Overview
Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
Status:
Completed
Completed
Trial end date:
2021-04-23
2021-04-23
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Assistance Publique - Hôpitaux de ParisCollaborators:
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
URC CIC - CochinTreatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
Inclusion Criteria:- Age ≥ 18 years old
- Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
- Pain involving the base-of-thumb
- X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following
items involving the trapeziometacarpal joint : osteophytes, joint space narrowing,
subchondral bone sclerosis or subchondral cysts
- 1990 American College of Rheumatology classification criteria for hand osteoarthritis
adapted to base-of-thumb osteoarthritis
- Medical examination
- Written consent
- Health insurance
- For women of childbearing age, a negative urinary pregnancy test
Exclusion Criteria:
- History of thumb surgery
- History of inflammatory or crystal-associated rheumatic disease
- Neurological disorders involving the hands other than carpien canal syndrom
- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
- Hand or wrist trauma ≤ 2 months
- Hand or wrist intra-articular injections ≤ 2 months
- Contra-indication to botulinum toxin A injection or to splinting
- Cognitive or behavioral disorders making the assessment impossible
- Participant unable to speak, read and write french
- Bilateral BTOA without predominant symptomatic side
- Pregnancy and breast feeding
- Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected
minors or adults, guardianship or trusteeship, etc.)
- Patient with epilepsy