Efficacy of Soluble Dexamethasone in Refractory Sciatica (Dexhia)

Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo

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

Study Overview

• Status: Completed
• Conditions: Sciatica
• Intervention / Treatment: Drug: Dexamethasone phosphate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Maugars; Phone Number: 0240084820; Email: yves.maugars@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Maugars, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Reluctant Sciatica, Infiltrations, Soluble Dexamethasone
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dexamethasone 21-phosphate
• Other Study ID Numbers: RC21_0148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No