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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT03801356
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-80
* Diagnosis of unilateral lower extremity radiculopathy due to degenerative foraminal stenosis
* Patients scheduled for an associated lumbar foraminotomy procedure
* Diagnosis of radiculopathy with imaging and/or clinical history or physical exam that does not demonstrate a clear neurogenic source of their pain
* Subjects must be available for the entire study duration (12 months)
Exclusion Criteria:
* Patients will be excluded if there is a clear correlation between imaging and radiculopathy
* Radiculopathy associated with trauma, tumor or infection. Non-radicular lower extremity pain will also be excluded
* Patients who cannot tolerate the SNRB without IV sedation
* Surgery requiring multi-level decompression and/or fusion
* Surgical indication for malignancy, injection or acute or emergency trauma
* History of major surgery within 3 months prior to enrollment
* Pregnant females
* Presence of severe acute, chronic medical or psychiatric condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03801356
Study Brief:
Protocol Section:
NCT03801356