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Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica (HiatUS)

Primary Purpose

Sciatica

Status

Withdrawn

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ultrasound-guided

interlaminar

About this trial

This is an interventional treatment trial for Sciatica

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ultrasound-guided

interlaminar

Arm Description

ultrasound-guided caudal epidural corticosteroid injection

interlaminar epidural corticosteroid injection

Outcomes

Primary Outcome Measures

lower limbs pain

a 30% decrease in lower limbs pain using a visual analog scale

Secondary Outcome Measures

Oswestry questionnaire

low back pain disability assessment using Oswestry questionnaire

A decrease of radicular pain with a pain numerical scale lower or equal to 3/10

pain numerical scale lower or equal to 3/10

neurological deficiency assessed by neurological examination

motor weakness or sensitive deficiency in lower limbs

drugs

decrease in analgesic treatment

medical outcome

Medical Outcome study Short Form (SF-36)

resumption of work

deadline of resumption of work

number of patients with treatment-related adverse events as assessed by CTCAE v4.0

adverse events assessed by CTCAE v4.0

Full Information

NCT ID

NCT02897336

First Posted

August 31, 2016

Last Updated

January 30, 2020

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT02897336

Brief Title

Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica

Acronym

HiatUS

Official Title

Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Withdrawn

Study Start Date

July 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sciatica

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ultrasound-guided

Arm Type

Experimental

Arm Description

ultrasound-guided caudal epidural corticosteroid injection

Arm Title

interlaminar

Arm Type

Active Comparator

Arm Description

interlaminar epidural corticosteroid injection

Intervention Type

Procedure

Intervention Name(s)

ultrasound-guided

Intervention Description

ultrasound-guided caudal epidural corticosteroid injection

Intervention Type

Procedure

Intervention Name(s)

interlaminar

Intervention Description

interlaminar epidural corticosteroid injection

Primary Outcome Measure Information:

Title

lower limbs pain

Description

a 30% decrease in lower limbs pain using a visual analog scale

Time Frame

day 15

Secondary Outcome Measure Information:

Title

Oswestry questionnaire

Description

low back pain disability assessment using Oswestry questionnaire

Time Frame