Status:
COMPLETED
Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Cervical Radiculopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundre...
Eligibility Criteria
Inclusion
- Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
- NRS arm pain score \> 3
- MRI evidence of disc pathology consistent with symptoms
Exclusion
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Arm pain \> 4 years duration
- Epidural steroid injection within past 3 years
- Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
- Signs or symptoms or myelopathy or spinal cord compression
- Previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline
- Allergic reactions to gabapentin or nortriptyline
- Referrals from surgery for diagnostic injections for surgical evaluation
- Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
- Pregnancy
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01144923
Start Date
June 1 2010
End Date
November 1 2013
Last Update
April 24 2014
Active Locations (2)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
2
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205