Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia

NCT07084285 | Not Yet Recruiting Phase 3

• 2 other identifiers: APHP2206712024-511790-30
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervicobrachial Neuralgia

Keywords

Neuralgia; cervicobrachialgia; cervicobrachial neuralgia; Foraminal conflict; Posterior intra-articular injection; Cervical spinal injection et corticosteroid

Outcome Measures

Primary Outcomes (1)

• Radicular pain (RP) assessed using a simple self-administered numeric rating scale

  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.

  Month1

Secondary Outcomes (7)

• Cervical pain (numeric rating scale, self-administered)

  Day 15, Month1, Month2, Month3

• Neck Disability Index (NDI) score

  Month1 and Month3

• Professional status

  Month1 and Month3

• Self-administered EQ5D quality of life scale

  Month1 and Month3

• Radicular pain (RP) assessed using a simple self-administered numeric rating scale

  Over the 48 hours preceding the Day 15, the 2-month and the 3-month visits assessment.

Study Arms (2)

Dexamethasone

EXPERIMENTAL

A single dexamethasone injection via the posterior intra-articular route

Drug: Dexamethasone

Isotonic saline solution

PLACEBO COMPARATOR

A single isotonic saline solution posterior intra-articular injection

Other: Isotonic saline solution

Interventions

Dexamethasone DRUG

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

Dexamethasone

Isotonic saline solution OTHER

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

Isotonic saline solution

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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, 75014, France

Location

MeSH Terms

Conditions

Brachial Plexus Neuritis; Neuralgia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Camille DASTE, MD,PhD

  AP-HP centre , Université Paris-cité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille DASTE, MD,PhD

CONTACT

01 58 41 51 38; camille.daste@aphp.fr

Laetitia PEAUDECERF, PhD

CONTACT

01 58 41 12 13; laetitia.peaudecerf@aphp.fr

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: July 16, 2025
• First Posted: July 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)