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

P

Peking University

Status

Enrolling

Conditions

Pulsed Radiofrequency
Pudendal Neuralgia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06461312
2024PHB200-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

enrolled patients
Experimental group
Description:
Enrolled patients underwent pulsed radiofrequency of the pudendal nerve combined with ganglion impar block after pudendal nerve diagnostic block
Treatment:
Procedure: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Trial contacts and locations

1

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Central trial contact

Yifan Yang, MD

Data sourced from clinicaltrials.gov

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