Efficacy of Soluble Dexamethasone in Refractory Sciatica

NCT05000658 | Completed Phase 3 DMC

• 1 other identifier: RC21_0148
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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

Conditions

Sciatica

Keywords

Reluctant Sciatica, Infiltrations, Soluble Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Effectiveness assessed by classical global algo-functional index: OSWESTRY

  Week 3

Secondary Outcomes (24)

• 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

Study Arms (2)

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

Dexamethasone phosphate DRUG

HSC injection of 4mL

group A; group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Sciatica

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maugars

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 11, 2021
• Study Start: December 16, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)