Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia

Not Applicable

Recruiting

• Conditions: Pulsed Radiofrequency; Pudendal Neuralgia

• Registration Number: NCT06461312
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Patients with pudendal neuralgia suffer from long-term pain, which severely affects their quality of life. Due to unclear etiology, there is a lack of specific treatment methods. The aim of this study is to evaluate the efficacy of combined pulsed radiofrequency with ganglion impar block therapy helps evaluate the effectiveness of this treatment method for pudendal neuralgia, comparing it with traditional treatments or single interventions, and providing guidance for clinical practice.

Detailed Description

We plan to enroll patients with pudendal neuralgia .Pre-treatment, we collected data including pain assessment, anxiety, depression, catastrophizing, and pain sensitivity scales. Treatment involved ultrasound-guided pudendal nerve pulsed radiofrequency and X-ray-guided ganglion impar block. The Patient Global Impression of Change (PGIC) and Numeric Rating Scale (NRS) were used as the main observation indicators to evaluate the treatment effect at 1, 2, 3, and 6 months postoperatively, followed by correlation analysis with the scores of relevant scales.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Age between 18 and 80 years old;
2. Diagnosis of pudendal neuralgia meets the Nantes criteria. essential criteria include the following：1）Pain in the territory of the pudendal nerve；2） Pain is predominantly experienced while sitting；3) The pain does not wake the patient at night；4）Pain with no objective sensory impairment；5）Pain relieved by diagnostic pudendal nerve block；
3. Received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects.
4. Capable of signing informed consent form.

Exclusion Criteria

1. Pain caused by pelvic malignant diseases or autoimmune diseases;
2. Pain caused by pelvic surgery;
3. Taking anticoagulant drugs or having abnormal coagulation function;
4. Pregnancy;
5. Systemic infectious diseases;
6. Inability to complete scale assessments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	6months	0 -100%#0=no change,100%= complete relief of pain symptoms.

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale	6months	0-10#0 =no pain, 10 = the most severe pain.

Trial Locations

Locations (1)

People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China