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Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Z

Ziv Hospital

Status

Unknown

Conditions

RADICULAR PAIN

Treatments

Drug: DEXAMETHASONE
Other: PLACEBO

Study type

Interventional

Funder types

Other

Identifiers

NCT00516009
HP-7-247S

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

1 TREATMENT GROUP
Experimental group
Description:
20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS
Treatment:
Drug: DEXAMETHASONE
2
Placebo Comparator group
Description:
20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS
Treatment:
Other: PLACEBO

Trial contacts and locations

1

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Central trial contact

RADI SHAHIEN, MD

Data sourced from clinicaltrials.gov

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