Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sciatica

Intervention / Treatment
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* Procedure: ultrasound-guided
* Procedure: interlaminar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound-guided<br>ultrasound-guided caudal epidural corticosteroid injection | Procedure: ultrasound-guided<br>* ultrasound-guided caudal epidural corticosteroid injection<br>|
| Active Comparator: interlaminar<br>interlaminar epidural corticosteroid injection | Procedure: interlaminar<br>* interlaminar epidural corticosteroid injection<br>|

What is the study measuring?
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Primary Outcome Measures

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