Ultrasound-guided Caudal or Interlaminar Corticosteroid Epidural Injection for Sciatica

Sciatica Clinical Trial

— HiatUS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02897336
• Other study ID #: 2015-A01502-47
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sciatica

Intervention

Procedure:
• ultrasound-guided
ultrasound-guided caudal epidural corticosteroid injection
• interlaminar
interlaminar epidural corticosteroid injection

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower limbs pain	a 30% decrease in lower limbs pain using a visual analog scale	day 15
Secondary	Oswestry questionnaire	low back pain disability assessment using Oswestry questionnaire	day 15 - month 1 - month 3 - month 6
Secondary	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
Secondary	neurological deficiency assessed by neurological examination	motor weakness or sensitive deficiency in lower limbs	day 15 - month 1 - month 3 - month 6
Secondary	drugs	decrease in analgesic treatment	day 15 - month 1 - month 3 - month 6
Secondary	medical outcome	Medical Outcome study Short Form (SF-36)	day 15 - month 1 - month 3 - month 6
Secondary	resumption of work	deadline of resumption of work	day 15 - month 1 - month 3 - month 6
Secondary	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