NCT00516009

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 14, 2007

Status Verified

August 1, 2007

First QC Date

August 13, 2007

Last Update Submit

August 13, 2007

Conditions

RADICULAR PAIN

Keywords

RADICULAR PAINDISC HERNIATIONDEXAMETHASONEVAS

Study Arms (2)

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

Interventions

DEXAMETHASONEDRUG
1 TREATMENT GROUP
PLACEBOOTHER
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older presented with acute radicular pain for less than 6 weeks.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Unit - Ziv Mc

Safed, 13100, Israel

RECRUITING

Related Publications (8)

  • 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.

    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.

    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.

    PMID: 12185261BACKGROUND

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

    BACKGROUND

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

    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.

    PMID: 16481946BACKGROUND

  • 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.

    PMID: 15454701BACKGROUND

  • 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.

    PMID: 17108825BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • RADI SHAHIEN, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RADI SHAHIEN, MD

CONTACT

972 4 6828928shahien.r@ziv.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

August 1, 2007

Study Completion

July 1, 2008

Last Updated

August 14, 2007

Record last verified: 2007-08

Locations

IL(1)