Efficacy of Soluble Dexamethasone in Refractory Sciatica

Sciatica Clinical Trial

— Dexhia  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000658
• Other study ID #: RC21_0148
• Status: Completed
• Phase: Phase 3
• Start date: December 16, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• Dexamethasone phosphate
HSC injection of 4mL

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness assessed by classical global algo-functional index: OSWESTRY		Week 3
Secondary	Value of Eva scale for evaluated effectiveness on lower back pain		Month 6
Secondary	Value of Eva scale for evaluated effectiveness on lower back pain		Week 1
Secondary	Value of Eva scale for evaluated effectiveness on lower back pain		Week 3
Secondary	Value of Eva scale for evaluated effectiveness on lower back pain		Week 6
Secondary	Value of Eva scale for evaluated effectiveness on lower back pain		Month 3
Secondary	Value of Eva scale for evaluated effectiveness on sciatic pain		Week 1
Secondary	Value of Eva scale for evaluated effectiveness on sciatic pain		Week 3
Secondary	Value of Eva scale for evaluated effectiveness on sciatic pain		Week 6
Secondary	Value of Eva scale for evaluated effectiveness on sciatic pain		Month 6
Secondary	Number of days off work		Month 6
Secondary	Value of score to scale Oswestry		Month 6
Secondary	Value of score to scale Oswestry		Week 1
Secondary	Value of score to scale Oswestry		Week 6
Secondary	Value of score to scale Oswestry		Month 3
Secondary	Value of score to SF36 self questionnaires		Month 6
Secondary	Value of score to SF36 self questionnaires		Week 1
Secondary	Value of score to SF36 self questionnaires		Week 3
Secondary	Value of score to SF36 self questionnaires		Week 6
Secondary	Value of score to SF36 self questionnaires		Month 3
Secondary	Percentage of second injections required		Month 6
Secondary	Number of patients undergoing secondary surgery		Month 6
Secondary	Result of Clinical parameters		week 3
Secondary	Result of Imaging parameters		week 3
Secondary	Number of secondary effects		Month 6