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Efficacy of Soluble Dexamethasone in Refractory Sciatica

Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05000658
Acronym
Dexhia
Enrollment
109
Registered
2021-08-11
Start date
2021-12-16
Completion date
2023-03-15
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sciatica

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

DRUGDexamethasone phosphate

HSC injection of 4mL

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Effectiveness assessed by classical global algo-functional index: OSWESTRYWeek 3

Secondary

MeasureTime frame
Value of Eva scale for evaluated effectiveness on sciatic painWeek 1
Number of days off workMonth 6
Value of score to scale OswestryMonth 6
Value of score to SF36 self questionnairesMonth 6
Value of Eva scale for evaluated effectiveness on lower back painMonth 6
Number of patients undergoing secondary surgeryMonth 6
Result of Clinical parametersweek 3
Result of Imaging parametersweek 3
Number of secondary effectsMonth 6
Percentage of second injections requiredMonth 6

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026