Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Normal saline (placebo): intra-articular injection
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Base-of-thumb pain on a self-administered 11-point numeric rating scale — 6 months French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)
Trial sites (1)
Facility
City
Region
Status
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
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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