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Starting soon Phase 3

Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia

NCT07084285 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-01
Last updated
2025-08-12

Condition(s) studied

Cervicobrachial Neuralgia

Investigational drug(s) / intervention(s)

Dexamethasone →Isotonic saline solution

Dexamethasone: A single 4mg (1mL) dexamethasone injection via the posterior intra-articular route, under CT guidance

Isotonic saline solution: 1 mL isotonic saline solution, injectable, for a single posterior intra-articular injection, under CT guidance.

Study summary

The main objective is to evaluate the efficacy of a single posterior intra-articular injection of dexamethasone on radicular pain (RP) at 1 month in the treatment of uncomplicated chronic cervicobrachial neuralgia (CBN) in adults, resistant to well-conducted first-line medical treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years, * Unilateral monoradicular cervicobrachial neuralgia (CBN), * Predominant radicular pain, with a Radicular Visual Analog Scale (VAS) score ≥ 40/100, * Imaging (CT or preferably MRI) performed within the last 6 months, * Foraminal conflict at one level on imaging (CT or preferably MRI) performed within the last 6 months, confirmed by a senior investigator trained in the study, * Failure of medical treatment that included at least one analgesic (level I to III) and one oral anti-inflammatory (NSAIDs and/or corticosteroids) for at least 7 consecutive days within the last 3 months, * Discontinuation of oral anti-inflammatory drugs (NSAIDs and/or corticosteroids) 24 hours prior to randomization, * Current episode duration ≥ 3 months, * Negative pregnancy test on the day of the procedure for premenopausal female patients, * Patients of childbearing age must have reliable contraception for the duration of the study, * Absence of biological inflammatory syndrome, thrombocytopenia, or coagulation disorders on the day of the procedure, * Patient capable of providing written informed consent prior to participating in the study. Exclusion Criteria: * Inability to speak, read, or write French fluently, * Patient under guardianship or custody, or deprived of liberty, * No affiliation with social security, * Neurological signs of severity (clinical motor deficit ≤ 3/5, pyramidal irritation signs, or cervical spinal cord edema on MRI), * Non-concordant imaging within the last 6 months (absence of conflict, contralateral conflict, or ipsilateral conflict not immediately adjacent), confirmed by a senior investigator trained in the study, * Recent cervical spine injection (\< 3 months), * Foraminal conflict at more than 2 levels, * History of cervical spine surgery within the last 12 months or scheduled surgery in this indication within 6 months, * Secondary CBN (traumatic, infectious, neoplastic, or inflammatory etiology), * Contraindication to fluoroscopy-guided injection (contrast agent allergy, allergy or contraindication to dexamethasone administration), * Pregnant women, * Ongoing participation in another therapeutic trial or interventional research study, * Patient suspected of non-compliance with the study protocol.

Primary outcome measure(s)

  • Radicular pain (RP) assessed using a simple self-administered numeric rating scale — Month1
    Simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the 1-month visit assessment.

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin Paris Île-de-France Region
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07084285 on ClinicalTrials.gov ↗ ← All trials in France