Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of different treatments for pain caused by osteoarthritis at the base of the thumb. Specifically, it will compare two injections of Botox® (onabotulinumtoxinA) with one Botox® injection and one injection of a saltwater solution (normal saline), as well as two saline injections. The goal is to see which combination helps reduce pain the most after six months.

To participate in this study, you must be at least 18 years old and have significant pain in your thumb, with evidence of arthritis in that joint from an X-ray. There are some health conditions that would exclude you from participating, such as having had prior surgery on your thumb or certain neurological disorders. If you qualify and choose to take part, you will receive the designated injections and have the chance to help researchers understand better ways to treat thumb arthritis pain. Keep in mind that this trial is not yet recruiting participants, so you will need to wait for it to start if you're interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • 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 Criteria:
• • • 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