Lumbar Transforaminal Epidural Dexamethasone

Ahadian, Farshad M., M.D.

Status: Completed

Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral

Treatments: Procedure: Lumbar Transforaminal Epidural Steroid Injection

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01303354

UCSD IRB 080582

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups

DXM 4 mg

Experimental group

Description:

Dexamethasone 4 mg

Treatment:

Procedure: Lumbar Transforaminal Epidural Steroid Injection

DXM 8 mg

Experimental group

Description:

Dexamethasone 8 mg

Treatment:

Procedure: Lumbar Transforaminal Epidural Steroid Injection

DXM 12 mg

Experimental group

Description:

Dexamethasone 12 mg

Treatment:

Procedure: Lumbar Transforaminal Epidural Steroid Injection