Clinical trial NCT06461312: Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
Official title: Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pudendal Neuralgia
Pulsed Radiofrequency
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Global Impression of Change
timeFrame: 1month
measure: Patient Global Impression of Change
timeFrame: 2months
measure: Patient Global Impression of Change
timeFrame: 3months
measure: Patient Global Impression of Change
timeFrame: 6months
Secondary outcomes:
measure: Numeric Rating Scale
timeFrame: 1month
measure: Numeric Rating Scale
timeFrame: 2months
measure: Numeric Rating Scale
timeFrame: 3months
measure: Numeric Rating Scale
timeFrame: 6months
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yiming Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: