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Lumbar Transforaminal Epidural Dexamethasone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303354
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by:
Ahadian, Farshad M., M.D.

Tracking Information
First Submitted Date  ICMJE February 4, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date February 24, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ]
Reduction of pain from baseline at each time point.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • Oswestry Disability Index (ODI)- change from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection ]
    Improvement of disability level from baseline at each time point
  • Subject Global Impression of Change (SGIC) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Transforaminal Epidural Dexamethasone
Official Title  ICMJE Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Radicular; Neuropathic, Lumbar, Lumbosacral
Intervention  ICMJE Procedure: Lumbar Transforaminal Epidural Steroid Injection
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2011)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303354
Other Study ID Numbers  ICMJE UCSD IRB 080582
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farshad M. Ahadian, M.D., Clinical Professor of Anesthesiology, University of California, San Diego
Study Sponsor  ICMJE Ahadian, Farshad M., M.D.
Collaborators  ICMJE San Diego Veterans Healthcare System
Investigators  ICMJE
Principal Investigator: Farshad M Ahadian, M.D. University of California, San Diego
PRS Account Ahadian, Farshad M., M.D.
Verification Date February 2011

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