Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT03495661
Eligibility Criteria:
Inclusion criteria
1. Age 50-85 years.
2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) that indicate and motivate surgery. NRS in lower limbs ≥3.
3. MRI with finding of LSS at 1-3 lumbar levels. Dural sac area ≤ 75 mm² or degree of stenosis C or D according to Schizas classification.
4. The surgical treatment to be provided is decompression alone.
5. The patient has given oral and written informed consent to the participation in the study.
Exclusion criteria
1. Degenerative deformity with Cobb angle \> 20°.
2. Spondylolysis.
3. Symptomatic osteoarthritis in the lower limbs that affects and limits their function.
4. Arterial insufficiency (claudication intermittent) .
5. Past lumbar surgery other than disc hernia.
6. Conditions that affect the spine such as ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), spondylodiscitis/infections, malignancy, neurological diseases.
7. Heart and lung diseases that present a significant risk for surgery or make it impossible for the patient to take part in physical training program (ASA\>3).
8. Polyneuropathies.
9. Psychological factors that make the patient incapable of inclusion in the study (eg drug addiction, dementia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT03495661
Study Brief:
Protocol Section:
NCT03495661