2. Results
A total of 15 patients with a mean age of 26.5 ± 6.1 years old (range 18–39) were included in the study, resulting in 30 operated joints. All except one patient were females (93.3%) (The study was designed to have an endpoint at five weeks post-operation. However, an ethical committee preliminary analysis in the study’s middle phase (including 15 patients from the 30 initially planned) found no significant differences between the placebo and inco-BoNT/A groups. Therefore, the ethics committee suggested stopping the study due to an apparent lack of clinical benefit of the drug in the initially designed time frame [