Cooled radiofrequency ablation for the treatment of refractory postamputation neuroma-associated pain: A prospective pilot study.

Abstract

Radiofrequency ablation (RFA) of neuromas has emerged as a potential treatment option for refractory neuroma-associated postamputation pain (PAP). To evaluate the feasibility of using internally cooled radiofrequency ablation (C-RFA) for treating neuroma-associated PAP. Prospective single-arm pilot study. Tertiary academic medical center. Eight participants with neuroma-associated PAP (mean age 56.5 [interquartile range, 50.5-68.5] years; mean body mass index 30.2 [interquartile range, 26.3-34.8] kg/m²). Participants were recruited and treated with C-RFA between 2019 and 2023. Pain and functional outcomes were assessed at 1, 3, 6, and 12 months after C-RFA using Numeric Rating Scale (NRS), Groningen Activity Restriction Scale (GARS), Patient Global Impression of Change (PGIC), and Medication Quantification Scale III (MQS-III). Responder definitions for each outcome measure were ≥50% NRS reduction, ≥30% GARS improvement, ≥6 on PGIC, and ≥6.8-point MQS-III reduction. NRS responder rates at 1, 3, 6, and 12 months were 25.0% (95% CI, 7.0%-59.1%), 50.0% (95% CI, 21.5%-78.5%), 37.5% (95% CI, 13.7%-69.4%), and 50.0% (95% CI, 21.5%-78.5%), respectively. Responder rates for GARS were 25.0% (95% CI, 7.1%-59.1%) at 1 month and 12.5% (95% CI, 2.2%-47.1%) at 3, 6, and 12 months. The proportion of PGIC responders was 37.5% (95% CI, 13.7%-69.4%) at 1 and 3 months and 12.5% (95% CI, 2.2%-47.1%) at 6 and 12 months. MQS-III responder rates were 25.0% (95% CI, 7.1%-59.1%) at 1 month, 12.5% (95% CI, 2.2%-47.1%) at 3 months, and 37.5% (95% CI, 13.7%-69.4%) at 6 and 12 months. There were no complications associated with the C-RFA procedure. These findings indicate the feasibility of neuroma C-RFA as a treatment for refractory neuroma-associated PAP but also suggest that further patient selection and C-RFA technique optimization are warranted before investigating this treatment paradigm in a larger prospective study.