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| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2007 | ||||
| Last Updated Date | August 13, 2007 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica | ||||
| Official Title ICMJE | Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | RADICULAR PAIN | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | July 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00516009 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | HP-7-247S | ||||
| Study Sponsor ICMJE | Ziv Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Ziv Hospital | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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