DEXAMETHASONE for Cervicobrachial neuralgia

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years,"}
• {"criterion_text":"- Patients of childbearing age must have reliable contraception for the duration of the study;"}
• {"criterion_text":"- Absence of biological inflammatory syndrome, thrombocytopenia, or coagulation disorders on the day of the procedure,"}
• {"criterion_text":"- Patient capable of providing written informed consent prior to participating in the study."}
• {"criterion_text":"- Unilateral monoradicular cervicobrachial neuralgia (CBN),due to uncarthrosis;,"}
• {"criterion_text":"- Predominant radicular pain, with a Radicular Visual Analog Scale (VAS) score ≥ 40/100,"}
• {"criterion_text":"- Imaging (CT or preferably MRI) performed within the last 6 months,"}
• {"criterion_text":"- 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,"}
• {"criterion_text":"- 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,"}
• {"criterion_text":"- Discontinuation of oral anti-inflammatory drugs (NSAIDs and/or corticosteroids) 24 hours prior to randomization,"}
• {"criterion_text":"- Current episode duration ≥ 3 months,"}
• {"criterion_text":"- Negative pregnancy test on the day of the procedure for premenopausal female patients,"}

Exclusion criteria

• {"criterion_text":"- Inability to speak, read, or write French fluently,"}
• {"criterion_text":"- Contraindication to fluoroscopy-guided injection (allergy or contraindication to the administration of contrast agent, allergy or contraindication to the administration of dexamethasone (local or general infection, or suspected infection, severe coagulation disorders) or hypersensitivity to any of the excipients contained in the drug)"}
• {"criterion_text":"- Pregnant women,"}
• {"criterion_text":"- Ongoing participation in another therapeutic trial or interventional research study,"}
• {"criterion_text":"- Patient suspected of non-compliance with the study protocol"}
• {"criterion_text":"- Patient under guardianship or custody, or deprived of liberty,"}
• {"criterion_text":"- No affiliation with social security,"}
• {"criterion_text":"- Neurological signs of severity (clinical motor deficit ≤ 3/5, pyramidal irritation signs, or cervical spinal cord edema on MRI),"}
• {"criterion_text":"- Non-concordant imaging within the last 6 months (absence of conflict, contralateral conflict, or ipsilateral conflict not immediately adjacent), or showing incompatible anatomy, confirmed by a senior investigator trained in the study,"}
• {"criterion_text":"- Recent cervical spine injection (< 3 months),"}
• {"criterion_text":"- Foraminal conflict at more than 2 levels,"}
• {"criterion_text":"- History of cervical spine surgery within the last 12 months or scheduled surgery in this indication within 6 months, In cases of previous cervical laminectomy, surgery within 2 levels of the infiltrated segment and/or the presence of a foraminotomy associated with the segment will be an absolute contraindication to infiltration,"}
• {"criterion_text":"- Secondary CBN (traumatic, infectious, neoplastic, or inflammatory etiology),"}

Primary endpoints

• {"endpoint_text":"- Radicular pain (RP) assessed using a 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 compared to the baseline.","definition_or_measurement_approach":"Radicular pain measured by a self-administered numeric rating scale 0-100 over the 48 hours preceding the Month 1 visit; comparison to baseline."}

Secondary endpoints

• {"endpoint_text":"- Cervical pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, 1 month, 2 month and 3 month,","definition_or_measurement_approach":"Cervical pain measured by self-administered numeric rating scale 0-100 over the 48 hours preceding specified visits (Day 15, Month 1, Month 2, Month 3)."}
• {"endpoint_text":"- The Neck Disability Index (NDI) score (self-administered functional scale, ranging from 0 to 50) at Month 1 and Month 3, and professional status (self-reported: employed, on sick leave, disabled, unemployed, inactive, retired) at Month 1 and Month 3,","definition_or_measurement_approach":"NDI self-administered score (0-50) at Month 1 and Month 3; self-reported professional status at Month 1 and Month 3."}
• {"endpoint_text":"- The self-administered EQ-5D-5L quality of life scale at Month 1 and Month 3,","definition_or_measurement_approach":"EQ-5D-5L self-administered quality of life questionnaire at Month 1 and Month 3."}
• {"endpoint_text":"- Radicular pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, month 2, and month 3,","definition_or_measurement_approach":"Radicular pain measured by self-administered numeric rating scale 0-100 over the 48 hours preceding Day 15, Month 2, and Month 3."}
• {"endpoint_text":"- The occurrence of adverse events (AEs) and serious adverse events (SAEs) at each visit. Surgical intervention will be considered as a SAE","definition_or_measurement_approach":"Recording of AEs and SAEs at each visit; surgical intervention classified as SAE."}
• {"endpoint_text":"- The use of analgesics (levels 1, 2, or 3) since the last visit, using a self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, 1, 2 and 3 months post-injection.","definition_or_measurement_approach":"Self-administered 4-level scale for analgesic consumption (never, several times a month, several times a week, daily) at Day 15, Month 1, Month 2, and Month 3."}

France

Earliest CTIS Part Ii Submission Date

19-02-2026

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

15

Number Of Sites

4

Number Of Participants

70

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France