Miao Yu, Jia-Wang Li, Ruo-Wen Chen, Yong-Xiang Li, Ruo-Guo Wang, Qi-Wu Fang, John P Williams, Jian-Xiong An
High-voltage, long-duration pulsed radiofrequency combined with ozone therapy showed preliminary efficacy and an acceptable safety profile for patients with refractory pudendal neuralgia. These findings are hypothesis-generating; prospective controlled studies are warranted.
PURPOSE: To evaluate the feasibility, safety, and preliminary therapeutic efficacy of combining high-voltage long-duration pulsed radiofrequency with ozone therapy for patients with refractory Pudendal neuralgia (PN).
PATIENTS AND METHODS: Between January 2019 and December 2024, 18 patients diagnosed with PN based on clinical criteria and diagnostic nerve blocks were included after failing or declining conservative therapies. Following informed consent, all patients underwent a single session of high-voltage, long-duration pulsed radiofrequency treatment combined with ozone therapy, followed by supplementary ozone therapy during hospitalization. Outcomes were assessed using the Visual Analog Scale (VAS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), and SF-36 Health Survey at baseline, 1 week, 4 weeks, 12 weeks, and 24 weeks post-treatment by an independent assessor blinded to clinical details. The primary endpoint was the proportion of patients achieving ≥50% reduction in VAS pain score.
RESULTS: Fifteen patients completed follow-up (three lost to follow-up). At 12 weeks, 93.3% (14/15); achieved the primary endpoint, one patient had persistent pelvic pain but showed improvement in other outcome measures. At 24 weeks, 80.0% (12/15) maintained a favorable response; however, 3 patients experienced symptom recurrence around week 20 and requested retreatment. No serious adverse events were observed during treatment or follow-up periods.
CONCLUSION: High-voltage, long-duration pulsed radiofrequency combined with ozone therapy showed preliminary efficacy and an acceptable safety profile for patients with refractory pudendal neuralgia. These findings are hypothesis-generating; prospective controlled studies are warranted.