Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica
HiatUS
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 31, 2020
January 1, 2020
1.4 years
August 31, 2016
January 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
lower limbs pain
a 30% decrease in lower limbs pain using a visual analog scale
day 15
Secondary Outcomes (7)
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
day 15 - month 1 - month 3 - month 6
neurological deficiency assessed by neurological examination
day 15 - month 1 - month 3 - month 6
drugs
day 15 - month 1 - month 3 - month 6
medical outcome
day 15 - month 1 - month 3 - month 6
- +2 more secondary outcomes
Study Arms (2)
ultrasound-guided
EXPERIMENTALultrasound-guided caudal epidural corticosteroid injection
interlaminar
ACTIVE COMPARATORinterlaminar epidural corticosteroid injection
Interventions
ultrasound-guided caudal epidural corticosteroid injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Caen, 14000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 13, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 31, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share