Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia (BetaDexaCaudal)

October 24, 2016 updated by: Enrique Manuel Barez Hernandez, Basque Health Service

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain.
Time Frame: 3 months.
Pain according to numerical visual pain scale.
3 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beta-Dexa-Caudal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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