Steroids Versus Gabapentin

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.

Conditions

• Sciatica
• Radiculopathy

Interventions

PROCEDURE

epidural steroid injection

Injection of steroids and local anesthetic into the epidural space

PROCEDURE

Sham epidural steroid injection

Injection of saline into the back muscles

DRUG

Gabapentin

Titration of gabapentin to effect

DRUG

Placebo gabapentin

Titration of placebo gabapentin

Sponsors & Collaborators

• Walter Reed National Military Medical Center

  collaborator FED

• Brooke Army Medical Center

  collaborator FED

• Landstuhl Regional Medical Center

  collaborator FED

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• United States Naval Medical Center, San Diego

  collaborator FED

• Case Western Reserve University

  collaborator OTHER

• Milton S. Hershey Medical Center

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Steven P Cohen, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

17 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2014-06-30

Completion

2014-09-30

Countries

• United States

Study Locations