Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02833116

Acronym

BetaDexaCaudal

Enrollment

320

Registered

2016-07-14

Start date

2016-06-30

Completion date

2020-06-30

Last updated

2016-10-25

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

Conditions

Chronic Pain

Keywords

radiculalgia, chronic pain, quality of life

Brief summary

This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.

Interventions

DRUGBetamethasone

DRUGDexamethasone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc. * Age between 18 and 80 years. * Moderate to severe pain (NVS\>4). * Right proficient oral and written language.

Exclusion criteria

* Patients with high intracranial pressure. * Patients with Multiple Sclerosis. * Patients with Guillain-Barré syndrome radiculopathy of vascular origin. * Patients with previous lumbar surgery. * Patients pregnant or lactating. * Patients with allergy or intolerance to any of the drugs used. * Patients with severe cognitive impairment. * Patients with intrathecal injectio radiculalgia. * Patients with poorly controlled major psychiatric pathology. * Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac\>8.5). * Patients with glaucoma. * Patients with caudal equine syndrome. * Patients with pre-treatment with steroid injections/or local anesthetics. * Patients with central canal stenosis. * patients with chronic treatment with oral corticosteroids without stabilized pattern.

Design outcomes

Primary

Measure	Time frame	Description
Pain.	3 months.	Pain according to numerical visual pain scale.

Secondary

Measure	Time frame	Description
Quality of life.	7 days, 1, 3 and 6 months.	Quality of life according to SF-36.
Pain.	7 days, 1, 3 and 6 months.	Pain according to numerical visual pain scale.
Adverse events.	7 days, 1, 3 and 6 months.	Adverse events.

Countries

Spain

Contacts

Primary ContactEnrique Barez

ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus+34945007246

Backup ContactAmanda Lopez

AMANDA.LOPEZPICADO@osakidetza.eus+34945007413

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026