Efficacy of radiofrequency ablation versus ethanol ablation for Morton's neuroma: a clinical trial using patient recorded outcome measures

Abstract

Background Morton’s neuroma is a common cause of forefoot pain and can be difficult to treat. Ethanol ablation (ETA) and Radiofrequency ablation (RFA) are increasingly used for treatment of chronic Morton's neuroma. However, there is limited evidence on the effectiveness of these guided ablation therapies in relation to broad-ranging patient recorded outcome measures (PROMs), and prospective studies directly comparing the two interventions are lacking. In this pragmatic clinical trial, we aimed to compare the efficacy of Ethanol ablation (ETA) and Radiofrequency ablation (RFA) on patient recorded outcome measures (PROMs) in pain, function, and ability in patients with Morton's neuroma. Methods Participants with chronic Morton's neuroma were randomly assigned to either ETA or RFA. Outcome measures were the Visual Analogue Scale (VAS), the eight-domain Foot Health Status Questionnaire (FHSQ) and the Foot and Ankle Ability Measure (FAAM). These were assessed at baseline, three, and six months after treatment. Results Sixty-three participants were allocated to either RFA (n=35) or ETA (n=28). A slight decrease in pain ascertained through VAS scores was observed in both intervention groups over six months relative to baseline. FAAM scores moderately improved in both groups over six months, with ETA showing a marginally greater mean change compared to RFA (3.8 points; p=0.004). FHSQ scores improved from baseline to six months in both groups, across all domains except vigour, which decreased in both interventions over three months and then stabilised in the ETA group at six months. Between-group differences of minor clinical importance favouring the ETA group were reported in improvement from baseline to six months of foot pain (3.7 points on 100 point scale; p<0.005), foot function (3.3 points; p=0.017), general health (2.5 points; p=0.013), and physical activity (11.0 points; p<0.001). Conclusion In the treatment of chronic Morton’s neuroma, ETA and RFA appear to confer comparable six-month improvements in pain, foot health, function, and ability. Multi-dimensional scales such as the FHSQ and the FAAM potentially elicit substantial treatment-related improvements that are not evident from VAS. Accordingly, incorporation of diverse PROMs into clinical assessments may enhance therapeutic decision-making and research in this context. Trial registration Australian New Zealand Trials Registry (ANZCTR) ACTRN12622000912785 (retrospectively registered on 27/06/2022