Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Caen (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02897336
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultrasound-guided
  • Procedure: interlaminar
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. lower limbs pain [day 15]

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

Secondary Outcome Measures

  1. Oswestry questionnaire [day 15 - month 1 - month 3 - month 6]

    low back pain disability assessment using Oswestry questionnaire

  2. A decrease of radicular pain with a pain numerical scale lower or equal to 3/10 [day 15 - month 1 - month 3 - month 6]

    pain numerical scale lower or equal to 3/10

  3. neurological deficiency assessed by neurological examination [day 15 - month 1 - month 3 - month 6]

    motor weakness or sensitive deficiency in lower limbs

  4. drugs [day 15 - month 1 - month 3 - month 6]

    decrease in analgesic treatment

  5. medical outcome [day 15 - month 1 - month 3 - month 6]

    Medical Outcome study Short Form (SF-36)

  6. resumption of work [day 15 - month 1 - month 3 - month 6]

    deadline of resumption of work

  7. number of patients with treatment-related adverse events as assessed by CTCAE v4.0 [day 15 - month 1 - month 3 - month 6]

    adverse events assessed by CTCAE v4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Caen France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT02897336
Other Study ID Numbers:
  • 2015-A01502-47
First Posted:
Sep 13, 2016
Last Update Posted:
Jan 31, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Sciatica

Study Results

No Results Posted as of Jan 31, 2020