Starting soon
Phase 3
Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia
Condition(s) studied
Cervicobrachial Neuralgia
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| 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 |
|
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