umbar epidural steroids.

Phase 1

• Conditions: radiculalgia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000407-84-ES
• Lead Sponsor: Enrique Bárez Hernandez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-23
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified