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Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Ziv Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516009
First Posted: August 14, 2007
Last Update Posted: August 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ziv Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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.
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.
Boqing C and Patrick M. Epidural Steroid Injections. August 11, 2005; www.emedicine.com.

ClinicalTrials.gov Identifier: NCT00516009     History of Changes
Other Study ID Numbers: HP-7-247S
First Submitted: August 13, 2007
First Posted: August 14, 2007
Last Update Posted: August 14, 2007
Last Verified: August 2007

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
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action