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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02525120
Eligibility Criteria:
Inclusion Criteria
1. Patient is willing to provide informed consent.
2. Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S1.
3. The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.
4. The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.
5. The patient must have pain in a dermatomal distribution consistent with their radiographic findings
6. Leg pain greater than or equal to 5 on the NRS scale
7. Symptoms for at least 6 weeks
8. Willingness to complete all follow-up evaluations
9. Patient aged 18-65 years
10. BMI\<40
Exclusion Criteria:
1. Patients with a disc herniation extending past the facet joint
2. Presence of a non-contiguous disc fragment
3. Impairment of bladder/bowel function or motor impairment in the affected leg
4. An epidural steroid injection in the past 2 weeks
5. Previous discectomy, arthroplasty or fusion at any lumbar level
6. In patients with L5-S1 disc herniation, a congenital condition where the L5 vertebral body is either fused to the sacrum or the L5-S1 disc is not fully formed as a normal adult disc.
7. Symptomatic lumbar stenosis or listhesis
8. Symptomatic sacroiliac joint
9. Symptomatic foraminal stenosis due to severe degenerative disc disease
10. History of spinal tumor, fracture or infection
11. Females of childbearing age that are known to be pregnant or wishing to become pregnant during the study
12. Fibromyalgia
13. Active infection
14. Metastatic cancer within the past 5 years
15. Pending litigation against a health care provider
16. More than 3 months of continuous sick leave prior to enrollment.
17. Known drug or alcohol abuse
18. Diagnosed psychiatric disease or psychological distress caused by recent trauma like divorce, death of a member family or loss of a job
19. Patient known to be affected by favism (G6PD deficiency)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02525120
Study Brief:
Protocol Section:
NCT02525120