Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

RADICULAR PAIN Clinical Trial

Official title:

Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00516009
• Other study ID #: HP-7-247S
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2007
• Last updated: August 13, 2007
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: August 2007
• Source: Ziv Hospital
• Contact: RADI SHAHIEN, MD
• Phone: 972 4 6828928
• Email: shahien.r[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• RADICULAR PAIN

Intervention

Drug:
• DEXAMETHASONE

Other:
• PLACEBO

Locations

Country	Name	City	State
Israel	Neurology Unit - Ziv Mc	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Malanga GA, Dennis RL. Use of medications in the treatment of acute low back pain. Clin Occup Environ Med. 2006;5(3):643-53, vii. Review. — View Citation

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. — View Citation