Safety and efficacy of pulsed radiofrequency versus pulse dose mode radiofrequency targeting the pudendal nerve in patients with pudendal neuralgia: a prospective randomized controlled clinical trial.

Abstract

Background: Pudendal neuralgia is a painful, neuropathic condition involving the pudendal nerve dermatome. It is a difficult-to-treat chronic pain disorder that affects both men and women equally. The aim of this study was to detect the efficacy and safety of two distinctive therapeutic types of radiofrequency: pulsed radiofrequency and pulse dose radiofrequency, as treatment modalities for cases of pudendal neuralgia, assessed by changes in the Visual Analogue Scale between the two groups.

Methods: Of the one hundred patients enrolled for this study, 80 cases with pudendal neuralgia fulfilled the inclusion/exclusion criteria. They were randomly assigned into two groups: PRF Group, including 38 patients who underwent Pulsed radiofrequency, and PDRF Group, including 39 patients who underwent Pulse dose radiofrequency. The primary outcome was pain assessment using the visual analogue score, while the secondary outcome included the patient health questionnaire-9, the amount of postintervention drug utilization, and treatment adverse events.

Results: The two studied groups were matched for the basic demographic data. However, the difference in the mean VAS score was present over time within each group (P<0.05) but it was insignificant between the two groups at one hour, 48 hours, two weeks, one, three, and six months (P>0.05), PDRF Group showed a non-significant reduction in visual analogue score, compared to PRF Group. Additionally, there was a statistically significant reduction in patient health questionnaire-9 within each group over time, P<0.05. while between both groups at one, three, and six months, there was insignificant reduction among both groups (P>0.05) and more reduction in the PDRF group.

Conclusions: Both pulsed radiofrequency and pulse dose radiofrequency were equally effective and safe as a treatment method for managing pudendal neuralgia cases. Considering both modalities in cases with proven pudendal neuralgia is valuable.