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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT02441959
Eligibility Criteria:
Inclusion Criteria:
1. Patient equal to or greater than 18 years old.
2. Patients with single level para-central herniated discs from L1-S1.
3. VAS (Visual Analog Scale) leg \> 40 mm.
4. Leg pain must be greater than back pain.
5. Minimum 6 weeks conservative treatment unless motor strength U\< U4/5 and or deteriorating neurologic function.
Exclusion Criteria:
1. Lateral/subarticular, far lateral disc herniations
2. Multi-focal (multi modal) disc herniations
3. Symptomatic multiple level disc herniations
4. Active infection either spinal or otherwise
5. Prior history of lumbar spinal infection at any level
6. Spinal tumor in lumbar region
7. Dynamic (any grade) or fixed spondylolisthesis more than 3mm
8. Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level
9. Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
10. Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
11. Disc herniation which is significantly calcified
12. Contra-lateral leg pain U\>40 mm
13. History of peripheral diabetic neuropathy
14. Significant central stenosis with history of neurogenic claudication
15. Pregnancy
16. Facet cyst on symptomatic side
17. Cauda Equina syndrome past or present
18. Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.
19. Significant vascular claudication
20. History of radiation to the spinal column
21. History of malignancy of any type within 2 years of consideration of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02441959
Study Brief:
Protocol Section:
NCT02441959