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Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Primary Purpose

RADICULAR PAIN

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
DEXAMETHASONE
PLACEBO
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RADICULAR PAIN focused on measuring RADICULAR PAIN, DISC HERNIATION, DEXAMETHASONE, VAS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurology Unit - Ziv McRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 TREATMENT GROUP

2

Arm Description

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

20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 13, 2007
Last Updated
August 13, 2007
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00516009
Brief Title
Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
Official Title
Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ziv Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RADICULAR PAIN
Keywords
RADICULAR PAIN, DISC HERNIATION, DEXAMETHASONE, VAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 TREATMENT GROUP
Arm Type
Experimental
Arm Description
20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS
Intervention Type
Drug
Intervention Name(s)
DEXAMETHASONE
Intervention Type
Other
Intervention Name(s)
PLACEBO

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RADI SHAHIEN, MD
Phone
972 4 6828928
Email
shahien.r@ziv.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RADI SHAHIEN, MD
Organizational Affiliation
Ziv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology Unit - Ziv Mc
City
Safed
ZIP/Postal Code
13100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RADI SHAHIEN, MD
Phone
972 4 6828928
Email
shahien.r@ziv.health.gov.il
First Name & Middle Initial & Last Name & Degree
RADI SHAHIEN, MD

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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PubMed Identifier
12185261
Citation
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.
Results Reference
background
Citation
Gerard Malanga. Corticosteroid in the Treatment of Acute Low Back Pain. www.spineuniverse.com.
Results Reference
background
Citation
Boqing C and Patrick M. Epidural Steroid Injections. August 11, 2005; www.emedicine.com.
Results Reference
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PubMed Identifier
16481946
Citation
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.
Results Reference
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PubMed Identifier
15454701
Citation
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.
Results Reference
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PubMed Identifier
17108825
Citation
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.
Results Reference
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Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

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