Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Not Applicable

• Conditions: RADICULAR PAIN
• Interventions: Drug: DEXAMETHASONE; Other: PLACEBO

• Registration Number: NCT00516009
• Lead Sponsor: Ziv Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Last Update Submitted: 2007-08-13
• Study First Posted: 2007-08-14
• Last Update Posted: 2007-08-14
• Study Completion: 2008-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 TREATMENT GROUP	DEXAMETHASONE	20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS
2	PLACEBO	20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS

Trial Locations

Locations (1)

Neurology Unit - Ziv Mc; 🇮🇱 Safed, Israel