Efficacy of Soluble Dexamethasone in Refractory Sciatica

Phase 3

Completed

• Conditions: Sciatica
• Interventions: Drug: Dexamethasone phosphate

• Registration Number: NCT05000658
• Lead Sponsor: Nantes University Hospital

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

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-11
• Study Start: 2021-12-16
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Dexamethasone phosphate	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)
group B	Dexamethasone phosphate	HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)

Primary Outcome Measures

Name	Time	Method
Effectiveness assessed by classical global algo-functional index: OSWESTRY	Week 3

Secondary Outcome Measures

Name	Time	Method
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 days off work	Month 6
Result of Clinical parameters	week 3
Number of secondary effects	Month 6
Number of patients undergoing secondary surgery	Month 6

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France