EUCTR2016-000407-84-ES
Active, not recruiting
Phase 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 sitesFebruary 23, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- radiculalgia
- Sponsor
- Enrique Bárez Hernandez
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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