Efficacy of Soluble Dexamethasone in Refractory Sciatica

• Status: Not yet recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Dexamethasone; Dexamethasone 21-phosphate

Criteria

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