Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made … (NCT06902805) | Clinical Trial Compass
RecruitingPhase 2/3
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
France120 participantsStarted 2025-12-03
Plain-language 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 saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Base-of-thumb pain on a self-administered 11-point numeric rating scale