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

NCT06461312 | Recruiting

• 1 other identifier: 2024PHB200-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pudendal Neuralgia; Pulsed Radiofrequency

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Numeric Rating Scale

  1month

• Numeric Rating Scale

  2months

• Numeric Rating Scale

  3months

• Numeric Rating Scale

  6months

Study Arms (1)

enrolled patients

EXPERIMENTAL

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

Interventions

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block PROCEDURE

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years old;
• 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；
• Received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects.
• Capable of signing informed consent form.

You may not qualify if:

• Pain caused by pelvic malignant diseases or autoimmune diseases;
• Pain caused by pelvic surgery;
• Taking anticoagulant drugs or having abnormal coagulation function;
• Pregnancy;
• Systemic infectious diseases;
• Inability to complete scale assessments.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yiming Liu, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Yang, MD

CONTACT

18701545165; enayanyan0227@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of Anesthesiology and Pain medicine

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 17, 2024
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)