Clinical trial NCT05000658: Efficacy of Soluble Dexamethasone in Refractory Sciatica
Official title: Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sciatica
Keywords: Reluctant Sciatica, Infiltrations, Soluble Dexamethasone
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Effectiveness assessed by classical global algo-functional index: OSWESTRY
timeFrame: Week 3
Secondary outcomes:
measure: Value of Eva scale for evaluated effectiveness on lower back pain
timeFrame: Month 6
measure: Value of Eva scale for evaluated effectiveness on lower back pain
timeFrame: Week 1
measure: Value of Eva scale for evaluated effectiveness on lower back pain
timeFrame: Week 3
measure: Value of Eva scale for evaluated effectiveness on lower back pain
timeFrame: Week 6
measure: Value of Eva scale for evaluated effectiveness on lower back pain
timeFrame: Month 3
measure: Value of Eva scale for evaluated effectiveness on sciatic pain
timeFrame: Week 1
measure: Value of Eva scale for evaluated effectiveness on sciatic pain
timeFrame: Week 3
measure: Value of Eva scale for evaluated effectiveness on sciatic pain
timeFrame: Week 6
measure: Value of Eva scale for evaluated effectiveness on sciatic pain
timeFrame: Month 6
measure: Number of days off work
timeFrame: Month 6
measure: Value of score to scale Oswestry
timeFrame: Month 6
measure: Value of score to scale Oswestry
timeFrame: Week 1
measure: Value of score to scale Oswestry
timeFrame: Week 6
measure: Value of score to scale Oswestry
timeFrame: Month 3
measure: Value of score to SF36 self questionnaires
timeFrame: Month 6
measure: Value of score to SF36 self questionnaires
timeFrame: Week 1
measure: Value of score to SF36 self questionnaires
timeFrame: Week 3
measure: Value of score to SF36 self questionnaires
timeFrame: Week 6
measure: Value of score to SF36 self questionnaires
timeFrame: Month 3
measure: Percentage of second injections required
timeFrame: Month 6
measure: Number of patients undergoing secondary surgery
timeFrame: Month 6
measure: Result of Clinical parameters
timeFrame: week 3
measure: Result of Imaging parameters
timeFrame: week 3
measure: Number of secondary effects
timeFrame: Month 6
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Maugars
role: PRINCIPAL_INVESTIGATOR
References: