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

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Betamethasone
Dexamethasone
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring radiculalgia, chronic pain, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Enrique BarezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Betamethasone

Group Dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain.
Pain according to numerical visual pain scale.

Secondary Outcome Measures

Quality of life.
Quality of life according to SF-36.
Pain.
Pain according to numerical visual pain scale.
Adverse events.
Adverse events.

Full Information

First Posted
July 12, 2016
Last Updated
October 24, 2016
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT02833116
Brief Title
Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia
Acronym
BetaDexaCaudal
Official Title
Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
radiculalgia, chronic pain, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Betamethasone
Arm Type
Experimental
Arm Description
One ampule containing 12 mg of betamethasone in a syringe of 10 ml
Arm Title
Group Dexamethasone
Arm Type
Active Comparator
Arm Description
One ampule containing 4 mg of dexamethasone in a syringe os 10 ml
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Pain.
Description
Pain according to numerical visual pain scale.
Time Frame
3 months.
Secondary Outcome Measure Information:
Title
Quality of life.
Description
Quality of life according to SF-36.
Time Frame
7 days, 1, 3 and 6 months.
Title
Pain.
Description
Pain according to numerical visual pain scale.
Time Frame
7 days, 1, 3 and 6 months.
Title
Adverse events.
Description
Adverse events.
Time Frame
7 days, 1, 3 and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Barez
Phone
+34945007246
Email
ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Lopez
Phone
+34945007413
Email
AMANDA.LOPEZPICADO@osakidetza.eus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Barez
Organizational Affiliation
Basque Health Service: Araba University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Borja Mugabure
Organizational Affiliation
Basque Health Service: Donosti University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fernando Torre
Organizational Affiliation
Basque Health Service: Galdakao University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enrique Barez
City
Vitoria-Gasteiz
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Barez
Phone
+34945007275
Email
ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Amanda Lopez
Phone
+34945007413
Email
AMANDA.LOPEZPICADO@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Borja Mugabure
First Name & Middle Initial & Last Name & Degree
Fernando Torre

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

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