Interpreting non-inferiority in a prematurely terminated trial: concerns regarding cooled versus standard radiofrequency ablation for facetogenic low back pain

I read with interest the article by Provenzano et al1 reporting a prospective, multicenter, randomized trial comparing cooled radiofrequency ablation (CRFA) with standard radiofrequency ablation (SRFA) for chronic facetogenic lumbar back pain. The authors are to be commended for undertaking a head-to-head comparison of these two widely used techniques in a rigorous, prospective design with clinically meaningful endpoints. However, several methodological concerns warrant discussion, particularly as the findings may influence treatment selection and reimbursement decisions.