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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
ultrasound-guided caudal epidural corticosteroid injection
interlaminar epidural corticosteroid injection
University Hospital
Caen, France
lower limbs pain
a 30% decrease in lower limbs pain using a visual analog scale
Time frame: day 15
Oswestry questionnaire
low back pain disability assessment using Oswestry questionnaire
Time frame: 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
Time frame: day 15 - month 1 - month 3 - month 6
neurological deficiency assessed by neurological examination
motor weakness or sensitive deficiency in lower limbs
Time frame: day 15 - month 1 - month 3 - month 6
drugs
decrease in analgesic treatment
Time frame: day 15 - month 1 - month 3 - month 6
medical outcome
Medical Outcome study Short Form (SF-36)
Time frame: day 15 - month 1 - month 3 - month 6
resumption of work
deadline of resumption of work
Time frame: 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
Time frame: day 15 - month 1 - month 3 - month 6
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