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

January 30, 2020 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasound-guided
ultrasound-guided caudal epidural corticosteroid injection
Procedure: ultrasound-guided
ultrasound-guided caudal epidural corticosteroid injection
Active Comparator: interlaminar
interlaminar epidural corticosteroid injection
Procedure: interlaminar
interlaminar epidural corticosteroid injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry questionnaire
Time Frame: day 15 - month 1 - month 3 - month 6
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
Time Frame: day 15 - month 1 - month 3 - month 6
pain numerical scale lower or equal to 3/10
day 15 - month 1 - month 3 - month 6
neurological deficiency assessed by neurological examination
Time Frame: day 15 - month 1 - month 3 - month 6
motor weakness or sensitive deficiency in lower limbs
day 15 - month 1 - month 3 - month 6
drugs
Time Frame: day 15 - month 1 - month 3 - month 6
decrease in analgesic treatment
day 15 - month 1 - month 3 - month 6
medical outcome
Time Frame: day 15 - month 1 - month 3 - month 6
Medical Outcome study Short Form (SF-36)
day 15 - month 1 - month 3 - month 6
resumption of work
Time Frame: day 15 - month 1 - month 3 - month 6
deadline of resumption of work
day 15 - month 1 - month 3 - month 6
number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: day 15 - month 1 - month 3 - month 6
adverse events assessed by CTCAE v4.0
day 15 - month 1 - month 3 - month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01502-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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