CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 145 enrolled
Drug / intervention
Gabapentin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01495923
NCT01495923N/ACompleted
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Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy

Johns Hopkins University·interventional·Posted Dec 20, 2011·Updated Apr 11, 2017

In Brief

A clinical study evaluating epidural steroid injection, Sham epidural steroid injection, and 2 other interventions for Sciatica and Radiculopathy. Completed, enrolled 145 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSciatica, Radiculopathy
CountriesUnited States
CollaboratorsWalter Reed National Military Medical Center, Brooke Army Medical Center, Landstuhl Regional Medical Center, Washington D.C. Veterans Affairs Medical Center, United States Naval Medical Center, San Diego, Case Western Reserve University, Milton S. Hershey Medical Center

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionJun 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.5 years ago

Interventions

epidural steroid injectionprocedure

Injection of steroids and local anesthetic into the epidural space

Sham epidural steroid injectionprocedure

Injection of saline into the back muscles

Gabapentindrug

Titration of gabapentin to effect

Placebo gabapentindrug

Titration of placebo gabapentin