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
NCT Number: NCT07084285
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Paris, Île-de-France Region, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Day 15, Month1, Month2, Month3
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: Month1 and Month3
Self-administered functional scale, ranging from 0 to 50 at Month 1 and Month 3
Time frame: Month1 and Month3
Self-reported : employed, on sick leave, disabled, unemployed, inactive, retired at Month 1 and Month 3
Time frame: Month1 and Month3
Time frame: Over the 48 hours preceding the Day 15, the 2-month and the 3-month visits assessment.
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: Day15, Month1, Month2, Month3
Time frame: Day 15, Month1, Month2, Month3
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.
Contact information is provided by the study sponsor or research team.
Camille DASTE, MD,PhD
CONTACT
01 58 41 51 38 ext. +33
Laetitia PEAUDECERF, PhD
CONTACT
01 58 41 12 13 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Cervical Facet Injection of Corticosteroids for the Management of Cervicobrachialgia : Protocol for a Randomized Pilot Study
Acronym: APICALE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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