This study is a single-center, prospective, randomized controlled trial evaluating two types of pulsed radiofrequency (PRF) treatment for patients with pudendal neuralgia. Pudendal neuralgia is a chronic neuropathic pain affecting the perineum and pelvic area, often causing significant discomfort and reduced quality of life.
Patients will be randomly assigned to receive either conventional PRF or high-voltage long-duration PRF applied to the pudendal nerve. The study aims to compare the clinical effectiveness, pain relief, and safety of the two treatment approaches. Participants will be monitored for pain improvement, functional outcomes, and any treatment-related side effects.
The study follows standard clinical procedures and all treatments are performed under sterile conditions with proper monitoring to ensure patient safety.
Adults aged 18 years or older
Diagnosis of pudendal neuralgia according to the Nantes diagnostic criteria
Followed at the Algology (Pain Medicine) outpatient clinic
Chronic pudendal neuralgia refractory to conservative treatment or intolerance to conservative therapies
Presence of pelvic organic pathologies that may cause pudendal pain
Pain limited only to the coccygeal, gluteal, or lower abdominal regions
Patients with purely paroxysmal pain, isolated pruritus, or imaging findings that fully explain symptoms
History of malignancy or autoimmune disease
Parallel
Intervention Type * Select the type of intervention. Procedure / Surgery Intervention Name * Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available
Procedure/SurgeryConventional pulsed radiofrequency (PRF) is applied to the pudendal nerve at 42°C for 360 seconds, with a pulse frequency of 2 Hz and pulse width of 20 ms. The procedure is performed under sterile conditions in the operating room with patient monitoring (blood pressure, pulse, ECG, oxygen saturation). Patients are positioned prone, the target site is sterilized, and the PRF needle is placed under fluoroscopic guidance. Bilateral symptoms are treated sequentially if present.
High-Voltage Long-Duration Pulsed Radiofrequency
Procedure/SurgeryHigh-voltage long-duration pulsed radiofrequency (PRF) is applied to the pudendal nerve at 42°C for 900 seconds, with a pulse frequency of 2 Hz and pulse width of 20 ms. The voltage is titrated from 40V to a patient-tolerated maximum of 90V. The procedure is performed under sterile conditions in the operating room with patient monitoring (blood pressure, pulse, ECG, oxygen saturation). Patients are positioned prone, the target site is sterilized, and the PRF needle is placed under fluoroscopic guidance. Bilateral symptoms are treated sequentially if present.
Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the change in NRS score from baseline to 6 months after treatment. Higher scores indicate greater pain intensity. NRS scores will also be recorded at 1 and 3 months to allow longitudinal comparison.
Global Perceived Effect (GPE) Score
Patient-reported global improvement will be assessed using the Global Perceived Effect (GPE) scale, a Likert-type scale ranging from -5 to +5, where negative values indicate worsening, 0 indicates no change, and positive values indicate improvement. Higher scores indicate a better perceived outcome.
Patient Satisfaction Score
Patient satisfaction with treatment will be assessed using a 5-point satisfaction scale ranging from 0 (not satisfied at all) to 4 (very satisfied).
Quality of Life Assessed by Short Form-36 (SF-36)
Health-related quality of life will be evaluated using the Short Form-36 (SF-36) questionnaire.
Adverse Events and Complications
All procedure-related adverse events and complications will be recorded throughout the study period.
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