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A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

NCT00733096 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2012-10-08

Study results available
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Summary

Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural etanercept, the results showed significant benefit in favor of the etanercept group, but no subject was included with a duration of pain \> 9 months, and the results of this study have yet to be replicated.

Currently, epidural steroid injections are the most frequently performed procedures in pain clinics across the U.S. However, epidural steroids may benefit only a select group of patients. The literature on treating sciatica is notable for a lack of randomized comparative studies involving various treatments. The objective of this project is to conduct a 3-arm study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2) transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.

Conditions

  • Lumbosacral Radiculopathy

Interventions

DRUG

etanercept

Two transforaminal epidural injections of 4 mg, two weeks apart

DRUG

methylprednisolone

Two transforaminal epidural steroid injections with 60 mg, two weeks apart

DRUG

normal saline

Two transforaminal epidural saline injections, two weeks apart

Sponsors & Collaborators

  • Walter Reed Army Medical Center

    collaborator FED

  • National Naval Medical Center

    collaborator FED

  • Womack Army Medical Center

    collaborator FED

  • Landstuhl Regional Medical Center

    collaborator FED

  • Massachusetts General Hospital

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00733096 on ClinicalTrials.gov