Status:
COMPLETED
Steroids Versus Gabapentin
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed National Military Medical Center
Brooke Army Medical Center
Conditions:
Sciatica
Radiculopathy
Eligibility:
All Genders
17-100 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain. 142 patients referred to a participating pain c...
Detailed Description
142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to...
Eligibility Criteria
Inclusion
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Numerical Rating Scale leg pain score \> 4 (or if 3/10, greater or equal to back pain)
- MRI evidence of spinal pathology consistent with symptoms
Exclusion
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Leg pain \> 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.
- Pregnancy
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01495923
Start Date
December 1 2011
End Date
September 1 2014
Last Update
April 11 2017
Active Locations (3)
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1
Naval Hospital-San Diego
San Diego, California, United States, 92134
2
Johns Hopkins
Baltimore, Maryland, United States, 21205
3
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889