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

NCT ID: NCT06461312

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-31

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.

Conditions

Pudendal Neuralgia; Pulsed Radiofrequency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

enrolled patients

Enrolled patients underwent pulsed radiofrequency of the pudendal nerve combined with ganglion impar block after pudendal nerve diagnostic block

Group Type: EXPERIMENTAL

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Intervention Type: PROCEDURE

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Interventions

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Feng, MD

director of department of Anesthesiology and Pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yiming Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

People's Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yifan Yang, MD

Role: CONTACT

enayanyan0227@126.com

18701545165

Facility Contacts

Yiming Liu, MD

Role: primary

enayanyan0227@126.com

88325206

Other Identifiers

2024PHB200-001

Identifier Type: -

Identifier Source: org_study_id