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Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
This study is currently recruiting participants.
Study NCT00516009   Information provided by Ziv Hospital
First Received: August 13, 2007   No Changes Posted

August 13, 2007
August 13, 2007
August 2007
 
 
 
No Changes Posted
 
 
 
Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Acute low back pain is one of the most common reasons for all physician visits(1). Phospholipase A2 (PLA2), a potent inflammatory mediator, has demonstrated to be released by discs following injury(4). Clinical practice and animal research suggest that lumbar radicular pain is the result of inflammation of the nerve root in the epidural space(5). The study will evaluate the efficacy of intravenous Dexamethasone for acute disc herniation-induced sciatica. 40 patients aged 18 years or older, who will be transferred to the emergency room due to sciatic pain will be blindly randomized to receive Dexamethasone 30 mg IV for 3 days an tapering off, 10 mg daily, or normal saline. 20 patients will be in each group. The patients will continue their standard care during the study period. Follow up will last for 3 months. Mann-Whitney test will be used for parametric correlation, Wilcoxon for numeral and x² for categorial variables. Dexamethasone IV can help physicians in treating patients with acute sciatic pain.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
RADICULAR PAIN
  • Drug: DEXAMETHASONE
  • Other: PLACEBO
  • Experimental: 20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS
  • Placebo Comparator: 20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
July 2008
 

Inclusion Criteria:

  • Patients aged 18 years or older presented with acute radicular pain for less than 6 weeks.

Exclusion Criteria:

  • Patient with acute infection,
  • Psychiatric disorder,
  • Uncontroled diabetes,
  • Uncontrolede hypertension,
  • Severe congestive heart failure,
  • Cauda equina syndrome,
  • Moderate or severe motor deficit,
  • Primary spinal stenosis,
  • Pregnancy.
Both
18 Years to 80 Years
No
Contact: RADI SHAHIEN, MD 972 4 6828928 shahien.r@ziv.health.gov.il
Israel
 
NCT00516009
 
HP-7-247S
Ziv Hospital
 
Principal Investigator: RADI SHAHIEN, MD ZIV MEDICAL CENTER
Ziv Hospital
August 2007

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