About this trial
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 criteria
Qualifiers
• 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;
Disqualifiers
• 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;
Trial design
Treatments tested in this trial
- OnabotulinumtoxinA
- Normal saline (placebo)
Treatment groups
Locations
1Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator