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