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

Pudendal Neuralgia Clinical Trial

— PRF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461312
• Other study ID #: 2024PHB200-001
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Peking University People's Hospital
• Contact: Yifan Yang, MD
• Phone: 18701545165
• Email: enayanyan0227[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pudendal Neuralgia
• Pulsed Radiofrequency

Intervention

Procedure:
• Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block
Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Locations

Country	Name	City	State
China	People's Hospital of Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	1month
Primary	Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	2months
Primary	Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	3months
Primary	Patient Global Impression of Change	0 -100%#0=no change,100%= complete relief of pain symptoms.	6months
Secondary	Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	1month
Secondary	Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	2months
Secondary	Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	3months
Secondary	Numeric Rating Scale	0-10#0 =no pain, 10 = the most severe pain.	6months