Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient Global Impression of Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pain caused by pelvic malignant diseases or autoimmune diseases;
- •Pain caused by pelvic surgery;
- •Taking anticoagulant drugs or having abnormal coagulation function;
- •Systemic infectious diseases;
- •Inability to complete scale assessments.
结局指标
主要结局
Patient Global Impression of Change
时间窗: 6months
0 -100%#0=no change,100%= complete relief of pain symptoms.
次要结局
- Numeric Rating Scale(6months)
研究者
Yi Feng, MD
director of department of Anesthesiology and Pain medicine
Peking University People's Hospital