Efficacy of Soluble Dexamethasone in Refractory Sciatica

Study 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

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

Conditions
-----------------
Sciatica

Intervention / Treatment
-----------------
* Drug: Dexamethasone phosphate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>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) | Drug: Dexamethasone phosphate<br>* HSC injection of 4mL<br>|
| Placebo Comparator: group B<br>HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance) | Drug: Dexamethasone phosphate<br>* HSC injection of 4mL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness assessed by classical global algo-functional index: OSWESTRY |  | Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of Eva scale for evaluated effectiveness on lower back pain |  | Month 6 | 
| Value of Eva scale for evaluated effectiveness on lower back pain |  | Week 1 | 
| Value of Eva scale for evaluated effectiveness on lower back pain |  | Week 3 | 
| Value of Eva scale for evaluated effectiveness on lower back pain |  | Week 6 | 
| Value of Eva scale for evaluated effectiveness on lower back pain |  | Month 3 | 
| Value of Eva scale for evaluated effectiveness on sciatic pain |  | Week 1 | 
| Value of Eva scale for evaluated effectiveness on sciatic pain |  | Week 3 | 
| Value of Eva scale for evaluated effectiveness on sciatic pain |  | Week 6 | 
| Value of Eva scale for evaluated effectiveness on sciatic pain |  | Month 6 | 
| Number of days off work |  | Month 6 | 
| Value of score to scale Oswestry |  | Month 6 | 
| Value of score to scale Oswestry |  | Week 1 | 
| Value of score to scale Oswestry |  | Week 6 | 
| Value of score to scale Oswestry |  | Month 3 | 
| Value of score to SF36 self questionnaires |  | Month 6 | 
| Value of score to SF36 self questionnaires |  | Week 1 | 
| Value of score to SF36 self questionnaires |  | Week 3 | 
| Value of score to SF36 self questionnaires |  | Week 6 | 
| Value of score to SF36 self questionnaires |  | Month 3 | 
| Percentage of second injections required |  | Month 6 | 
| Number of patients undergoing secondary surgery |  | Month 6 | 
| Result of Clinical parameters |  | week 3 | 
| Result of Imaging parameters |  | week 3 | 
| Number of secondary effects |  | Month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reluctant Sciatica, Infiltrations, Soluble Dexamethasone