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
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 38
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Şükriye Dadalı
Principal Investigator, Department of Pain Medicine
Ankara City Hospital Bilkent