This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica
Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
HSC injection of 4mL
Nantes University Hospital
Nantes, France
Effectiveness assessed by classical global algo-functional index: OSWESTRY
Time frame: Week 3
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Month 6
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Week 1
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Week 3
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Week 6
Value of Eva scale for evaluated effectiveness on lower back pain
Time frame: Month 3
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Week 1
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Week 3
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Week 6
Value of Eva scale for evaluated effectiveness on sciatic pain
Time frame: Month 6
Number of days off work
Time frame: Month 6
Value of score to scale Oswestry
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Time frame: Month 6
Value of score to scale Oswestry
Time frame: Week 1
Value of score to scale Oswestry
Time frame: Week 6
Value of score to scale Oswestry
Time frame: Month 3
Value of score to SF36 self questionnaires
Time frame: Month 6
Value of score to SF36 self questionnaires
Time frame: Week 1
Value of score to SF36 self questionnaires
Time frame: Week 3
Value of score to SF36 self questionnaires
Time frame: Week 6
Value of score to SF36 self questionnaires
Time frame: Month 3
Percentage of second injections required
Time frame: Month 6
Number of patients undergoing secondary surgery
Time frame: Month 6
Result of Clinical parameters
Time frame: week 3
Result of Imaging parameters
Time frame: week 3
Number of secondary effects
Time frame: Month 6