Completed

Efficacy of Epidural Etanercept in the Treatment of Sciatica

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What is being tested

epidural injection of etanercept

+ placebo (control procedure)

Drug
Who is being recruted

Back Pain+10

+ Nervous System Diseases

+ Neuralgia

From 18 to 70 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: May 2006
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2006

Actual date on which the first participant was enrolled.

As per the wishes of the Dept. of the Army and Walter Reed Army Medical Center Dept. of Clinical Investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanercept or saline injections at 2-week intervals. Both patients and physicians will be blinded as to the injectate and treatment group. There will be 3 study groups. Group I will receive either 2 mg of etanercept or saline per injection. Group II will receive either 4 mg of etanercept or saline per injection. Group III will receive either 6 mg of etanercept or saline per injection. In each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. As per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.

Official TitleEfficacy of Epidural Etanercept in the Treatment of Sciatica
NCT00364572
Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesPainPeripheral Nervous System DiseasesSciaticaSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back PainMononeuropathiesSciatic Neuropathy

Criteria

4 inclusion criteria required to participate
Chronic low back pain of radicular origin of > 2 months but < 1 year duration.
Failure of conservative therapy to include physical and pharmacotherapy.
MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.
Normal white blood cell count (drawn in 1 blood vial).
8 exclusion criteria prevent from participating
Uncontrolled coagulopathy.
Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.
Allergy to contrast dye.
Unstable medical condition (e.g., unstable angina or congestive heart failure).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Two injections of epidural etanercept 2 weeks apart

Group II

Placebo
Two injections of epidural saline 2 weeks apart

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Walter Reed Army Medical Center

Washington D.C., United StatesOpen Walter Reed Army Medical Center in Google Maps
CompletedOne Study Center