Sciatica
Conditions
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 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.
Interventions
PROCEDUREultrasound-guided
ultrasound-guided caudal epidural corticosteroid injection
PROCEDUREinterlaminar
interlaminar epidural corticosteroid injection
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lower limbs pain | day 15 | a 30% decrease in lower limbs pain using a visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A decrease of radicular pain with a pain numerical scale lower or equal to 3/10 | day 15 - month 1 - month 3 - month 6 | pain numerical scale lower or equal to 3/10 |
| neurological deficiency assessed by neurological examination | day 15 - month 1 - month 3 - month 6 | motor weakness or sensitive deficiency in lower limbs |
| drugs | day 15 - month 1 - month 3 - month 6 | decrease in analgesic treatment |
| Oswestry questionnaire | day 15 - month 1 - month 3 - month 6 | low back pain disability assessment using Oswestry questionnaire |
| resumption of work | 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 | day 15 - month 1 - month 3 - month 6 | adverse events assessed by CTCAE v4.0 |
| medical outcome | day 15 - month 1 - month 3 - month 6 | Medical Outcome study Short Form (SF-36) |
Countries
France
Outcome results
None listed