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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pudendal Neuralgia; Pulsed Radiofrequency
• Intervention / Treatment: Procedure: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifan Yang, MD; Phone Number: 18701545165; Email: enayanyan0227@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • People's Hospital of Peking University
      • Contact: Yiming Liu, MD; Phone Number: 88325206; Email: enayanyan0227@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enrolled patients; Enrolled patients underwent pulsed radiofrequency of the pudendal nerve combined with ganglion impar block after pudendal nerve diagnostic block	Procedure: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block; Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	1month
Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	2months
Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	3months
Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	1month
Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	2months
Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	3months
Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	6months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Yiming Liu, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pudendal Neuralgia
• Other Study ID Numbers: 2024PHB200-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No