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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02226159
Eligibility Criteria:
Inclusion Criteria:
* Subjects who have cervical radicular pain without significant neurologic deficit (neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT findings of neural compression (neural compression is defined as disc herniation or central or foraminal spinal stenosis),
* Failed 6 weeks of conservative treatment (conservative treatment is defined as relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or analgesic medications),
* Deemed to be good operative candidates by spine surgeons (patients with MRI/CT findings of neural compression with concordant symptoms) and had agreed to possible operative intervention
Exclusion Criteria:
* History of
1. acute trauma,
2. diabetes (type I or type II),
3. active infection
* Active progressive neurological deficit (neurologic is deficit defined as manual muscle testing less than 3/5),
* Medical condition that may affect the cervical spine neurological exam and/or pain assessment (e.g. peripheral neuropathy),
* Bilateral disease,
* More than one cervical level requiring injection,
* Bleeding disorders or other medical contraindications to the injection procedure,
* Absence of substantial radicular pain (radicular pain is defined as arm pain greater than neck pain),
* Involvement in workers' compensation claim, or any litigation related to neck injury.
* Patients who are pregnant, or who plan to become pregnant in the next 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02226159
Study Brief:
Protocol Section:
NCT02226159