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Sponsored by: |
Ziv Hospital |
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Information provided by: | Ziv Hospital |
ClinicalTrials.gov Identifier: | NCT00516009 |
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.
Condition | Intervention |
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RADICULAR PAIN |
Drug: DEXAMETHASONE Other: PLACEBO |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica |
Estimated Enrollment: | 40 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
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1 TREATMENT GROUP: Experimental
20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS
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Drug: DEXAMETHASONE |
2: Placebo Comparator
20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS
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Other: PLACEBO |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: RADI SHAHIEN, MD | 972 4 6828928 | shahien.r@ziv.health.gov.il |
Israel | |
Neurology Unit - Ziv Mc | Recruiting |
SAFED, Israel, 13100 | |
Contact: RADI SHAHIEN, MD 972 4 6828928 shahien.r@ziv.health.gov.il | |
Principal Investigator: RADI SHAHIEN, MD |
Principal Investigator: | RADI SHAHIEN, MD | ZIV MEDICAL CENTER |
Study ID Numbers: | HP-7-247S |
Study First Received: | August 13, 2007 |
Last Updated: | August 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00516009 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
RADICULAR PAIN DISC HERNIATION DEXAMETHASONE VAS |
Dexamethasone Sciatica Hernia Pain Dexamethasone acetate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |