Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve

Official title

Comparing Conventional and High-Voltage Long-Duration Pulsed Radiofrequency Applied to the Pudendal Nerve in the Treatment of Pudendal Neuralgia: A Randomized Controlled Trial

Overview

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.

Detailed description

This single-center, prospective, randomized controlled trial aims to compare the clinical effectiveness and safety of conventional pulsed radiofrequency (PRF) versus high-voltage long-duration PRF applied to the pudendal nerve in patients with pudendal neuralgia.

Eligible patients will be randomly assigned to one of the two intervention groups. Conventional PRF will be applied at 42°C for 360 seconds, while high-voltage long-duration PRF will be applied at 42°C for up to 900 seconds, with voltage titrated from 40V to a patient-tolerated maximum of 90V. All procedures are performed under sterile conditions in an operating room with patient monitoring (blood pressure, pulse, ECG, and oxygen saturation).

Patients will be assessed for pain intensity, functional improvement, and adverse effects at scheduled follow-up visits. Bilateral symptoms will be treated sequentially if present. The study adheres to standard clinical safety procedures and no additional risk beyond routine clinical care is anticipated.

Interventions

• Procedure 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
  Conventional 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.
• Procedure High-Voltage Long-Duration Pulsed Radiofrequency
  High-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 g

Primary outcome measures

• Change in Pain Intensity Assessed by Numeric Rating Scale (NRS) [Time frame: Baseline, 1 month, 3 months, and 6 months]

Secondary outcome measures (4)

• Global Perceived Effect (GPE) Score [Time frame: Baseline, 1 month, 3 months, and 6 months]
• Patient Satisfaction Score [Time frame: Baseline, 1 month, 3 months, and 6 months]
• Quality of Life Assessed by Short Form-36 (SF-36) [Time frame: Baseline and 6 months]
• Adverse Events and Complications [Time frame: From intervention to 6 months]

Eligibility criteria

Inclusion criteria

• 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
• Not using neuropathic pain medications, or on a stable dose for at least 3 months prior to enrollment
• Ability to comply with study procedures and follow-up visits
• Ability to understand the study information and provide written informed consent

Exclusion criteria

• 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
• Previous surgery that may have altered the anatomy of the pudendal nerve region
• Pregnancy or suspected pregnancy
• Presence of a cardiac pacemaker or implanted electrical device
• Use of anticoagulant therapy or presence of uncorrectable coagulation disorders
• Active systemic infection or infection at the injection site
• Known hypersensitivity to metals
• Inability or unwillingness to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT07356102 · E2-25-10056

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗