BetaDexaCaudal: Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

Sponsor

Basque Health Service (Other)

Overall Status

Unknown status

CT.gov ID

NCT02833116

Collaborator

(none)

320

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: Betamethasone Drug: Dexamethasone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Betamethasone One ampule containing 12 mg of betamethasone in a syringe of 10 ml	Drug: Betamethasone
Active Comparator: Group Dexamethasone One ampule containing 4 mg of dexamethasone in a syringe os 10 ml	Drug: Dexamethasone

Arm

Intervention/Treatment

Experimental: Group Betamethasone

One ampule containing 12 mg of betamethasone in a syringe of 10 ml

Drug: Betamethasone

Active Comparator: Group Dexamethasone

One ampule containing 4 mg of dexamethasone in a syringe os 10 ml

Drug: Dexamethasone

Outcome Measures

Primary Outcome Measures

Pain. [3 months.]
Pain according to numerical visual pain scale.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Enrique Barez	Vitoria-Gasteiz	Álava	Spain	01009

Sponsors and Collaborators

Basque Health Service

Investigators

Principal Investigator: Enrique Barez, Basque Health Service: Araba University Hospital
Study Director: Borja Mugabure, Basque Health Service: Donosti University Hospital
Principal Investigator: Fernando Torre, Basque Health Service: Galdakao University Hospital