Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms
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.
• • 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