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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:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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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