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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT04254250
Eligibility Criteria:
Inclusion Criteria:
\- Age 18 to 60 years;
Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;
1. Radicular leg pain with or without back pain;
2. Symptoms persisting for at least four weeks prior to surgery;
3. Given written Informed Consent;
4. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
5. Visual Analogue Scale score at least 40/100 at baseline.
Exclusion Criteria:
1. More than one symptomatic level requiring multilevel surgical decompression
2. Stenosis any etiology at the same level;
3. Spondylolisthesis any etiology at the same level;
4. Prior lumbar spinal surgery at any level;
5. Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
6. Concurrent participation in another clinical study that may confound study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04254250
Study Brief:
Protocol Section:
NCT04254250