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Clinical Trials/EUCTR2016-000407-84-ES
EUCTR2016-000407-84-ESActive, not recruitingPhase 1

Efficacy and safety of epidural administration of betamethasone and dexamethasone by caudal route for the treatment of radicular pain: randomized clinical trial.

Enrique Bárez Hernandez0 sitesStarted: February 23, 2016Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • - Unilateral pain secondary to lateral stenosis, disc protrusion or herniation
  • - Age between 18 and 80 years
  • - Moderate-severe pain (?4 VAS)
  • - Proper written and oral language proficiency
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 300
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

  • - Patients with high intracranial pressure
  • - Multiple sclerosis
  • - Guillain-Barré Syndrome
  • - Radiculopathy of vascular origin
  • - Prior spinal surgery
  • - Pregnant or lactating women
  • - Allergy or intolerance to any of the drugs used in the study
  • - Severe cognitive impairment
  • - Radicular or intradural injection
  • - Poorly controlled major psychiatric pathology
  • - Type I diabetes
  • - Type II uncontrolled diabetes (Hb1Ac?8, 5)
  • - Glaucoma
  • - Caudal equine syndrome
  • - Previous treatment with steroids and/or anesthetic local infiltration
  • - Central canal stenosis
  • - Oral corticoid chronic treatment without fixed pattern

Investigators

Sponsor
Enrique Bárez Hernandez

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