Epidural Dexamethasone Versus Betamethasone for Treatment... | NCT02833116

Studies
Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

NCT02833116

Sponsor

Basque Health Service

Status

Unknown status

Last Update Posted

Oct 25, 2016Estimated

Enrollment

320Estimated

Phase

Phase 4

Conditions

Chronic Pain

Interventions

Betamethasone
Dexamethasone

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Jul 12, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Betamethasone	Drug		Group Betamethasone
Dexamethasone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Enrique Barez	Contact	+34945007246		ENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus
Amanda Lopez	Contact	+34945007413		AMANDA.LOPEZPICADO@osakidetza.eus

Overall Officials

Name	Affiliation	Role
Enrique Barez	Basque Health Service: Araba University Hospital	Principal Investigator
Borja Mugabure	Basque Health Service: Donosti University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Enrique Barez	Recruiting	Vitoria-Gasteiz	Álava	01009	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001623	Betamethasone
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided