Percutaneous Radiofrequency Ablation for Trigeminal Neuralgia Management: A Randomized, Double-Blinded, Sham-Controlled Clinical Trial

Abstract

Abstract Trigeminal neuralgia, considered by many the worst pain that humankind can experience, has been called “the suicide disease.” Neuroablative procedures are good options when conservative treatment fails to promote pain relief or in those whose side effects are unbearable. The objective was to compare the effectiveness and safety of trigeminal percutaneous radiofrequency ablation in classical refractory trigeminal neuralgia in a prospective, randomized, double-blind, sham-controlled clinical trial. We included 30 consecutive patients with classical trigeminal neuralgia who had failed to respond to drug treatment. The patients were randomly assigned into two groups: a thermal radiofrequency and a sham group. The thermal radiofrequency group were submitted to a 75°C lesion for 60 seconds after proper sensory and motor stimulation. All steps were carried out in the sham group except the thermal lesion. Patients were evaluated using the Numerical Rating Scale (NRS), the 36-Item Short-Form Health Survey questionnaire, and anticonvulsant dose. After 1 month, the mean NRS score decreased from 9.2 to 0.7 in the radiofrequency group and from 8.9 to 5.8 in the sham group. This significant reduction was measurable starting at day one after the procedure and remained significant throughout the first month. Changing groups was allowed after one month, after which the pain reduction was similar between the two groups. Percutaneous trigeminal radiofrequency ablation results in statistically and clinically significant greater pain relief than the sham procedure after 1 month of follow-up. These results support using radiofrequency nerve ablation as a treatment for refractory trigeminal neuralgia.