Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2007 by Ziv Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Ziv Hospital

ClinicalTrials.gov Identifier:

NCT00516009

First received: August 13, 2007

Last updated: NA

Last verified: August 2007

History: No changes posted

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

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.

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

Keywords provided by Ziv Hospital:

RADICULAR PAIN
DISC HERNIATION
DEXAMETHASONE
VAS

Additional relevant MeSH terms:

Hernia
Sciatica
Pathological Conditions, Anatomical
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate

BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013

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