MedDataX Logo

Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

NCT ID: NCT02833116

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

radiculalgia chronic pain quality of life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Betamethasone

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

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

Group Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Betamethasone

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Basque Health Service

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Enrique Manuel Barez Hernandez

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Enrique Barez

Role: PRINCIPAL_INVESTIGATOR

Basque Health Service: Araba University Hospital

Borja Mugabure

Role: STUDY_DIRECTOR

Basque Health Service: Donosti University Hospital

Fernando Torre

Role: PRINCIPAL_INVESTIGATOR

Basque Health Service: Galdakao University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Enrique Barez

Vitoria-Gasteiz, Álava, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Enrique Barez

Role: CONTACT

Phone: +34945007246

Email: [email protected]

Amanda Lopez

Role: CONTACT

Phone: +34945007413

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Enrique Barez

Role: primary

Amanda Lopez

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Beta-Dexa-Caudal

Identifier Type: -

Identifier Source: org_study_id