Lumbar epidural steroids.

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000407-84-ES

Enrollment

Unknown

Registered

2016-02-23

Start date

2016-04-20

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radiculalgia

Interventions

Trade Name: Celestone Cronodose Pharmaceutical Form: Suspension for injection Trade Name: Fortecortin Product Name: Fortecortin Product Code: 36225 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare, 3 months after the last infiltration, the number of patients in each group who achieve a pain reduction of 50% or more according to the numerical rating scale.;Secondary Objective: - Compare the number of patients in each group who achieve a pain reduction of 50% or more according to the numerical rating scale per week, per month and 6 months after the last infiltration. - Compare the pain reduction according to numerical rating scale among patients in each group one week, one month and 6 months after the last infiltration. - Compare the degree of disability based on the Oswestry scale a week, a month, at 3 and at 6 months after the last infiltration. - Compare the consumption of opioid and non-opioid analgesics between both groups a week, a month, at 3 and at 6 months after last infiltration. - Compare, 6 months after the last infiltration, patients? satisfaction with the treatment. - Compare the quality of life according, to the quality of life SF-36 questionnaire a week, a month, at 3 and at 6 months after the last infiltration. - Compare the number of adverse events in each group.;Primary end point(s): Pain: Numerical rating scale;Timepoint(s) of evaluation of this end point: 1 week from last infiltration 1, 3 y 6 months from last infiltration	—

Measure

Time frame

Main Objective: Compare, 3 months after the last infiltration, the number of patients in each group who achieve a pain reduction of 50% or more according to the numerical rating scale.;Secondary Objective: - Compare the number of patients in each group who achieve a pain reduction of 50% or more according to the numerical rating scale per week, per month and 6 months after the last infiltration. - Compare the pain reduction according to numerical rating scale among patients in each group one week, one month and 6 months after the last infiltration. - Compare the degree of disability based on the Oswestry scale a week, a month, at 3 and at 6 months after the last infiltration. - Compare the consumption of opioid and non-opioid analgesics between both groups a week, a month, at 3 and at 6 months after last infiltration. - Compare, 6 months after the last infiltration, patients? satisfaction with the treatment. - Compare the quality of life according, to the quality of life SF-36 questionnaire a week, a month, at 3 and at 6 months after the last infiltration. - Compare the number of adverse events in each group.;Primary end point(s): Pain: Numerical rating scale;Timepoint(s) of evaluation of this end point: 1 week from last infiltration 1, 3 y 6 months from last infiltration

—

Secondary

Measure	Time frame
Secondary end point(s): Oswestry Analgesic consumption Quality of life(SF-36) Satisfaction with the treatment Adverse events;Timepoint(s) of evaluation of this end point: 1 week from last infiltration 1, 3 y 6 months from last infiltration	—

Countries

Spain

Contacts

Public ContactEnrique Barez

Basque Health System

ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus945007276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026