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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07411950
Eligibility Criteria:
Inclusion Criteria:
* Age 20-80 years
* Chronic lumbosacral radicular pain persisting ≥ 6 months despite conservative treatment
* Failed back surgery syndrome (FBSS) with history of 1-2 prior lumbar laminectomies or surgery-naïve patients without prior lumbar surgery
* Lower extremity radicular pain with baseline pain intensity ≥ 5 on a 0-10 Numeric Rating Scale
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
* More than two prior lumbar spine surgeries
* Significant spinal pathology other than degenerative disease (e.g., fracture, tumor, infection, inflammatory spondylitis)
* Progressive neurological deficit
* Pregnancy or planned pregnancy during the study period
* Severe systemic illness or contraindication to epidural intervention
* Known allergy to study medications (steroids, hyaluronidase, or saline)
* Inability to complete follow-up assessments
* Any condition judged by investigators to make participation unsafe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07411950
Study Brief:
Protocol Section:
NCT07411950