Statistical analysis
The primary outcome measure was pain intensity
(pain NRS 0–10). Sample size calculation was performed
a priori considering a 2.0 point difference for
the intensity outcome and an estimated SD of 2.5
points29; 80% statistical power, α=5% and a possible
sample loss of 15% were considered. Thus, 30
patients were needed per group (60 in total).
Using descriptive statistics, the data on variables