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 ]
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