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Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

NCT ID: NCT00516009

Last Updated: 2007-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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RADICULAR PAIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 TREATMENT GROUP

20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS

Group Type EXPERIMENTAL

DEXAMETHASONE

Intervention Type DRUG

2

20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type OTHER

Interventions

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DEXAMETHASONE

Intervention Type DRUG

PLACEBO

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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RADI SHAHIEN, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center

Locations

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Neurology Unit - Ziv Mc

Safed, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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RADI SHAHIEN, MD

Role: CONTACT

[email protected]
972 4 6828928

Facility Contacts

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RADI SHAHIEN, MD

Role: primary

[email protected]
972 4 6828928

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12185261 (View on PubMed)

Gerard Malanga. Corticosteroid in the Treatment of Acute Low Back Pain. www.spineuniverse.com.

Reference Type BACKGROUND

Boqing C and Patrick M. Epidural Steroid Injections. August 11, 2005; www.emedicine.com.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16481946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15454701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17108825 (View on PubMed)

Other Identifiers

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HP-7-247S

Identifier Type: -

Identifier Source: org_study_id