Efficacy of Soluble Dexamethasone in Refractory Sciatica (NCT05000658) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Soluble Dexamethasone in Refractory Sciatica
France109 participantsStarted 2021-12-16
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Effectiveness assessed by classical global algo-functional index: OSWESTRY