Sciatica
Conditions
Keywords
Reluctant Sciatica, Infiltrations, Soluble Dexamethasone
Brief summary
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
Detailed description
Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm
Interventions
HSC injection of 4mL
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral * Duration of evolution greater than 3 weeks despite analgesic / AINS treatment, and less than 3 months * EVA sciatica pain \> 4/10 * Oswestry 30 at inclusion * Patient aged 18 years and older * Patient affiliated to a social security scheme * Patient able to understand the protocol and having signed an informed consent * Patient with an indication for corticosteroid infiltration in the context of their pathology Criteria for non-inclusion * Signs or risks of infection, in particular signs of virosis * Poor local skin condition * Anticoagulation with VKA or anti-Xa, or haemorrhagic disease * Neurological deficit \< 3/5 or signs of cauda equina irritation * Tarlov's cyst or low dural sac below week 4 * Hypersensitivity to Lidocaine, Dexamethasone, or any of its excipients * Infiltration of the spine within the previous 3 months * Patient with bilateral sciatica * Patient with sciatica of osteoarthritic origin * Patients with chronic respiratory insufficiency * Pregnant or breastfeeding women or women refusing effective contraception until M3 * Patient deprived of liberty or under legal protection (guardianship or curatorship) * Patient under court protection * Patients participating in another clinical research protocol involving a drug or medical device * Patients unable to follow the protocol, as judged by the investigator * Patient refusing to participate in the study * Patient with clinically narrowed lumbar canal * Patient with polyneuropathy or myelopathy * Patient with sequelae of neuropathic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness assessed by classical global algo-functional index: OSWESTRY | Week 3 |
Secondary
| Measure | Time frame |
|---|---|
| Value of Eva scale for evaluated effectiveness on sciatic pain | Week 1 |
| Number of days off work | Month 6 |
| Value of score to scale Oswestry | Month 6 |
| Value of score to SF36 self questionnaires | Month 6 |
| Value of Eva scale for evaluated effectiveness on lower back pain | Month 6 |
| Number of patients undergoing secondary surgery | Month 6 |
| Result of Clinical parameters | week 3 |
| Result of Imaging parameters | week 3 |
| Number of secondary effects | Month 6 |
| Percentage of second injections required | Month 6 |
Countries
France