NCT05000658
Completed
Phase 3
Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo
Overview
- Phase
- Phase 3
- Intervention
- Dexamethasone phosphate
- Conditions
- Sciatica
- Sponsor
- Nantes University Hospital
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Effectiveness assessed by classical global algo-functional index: OSWESTRY
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
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
Exclusion Criteria
- Not provided
Arms & Interventions
group A
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)
Intervention: Dexamethasone phosphate
group B
HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)
Intervention: Dexamethasone phosphate
Outcomes
Primary Outcomes
Effectiveness assessed by classical global algo-functional index: OSWESTRY
Time Frame: Week 3
Secondary Outcomes
- Number of secondary effects(Month 6)
- Value of Eva scale for evaluated effectiveness on sciatic pain(Month 6)
- Percentage of second injections required(Month 6)
- Result of Imaging parameters(week 3)
- Value of Eva scale for evaluated effectiveness on lower back pain(Month 3)
- Value of score to scale Oswestry(Month 3)
- Value of score to SF36 self questionnaires(Month 3)
- Number of patients undergoing secondary surgery(Month 6)
- Number of days off work(Month 6)
- Result of Clinical parameters(week 3)
Study Sites (1)
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