Lumbar Transforaminal Epidural Dexamethasone

Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral
• Intervention / Treatment: Procedure: Lumbar Transforaminal Epidural Steroid Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego - Center for Pain Medicine
    • La Jolla, California, United States, 92161
      • San Diego VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DXM 4 mg; Dexamethasone 4 mg	Procedure: Lumbar Transforaminal Epidural Steroid Injection
Experimental: DXM 8 mg; Dexamethasone 8 mg	Procedure: Lumbar Transforaminal Epidural Steroid Injection
Experimental: DXM 12 mg; Dexamethasone 12 mg	Procedure: Lumbar Transforaminal Epidural Steroid Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline	Reduction of pain from baseline at each time point.	Baseline, 4 weeks, 8 weeks, 12 weeks post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)- change from baseline	Improvement of disability level from baseline at each time point	Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Subject Global Impression of Change (SGIC)	Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point	4 weeks, 8 weeks, 12 weeks
Subject Global Satisfaction Scale (SGSS)	Allows comparison of Subject Global Satisfaction Scale (SGSS) among groups at each time point	4 weeks, 8 weeks, 12 weeks post injection
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	Subjects were specifically assessed for the following adverse events on day-of and one-week post injection: allergic reaction, neurovascular events, pain on injection, paresthesias during the procedure or dysesthesias post procedure, dural puncture, headache, meningismus, neck pain, arm pain, worsening of back pain, worsening of leg pain, facial flusing, mania, insomnia, agitation, hypertension, hyperglycemia. They were also asked to report any other side-effects or complications.	Day of and 1 week post injection

Collaborators and Investigators

• Sponsor: Ahadian, Farshad M., M.D.
• Collaborators: San Diego Veterans Healthcare System
• Investigators: Principal Investigator: Farshad M Ahadian, M.D., University of California, San Diego

Publications and helpful links

General Publications

• Ahadian FM, McGreevy K, Schulteis G. Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Epidural, Transforaminal, Steroid Injection, Dexamethasone
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: UCSD IRB 080582