Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 TREATMENT GROUP 20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS |
Drug: DEXAMETHASONE
|
| Placebo Comparator: 2 20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS |
Other: PLACEBO
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
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,
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Severe congestive heart failure,
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Cauda equina syndrome,
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Moderate or severe motor deficit,
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Primary spinal stenosis,
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Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neurology Unit - Ziv Mc | Safed | Israel | 13100 |
Sponsors and Collaborators
- Ziv Hospital
Investigators
- Principal Investigator: RADI SHAHIEN, MD, Ziv Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Atul TP and Abna AO. Diagnosis and Management of Acute Low Back Pain. American Family Physician. Published by The American Academy of Family Physicians, March 15, 2000.
- Boqing C and Patrick M. Epidural Steroid Injections. August 11, 2005; www.emedicine.com.
- Engstrom JW. Back and neck pain. In: Kasper DL, Braunwald E, Fauci A, et al, eds. Harrison's Principles of Internal Medicine. 16th ed. New York: McGraw-Hill; 2005: 94-104.
- Finckh A, Zufferey P, Schurch MA, Balagué F, Waldburger M, So AK. Short-term efficacy of intravenous pulse glucocorticoids in acute discogenic sciatica. A randomized controlled trial. Spine (Phila Pa 1976). 2006 Feb 15;31(4):377-81.
- Gerard Malanga. Corticosteroid in the Treatment of Acute Low Back Pain. www.spineuniverse.com.
- Korhonen T, Karppinen J, Malmivaara A, Autio R, Niinimäki J, Paimela L, Kyllönen E, Lindgren KA, Tervonen O, Seitsalo S, Hurri H. Efficacy of infliximab for disc herniation-induced sciatica: one-year follow-up. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2115-9.
- Korhonen T, Karppinen J, Paimela L, Malmivaara A, Lindgren KA, Bowman C, Hammond A, Kirkham B, Järvinen S, Niinimäki J, Veeger N, Haapea M, Torkki M, Tervonen O, Seitsalo S, Hurri H. The treatment of disc-herniation-induced sciatica with infliximab: one-year follow-up results of FIRST II, a randomized controlled trial. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2759-66.
- Patel N. Surgical disorders of the thoracic and lumbar spine: a guide for neurologists. J Neurol Neurosurg Psychiatry. 2002 Sep;73 Suppl 1:i42-8.
- HP-7-247S