Overview

Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis

Status:
Completed
Trial end date:
2021-04-23
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
URC CIC - Cochin
Treatments:
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