Efficacy of Soluble Dexamethasone in Refractory Sciatica

NCT ID: NCT05000658

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2023-03-15

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

Conditions

Sciatica

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Dexamethasone phosphate

Intervention Type: DRUG

HSC injection of 4mL

group B

HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)

Group Type: PLACEBO_COMPARATOR

Dexamethasone phosphate

Intervention Type: DRUG

HSC injection of 4mL

Interventions

Dexamethasone phosphate

HSC injection of 4mL

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maugars

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC21_0148

Identifier Type: -

Identifier Source: org_study_id