Clinical trial NCT00516009: Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
Official title: Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: RADICULAR PAIN
Keywords: RADICULAR PAIN
DISC HERNIATION
DEXAMETHASONE
VAS
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2007-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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,
* Severe congestive heart failure,
* Cauda equina syndrome,
* Moderate or severe motor deficit,
* Primary spinal stenosis,
* Pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Neurology Unit - Ziv Mc
Study officials:
affiliation: Ziv Medical Center
name: RADI SHAHIEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Patel N. Surgical disorders of the thoracic and lumbar spine: a guide for neurologists. J Neurol Neurosurg Psychiatry. 2002 Sep;73 Suppl 1(Suppl 1):i42-8. doi: 10.1136/jnnp.73.suppl_1.i42. No abstract available.
citation: Gerard Malanga. Corticosteroid in the Treatment of Acute Low Back Pain. www.spineuniverse.com.
citation: Boqing C and Patrick M. Epidural Steroid Injections. August 11, 2005; www.emedicine.com.
citation: Finckh A, Zufferey P, Schurch MA, Balague 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. doi: 10.1097/01.brs.0000199917.04145.80.
citation: Korhonen T, Karppinen J, Malmivaara A, Autio R, Niinimaki J, Paimela L, Kyllonen 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. doi: 10.1097/01.brs.0000141179.58778.6c.
citation: Korhonen T, Karppinen J, Paimela L, Malmivaara A, Lindgren KA, Bowman C, Hammond A, Kirkham B, Jarvinen S, Niinimaki 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. doi: 10.1097/01.brs.0000245873.23876.1e.