Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica

Not Applicable

Withdrawn

• Conditions: Sciatica
• Interventions: Procedure: interlaminar; Procedure: ultrasound-guided

• Registration Number: NCT02897336
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interlaminar	interlaminar	interlaminar epidural corticosteroid injection
ultrasound-guided	ultrasound-guided	ultrasound-guided caudal epidural corticosteroid injection

Primary Outcome Measures

Name	Time	Method
lower limbs pain	day 15	a 30% decrease in lower limbs pain using a visual analog scale

Secondary Outcome Measures

Name	Time	Method
Oswestry questionnaire	day 15 - month 1 - month 3 - month 6	low back pain disability assessment using Oswestry questionnaire
neurological deficiency assessed by neurological examination	day 15 - month 1 - month 3 - month 6	motor weakness or sensitive deficiency in lower limbs
medical outcome	day 15 - month 1 - month 3 - month 6	Medical Outcome study Short Form (SF-36)
resumption of work	day 15 - month 1 - month 3 - month 6	deadline of resumption of work
drugs	day 15 - month 1 - month 3 - month 6	decrease in analgesic treatment
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
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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Caen, France