: Patients with significant degenerative deformities, prior lumbar surgeries, or other serious spinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option for patients suffering from lumbar spinal stenosis, potentially improving their quality of life.
How similar studies have performed: While there have been studies on surgical treatments for lumbar stenosis, the specific non-surgical approach being tested in this trial is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 50-85 years. 2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3. 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 4. The patient has given oral and written informed consent to participate. Exclusion Criteria: 1. Degenerative deformity with Cobb angle \>20°. 2. Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function. 3. Arterial insufficiency (claudication intermittent). 4. Former lumbar surgery other than disc hernia. 5. Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases. 6. Heart and lung diseases presenting a significant risk for surgery or making it impossible for the patient to take part in a percutaneous arm of treatment (American Society of Anesthesiologists (ASA) score \>3). 7. Polyneuropathies. 8. Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).
Where this trial is running
Rome
- Sapienza University of Rome, Policlinico Umberto I Hospital — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro napoli, md, phd
- Email: alessandro.napoli@uniroma1.it
- Phone: +390649974521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.