Taking people in FrancePhase 2/3
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 120 people, planned
- Started
- 3 Dec 2025
- Expected to end
- Nov 2028
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- OnabotulinumtoxinA
- Normal saline (placebo)
- Record updated
- 3 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- • Individuals aged at least 18 years; Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain); Pain involving the base of the thumb; X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts; 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis; Patient able to give written informed consent prior to participation in the study; Affiliation with a mode of social security (profit or being entitled); Negative pregnancy test in women of childbearing potential
Who cannot take part
- • Secondary osteoarthritis; History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy; Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders; Contra-indication to onabotulinumtoxinA; Neurological disorders involving the hands other than carpal tunnel syndrome; Collagen disorders involving the hands; Osteoarthritis predominating at the scaphotrapezial joint on x-ray; Bilateral trapezometacarpial osteoarthritis without a predominant painful side; Hand or wrist trauma for up to 2 months; Intra-articular treatments for up to 2 months; Use of IM, IV or oral corticosteroids for up to 2 months; Protected adults (including individual under guardianship by court order); Pregnant women and lactation; lack of contraception for women of childbearing potential; Patient participating in another investigational therapeutic study; Patient unable to speak and read french
Where in France
- 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 CochinParis, FranceContact: Christelle Nguyen, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- 2 intra-articular injections of onabotulinumtoxinATreatment being tested
Treatment: OnabotulinumtoxinA
- 1 intra-articular injection of onabotulinumtoxinA and 1 of normal salineTreatment being tested
Treatment: OnabotulinumtoxinA and Normal saline (placebo)
- 2 intra-articular injections of normal salinePlacebo, for comparison
Treatment: Normal saline (placebo)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms
- Record updated
- 3 April 2026