Ultrasound-guided Caudal or Interlaminar Corticosteroid E... | NCT02897336

Studies
Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica

NCT02897336

Sponsor

University Hospital, Caen

Status

Withdrawn

Last Update Posted

Jan 31, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Sciatica

Interventions

ultrasound-guided
interlaminar

Countries

France

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 31, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 13, 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

Jan 30, 2020

Last Update Posted Date

Jan 31, 2020Actual

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

An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica.

Detailed Description

An open-label randomized trial conducted in one centre to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica. 30 male and female patients will be included in each group. The primary outcome measure will be a 30% decrease in lower limbs pain as assessed by a visual analog scale.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ultrasound-guided	Experimental	ultrasound-guided caudal epidural corticosteroid injection	Procedure: ultrasound-guided
interlaminar	Active Comparator	interlaminar epidural corticosteroid injection	Procedure: interlaminar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound-guided	Procedure	ultrasound-guided caudal epidural corticosteroid injection	ultrasound-guided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lower limbs pain	a 30% decrease in lower limbs pain using a visual analog scale	day 15

Secondary Outcomes

Measure	Description	Time Frame
Oswestry questionnaire	low back pain disability assessment using Oswestry questionnaire	day 15 - month 1 - month 3 - month 6
A decrease of radicular pain with a pain numerical scale lower or equal to 3/10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

radicular pain (sciatica or cruralgia) for more than 2 weeks
failure of analgesics and NSAIDs
without neurological deficiency (motor weakness lower or equal to 3/5)
a lumbar disk herniation on MRI or CT dating less than 3 months

Exclusion Criteria:

history of lumbar surgery
history of epidural injection during the last 3 months
radicular pain not due to disk herniation
a contraindication to epidural injection (infection, diabetes)
history of allergic reaction to corticosteroid
patient under legal guardianship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Caen		14000	France

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
D012585	Sciatica

Ancestor Terms

ID	Term
D020426	Sciatic Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided