Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

NCT02833116 | Unknown Phase 4

• 1 other identifier: Beta-Dexa-Caudal
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

radiculalgia; chronic pain; quality of life

Outcome Measures

Primary Outcomes (1)

• Pain.

  Pain according to numerical visual pain scale.

  3 months.

Secondary Outcomes (3)

• Quality of life.

  7 days, 1, 3 and 6 months.

• Pain.

  7 days, 1, 3 and 6 months.

• Adverse events.

  7 days, 1, 3 and 6 months.

Study Arms (2)

Group Betamethasone

EXPERIMENTAL

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

Drug: Betamethasone

Group Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Betamethasone DRUG

Group Betamethasone

Dexamethasone DRUG

Group Dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Enrique Barez

Vitoria-Gasteiz, Álava, 01009, Spain

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Betamethasone; Dexamethasone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Enrique Barez

  Basque Health Service: Araba University Hospital

  PRINCIPAL INVESTIGATOR

• Borja Mugabure

  Basque Health Service: Donosti University Hospital

  STUDY DIRECTOR

• Fernando Torre

  Basque Health Service: Galdakao University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Barez

CONTACT

+34945007246; ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus

Amanda Lopez

CONTACT

+34945007413; AMANDA.LOPEZPICADO@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2020
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)