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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Conventional PRF | Experimental | Conventional Pulsed Radiofrequency Description: Conventional PRF applied to the pudendal nerve at 42°C for 360 seconds, 2 Hz, 20 ms pulse width. Standard clinical procedure under sterile conditions. |
|
| Arm 2 - High-Voltage Long-Duration PRF | Experimental | High-Voltage Long-Duration Pulsed Radiofrequency Description: High-voltage, long-duration PRF applied to the pudendal nerve at 42°C for 900 seconds, voltage titrated from 40V to patient-tolerated maximum of 90V. Procedure performed under sterile conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 3 months, and 6 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Şükriye Dadalı, MD | Contact | +905333316636 | sukriyedadali@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
Individual participant data are not shared due to institutional and legal restrictions on patient data protection.
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Participants will be randomly assigned to one of two parallel groups. One group will receive conventional pulsed radiofrequency (PRF) of the pudendal nerve, and the other group will receive high-voltage long-duration PRF. Each participant will receive only one type of intervention.
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| High-Voltage Long-Duration Pulsed Radiofrequency | Procedure | 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 guidance. Bilateral symptoms are treated sequentially if present. |
|
| 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). | Baseline, 1 month, 3 months, and 6 months |
| 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. | Baseline and 6 months |
| Adverse Events and Complications | All procedure-related adverse events and complications will be recorded throughout the study period. | From intervention to 6 months |
| ID | Term |
|---|---|
| D060545 | Pudendal Neuralgia |
| ID | Term |
|---|---|
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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