Actively Recruiting
Comparing Conventional and High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve in Pudendal Neuralgia Treatment: A Randomized Controlled Trial
Led by Ankara City Hospital Bilkent · Updated on 2026-01-22
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of pulsed radiofrequency (PRF) treatments for people with pudendal neuralgia, a chronic nerve pain affecting the pelvic area and perineum. This randomized controlled trial compares conventional PRF with high-voltage long-duration PRF to assess their effects on pain relief, function, and safety. The trial is conducted at a single center and follows standard clinical safety procedures to protect participants. Participants are randomly assigned to receive either conventional PRF applied at 42°C for 360 seconds or high-voltage long-duration PRF applied at 42°C for up to 900 seconds, with voltage adjusted from 40V to a patient-tolerated maximum of 90V. Both procedures are performed under sterile conditions with patients positioned prone, using fluoroscopic guidance and monitoring of vital signs. If symptoms affect both sides, treatments are done sequentially. During the study, participants will be assessed at baseline and at 1, 3, and 6 months for pain intensity using the Numeric Rating Scale, functional improvement, patient satisfaction, and quality of life through the Short Form-36 questionnaire. Researchers will also monitor adverse events throughout the study period. Treatments and follow-up visits involve standard clinical procedures to ensure patient safety and accurate data collection.
CONDITIONS
Brief Title
Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of pudendal neuralgia according to the Nantes diagnostic criteria
- Followed at the Algology outpatient clinic
- Chronic pudendal neuralgia not improved by conservative treatment or intolerance to such therapies
- Not using neuropathic pain medications or on a stable dose for at least 3 months prior
- Ability to comply with study procedures and follow-up visits
- Ability to understand study information and provide written informed consent
You will not qualify if you...
- Presence of pelvic organic pathologies causing pudendal pain
- Pain limited only to coccygeal, gluteal, or lower abdominal regions
- Purely paroxysmal pain, isolated itching, or imaging findings fully explaining symptoms
- History of malignancy or autoimmune disease
- Previous surgery altering pudendal nerve anatomy
- Pregnancy or suspected pregnancy
- Presence of cardiac pacemaker or implanted electrical device
- Use of anticoagulant therapy or uncorrectable coagulation disorders
- Active systemic infection or injection site infection
- Known hypersensitivity to metals
- Inability or unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure visit
Participants receive either conventional or high-voltage long-duration pulsed radiofrequency applied to the pudendal nerve under sterile conditions in an operating room. Bilateral symptoms are treated sequentially if present.
1 procedure visit (in-person)
Duration - 6 months
Participants are assessed for pain intensity, functional improvement, quality of life, and adverse effects at scheduled visits after the procedure.
Follow-up visits at 1 month, 3 months, and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
Research Team
Ş
Şükriye Dadalı, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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