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.
Cervicobrachial Neuralgia (CBN) is a common condition caused by the compression of a nerve root (C5, C6, C7, or C8) in the cervical spine. In 10% of cases, the duration of symptoms exceeds 3 months, at which point it is considered chronic. Two main etiologies are distinguished : * Soft disc herniation, * uncodiscarthrotic foraminal stenosis. The pathophysiology involves both mechanical compression and local inflammation. The initial management is typically medical, provided if there are no signs of severity. If medical treatment fails or if signs of severity are present, surgical intervention is required. The role of corticosteroid injections in the therapeutic strategy in France remains controversial. Literature on the efficacy of cervical spinal injections is heterogeneous and limited, the safety of such injections is debated, and product availability is restricted. We hypothesize that posterior intra-articular dexamethasone injection would be effective for radicular pain resistant to first-line medical treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
A single 4mg (1mL) dexamethasone injection via the posterior intra-articular route, under CT guidance
1 mL isotonic saline solution, injectable, for a single posterior intra-articular injection, under CT guidance.
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, France
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.
Time frame: Month1
Cervical pain (numeric rating scale, self-administered)
Numeric rating scale, self-administered, ranging from 0 to 100 over the 48 hours preceding Day 15, 1 month, 2 month and 3 month
Time frame: Day 15, Month1, Month2, Month3
Neck Disability Index (NDI) score
Self-administered functional scale, ranging from 0 to 50 at Month 1 and Month 3
Time frame: Month1 and Month3
Professional status
Self-reported : employed, on sick leave, disabled, unemployed, inactive, retired at Month 1 and Month 3
Time frame: Month1 and Month3
Self-administered EQ5D quality of life scale
Time frame: Month1 and Month3
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 visit assessment
Time frame: Over the 48 hours preceding the Day 15, the 2-month and the 3-month visits assessment.
The occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day15, Month1, Month2, Month3
The use of analgesics (levels 1, 2, or 3) since the last visit
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Self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, month1, month2 and 3 months post-injection.
Time frame: Day 15, Month1, Month2, Month3