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Lumbar Transforaminal Epidural Dexamethasone

This study has been completed.
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by:
Ahadian, Farshad M., M.D.
ClinicalTrials.gov Identifier:
NCT01303354
First received: February 4, 2011
Last updated: February 23, 2011
Last verified: February 2011

February 4, 2011
February 23, 2011
April 2008
June 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01303354 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Radicular; Neuropathic, Lumbar, Lumbosacral
Procedure: Lumbar Transforaminal Epidural Steroid Injection
  • Experimental: DXM 4 mg
    Dexamethasone 4 mg
    Intervention: Procedure: Lumbar Transforaminal Epidural Steroid Injection
  • Experimental: DXM 8 mg
    Dexamethasone 8 mg
    Intervention: Procedure: Lumbar Transforaminal Epidural Steroid Injection
  • Experimental: DXM 12 mg
    Dexamethasone 12 mg
    Intervention: Procedure: Lumbar Transforaminal Epidural Steroid Injection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01303354
UCSD IRB 080582
No
Farshad M. Ahadian, M.D., Clinical Professor of Anesthesiology, University of California, San Diego
Ahadian, Farshad M., M.D.
San Diego Veterans Healthcare System
Principal Investigator: Farshad M Ahadian, M.D. University of California, San Diego
Ahadian, Farshad M., M.D.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP