Overview

Steroids Versus Gabapentin

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Brooke Army Medical Center
Case Western Reserve University
DC VA Hospital
Landstuhl Regional Medical Center
Milton S. Hershey Medical Center
United States Naval Medical Center, San Diego
Walter Reed National Military Medical Center
Washington D.C. Veterans Affairs Medical Center
Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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