Lumbar Transforaminal Epidural Dexamethasone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-06-30

Brief Summary

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The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.

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Detailed Description

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Transforaminal epidural steroid injections (TFESI) have been demonstrated to be an effective treatment for radicular pain. Over the last decade, rare but serious complications have been reported following transforaminal epidural steroid injections (TFESI). Recent research indicates that certain types of corticosteroids containing microscopic particles may be responsible for these adverse events. Dexamethasone (DXM) is a non-particulate cortico-steroid that has not been implicated in these adverse events. However, there is inadequate evidence up to date to support the use of Dexamethasone (DXM) for transforaminal epidural steroid injections (TFESI). This study aims to bridge that gap.

Conditions

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Radicular; Neuropathic, Lumbar, Lumbosacral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DXM 4 mg

Dexamethasone 4 mg

Group Type EXPERIMENTAL

Lumbar Transforaminal Epidural Steroid Injection

Intervention Type PROCEDURE

DXM 8 mg

Dexamethasone 8 mg

Group Type EXPERIMENTAL

Lumbar Transforaminal Epidural Steroid Injection

Intervention Type PROCEDURE

DXM 12 mg

Dexamethasone 12 mg

Group Type EXPERIMENTAL

Lumbar Transforaminal Epidural Steroid Injection

Intervention Type PROCEDURE

Interventions

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Lumbar Transforaminal Epidural Steroid Injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI

Exclusion Criteria

* pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No