Status:
NOT_YET_RECRUITING
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Base-of-thumb Osteoarthritis
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 sa...
Detailed Description
The base of the thumb is a frequent location of osteoarthritis. Base-of-thumb osteoarthritis affects middle-aged and older individuals and results in base-of-thumb pain and limitations in hand-specifi...
Eligibility Criteria
Inclusion
- • 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
Exclusion
- • 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06902805
Start Date
May 1 2025
End Date
May 1 2028
Last Update
April 18 2025
Active Locations (1)
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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