Actively Recruiting
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-03
120
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.
CONDITIONS
Official Title
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged at least 18 years
- Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale
- Pain involving the base of the thumb
- X-ray evidence of trapezometacarpal osteoarthritis with at least two of the following: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts
- Meeting 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpal osteoarthritis
- Ability to give written informed consent before participation
- Affiliation with a mode of social security (profit or being entitled)
- Negative pregnancy test in women of childbearing potential
You will not qualify if you...
- Secondary osteoarthritis
- History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy
- Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or signs of neuromuscular transmission disorders
- Contraindication to onabotulinumtoxinA
- Neurological disorders involving the hands other than carpal tunnel syndrome
- Collagen disorders involving the hands
- Osteoarthritis mainly at the scaphotrapezial joint on x-ray
- Bilateral trapezometacarpal osteoarthritis without a dominant painful side
- Hand or wrist trauma within the last 2 months
- Intra-articular treatments within the last 2 months
- Use of intramuscular, intravenous, or oral corticosteroids within the last 2 months
- Protected adults including those under court guardianship
- Pregnant or breastfeeding women; lack of contraception in women of childbearing potential
- Participation in another investigational therapeutic study
- Inability to speak or read French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
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, 75014
Actively Recruiting
Research Team
C
Christelle NGUYEN, MD, PhD
CONTACT
L
Laetitia PEAUDECERF, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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