Status:
COMPLETED
Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Collaborating Sponsors:
Charlotte Surgery Center
Conditions:
Pain, Radiating
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relati...
Detailed Description
Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relati...
Eligibility Criteria
Inclusion
- 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
- History of
- acute trauma,
- diabetes (type I or type II),
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02226159
Start Date
August 1 2014
End Date
December 31 2024
Last Update
August 11 2025
Active Locations (1)
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1
OrthoCarolina
Charlotte, North Carolina, United States, 28207