Lumbar Transforaminal Epidural Dexamethasone - Full Text View

Purpose

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.

Condition	Intervention
Radicular; Neuropathic, Lumbar, Lumbosacral	Procedure: Lumbar Transforaminal Epidural Steroid Injection


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial

Resource links provided by NLM:

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Further study details as provided by Ahadian, Farshad M., M.D.:

Primary Outcome Measures:

Radicular Pain Visual Analogue Scale (VAS) Score change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ] [ Designated as safety issue: No ]
Reduction of pain from baseline at each time point.

Secondary Outcome Measures:

Oswestry Disability Index (ODI)- change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ] [ Designated as safety issue: No ]
Improvement of disability level from baseline at each time point
Subject Global Impression of Change (SGIC) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point
Subject Global Satisfaction Scale (SGSS) [ Time Frame: 4 weeks, 8 weeks, 12 weeks post injection ] [ Designated as safety issue: No ]
Allows comparison of Subject Global Satisfaction Scale (SGSS) among groups at each time point
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day of and 1 week post injection ] [ Designated as safety issue: Yes ]
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.


Enrollment:	100
Study Start Date:	April 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303354

Locations


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

Sponsors and Collaborators

Ahadian, Farshad M., M.D.

San Diego Veterans Healthcare System

Investigators


Principal Investigator:	Farshad M Ahadian, M.D.	University of California, San Diego

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Farshad M. Ahadian, M.D., Clinical Professor of Anesthesiology, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT01303354 History of Changes
Other Study ID Numbers:	UCSD IRB 080582
Study First Received:	February 4, 2011
Last Updated:	February 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ahadian, Farshad M., M.D.:


Epidural, Transforaminal, Steroid Injection, Dexamethasone

Additional relevant MeSH terms:


Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016