Lumbar Transforaminal Epidural Dexamethasone

Radicular; Neuropathic, Lumbar, Lumbosacral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303354
• Other study ID #: UCSD IRB 080582
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: February 23, 2011
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: February 2011
• Source: Ahadian, Farshad M., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radicular; Neuropathic, Lumbar, Lumbosacral
• Radiculopathy

Intervention

Procedure:
• Lumbar Transforaminal Epidural Steroid Injection

Locations

Country	Name	City	State
United States	San Diego VA Healthcare System	La Jolla	California
United States	University of California, San Diego - Center for Pain Medicine	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Ahadian, Farshad M., M.D.	San Diego Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes