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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University Hospital, Caen

Current Primary Outcome: lower limbs pain [ Time Frame: day 15 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Oswestry questionnaire [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    low back pain disability assessment using Oswestry questionnaire
  • A decrease of radicular pain with a pain numerical scale lower or equal to 3/10 [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    pain numerical scale lower or equal to 3/10
  • neurological deficiency assessed by neurological examination [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    motor weakness or sensitive deficiency in lower limbs
  • drugs [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    decrease in analgesic treatment
  • medical outcome [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    Medical Outcome study Short Form (SF-36)
  • resumption of work [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    deadline of resumption of work
  • number of patients with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: day 15 - month 1 - month 3 - month 6 ]
    adverse events assessed by CTCAE v4.0


Original Secondary Outcome: Same as current

Information By: University Hospital, Caen

Dates:
Date Received: August 31, 2016
Date Started: July 2016
Date Completion: June 2018
Last Updated: September 7, 2016
Last Verified: September 2016