Steroids Versus Gabapentin
Completed · Not applicable · Has a placebo group
Conditions studied: Sciatica, Radiculopathy
In brief
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 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 receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients \& evaluating physicians will be blinded. Follow-up will be through 3-months after treatment.
Key facts
- Study ID
- NCT01495923
- Run by
- Johns Hopkins University
- People needed
- 145
- Starts
- 2011-12-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2017-04-11
Who can join
Age: 17 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Naval Hospital-San Diego — San Diego, California, United States
- Johns Hopkins — Baltimore, Maryland, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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