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:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT00189605
Eligibility Criteria:
Inclusion Criteria:
1. Patient has one symptomatic contained, focal herniated lumbar disc.
2. Patient's age should be at least 18 years old and no more than 75 years old.
3. Selective nerve root injection or epidural steroid injection for symptomatic herniated disc, received between 3 weeks and six months ago.
4. A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
5. Radicular pain concordant with image findings (MRI or CT).
6. Disc height greater than 50%.
7. Patient signs informed consent.
Exclusion Criteria:
1. Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
2. Patient is receiving Worker's compensation or is in litigation related to back/leg pain.
3. Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
4. Allergy to contrast media or drugs to be used in the intended procedure.
5. Medical co-morbidities that preclude surgical intervention.
6. Patient is receiving anti-psychotic therapy.
7. Patient is a prisoner.
8. Patient is incapable of understanding or responding to the study questionnaires.
9. History of previous spinal surgery at, or directly adjacent to, the level to be treated.
10. Patient is morbidly obese (BMI ≥ 40).
11. Patient is simultaneously participating in another device or drug study related to limb/axial pain.
12. Patient has a spinal fracture, tumor or infection.
13. Radicular pain originating from more than one disc level.
14. Axial (back) pain greater than radicular (leg) pain.
15. Clinical evidence of cauda equina syndrome.
16. Progressive neurologic deficit.
17. Radiological evidence of spondylolisthesis at the level to be treated.
18. Radiological evidence of moderate/severe stenosis at the level to be treated.
19. Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00189605
Study Brief:
Protocol Section:
NCT00189605