Efficacy of Soluble Dexamethasone in Refractory Sciatica (Dexhia)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3

Conditions: Sciatica

Treatments: Drug: Dexamethasone phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT05000658

RC21_0148

Details and patient eligibility

About

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

Full description

Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups, including a placebo group

group A

Experimental group

Description:

HSC one injection of 4 mL soluble Dexamethasone phosphate (16 mg) (equivalent to 100 mg Prednisone), followed by up to 16 mL saline (depending on tolerance)

Treatment:

Drug: Dexamethasone phosphate

group B

Placebo Comparator group

Description:

HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)

Treatment:

Drug: Dexamethasone phosphate