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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511790-30 | EudraCT Number |
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | A single dexamethasone injection via the posterior intra-articular route |
|
| Isotonic saline solution | Placebo Comparator | A single isotonic saline solution posterior intra-articular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | A single 4mg (1mL) dexamethasone injection via the posterior intra-articular route, under CT guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 15, Month1, Month2, Month3 |
| Neck Disability Index (NDI) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camille DASTE, MD,PhD | Contact | 01 58 41 51 38 | +33 | camille.daste@aphp.fr |
| Laetitia PEAUDECERF, PhD | Contact | 01 58 41 12 13 | +33 | laetitia.peaudecerf@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Camille DASTE, MD,PhD | AP-HP centre , Université Paris-cité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D020968 | Brachial Plexus Neuritis |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D020516 | Brachial Plexus Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Isotonic saline solution | Other | 1 mL isotonic saline solution, injectable, for a single posterior intra-articular injection, under CT guidance. |
|
Self-administered functional scale, ranging from 0 to 50 at Month 1 and Month 3 |
| Month1 and Month3 |
| Professional status | Self-reported : employed, on sick leave, disabled, unemployed, inactive, retired at Month 1 and Month 3 | 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 | Simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the visit assessment | 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) | Day15, Month1, Month2, Month3 |
| The use of analgesics (levels 1, 2, or 3) since the last visit | 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. | Day 15, Month1, Month2, Month3 |
|
| D009443 | Neuritis |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |