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 range18 Years
SexALL
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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;
* …
What they're measuring
1
Base-of-thumb pain on a self-administered 11-point numeric rating scale