Efficacy of Soluble Dexamethasone in Refractory Sciatica | NCT05000658

Studies
Efficacy of Soluble Dexamethasone in Refractory Sciatica

NCT05000658

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Feb 1, 2024Actual

Enrollment

109Actual

Phase

Phase 3

Conditions

Sciatica

Interventions

Dexamethasone phosphate

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2021Actual

Primary Completion Date

Mar 15, 2023Actual

Completion Date

Mar 15, 2023Actual

First Submitted Date

Aug 4, 2021

First Submission Date that Met QC Criteria

Aug 4, 2021

First Posted Date

Aug 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2024

Last Update Posted Date

Feb 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Experimental	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
group B	Placebo Comparator	HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)	Drug: Dexamethasone phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone phosphate	Drug	HSC injection of 4mL	group A group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020426	Sciatic Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases