Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica

NCT ID: NCT02897336

Last Updated: 2020-01-31

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Sciatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasound-guided

ultrasound-guided caudal epidural corticosteroid injection

Group Type EXPERIMENTAL

ultrasound-guided

Intervention Type PROCEDURE

ultrasound-guided caudal epidural corticosteroid injection

interlaminar

interlaminar epidural corticosteroid injection

Group Type ACTIVE_COMPARATOR

interlaminar

Intervention Type PROCEDURE

interlaminar epidural corticosteroid injection

Interventions

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ultrasound-guided

ultrasound-guided caudal epidural corticosteroid injection

Intervention Type PROCEDURE

interlaminar

interlaminar epidural corticosteroid injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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2015-A01502-47

Identifier Type: -

Identifier Source: org_study_id

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