Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica - Full Text View

Sponsor:	Ziv Hospital
Information provided by:	Ziv Hospital
ClinicalTrials.gov Identifier:	NCT00516009

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Hernia Sciatica

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Estimated Enrollment:	40
Study Start Date:	August 2007
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
1 TREATMENT GROUP: Experimental 20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS	Drug: DEXAMETHASONE
2: Placebo Comparator 20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS	Other: PLACEBO

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516009

Contacts

Contact: RADI SHAHIEN, MD

972 4 6828928

shahien.r@ziv.health.gov.il

Locations

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

Sponsors and Collaborators

Ziv Hospital

Investigators

Principal Investigator:

RADI SHAHIEN, MD

ZIV MEDICAL CENTER

More Information

Publications:

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.

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. No abstract available.

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. 2006 Feb 15;31(4):377-81.

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. 2004 Oct 1;29(19):2115-9.

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. 2006 Nov 15;31(24):2759-66.

Study ID Numbers:	HP-7-247S
Study First Received:	August 13, 2007
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00516009 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Ziv Hospital:

RADICULAR PAIN
DISC HERNIATION
DEXAMETHASONE
VAS

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Dexamethasone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics

Hormones
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Hernia
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Dexamethasone acetate

ClinicalTrials.gov processed this record on November 25, 2009