A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in the study and sign the informed consent form;
- •The age is between 18 (inclusive) and 85 (inclusive), regardless of gender;
- •Body mass index (BMI) ≤ 45;
- •Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later;
- •Glycated hemoglobin<8%;
- •Not participating in the drug/medical device test within 3 months before the test;
排除标准
- •Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score
- •Ulcer is red and swollen, or active inflammatory infection;
- •The affected limb has lesions such as blackening and gangrene of the toe skin;
- •Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors;
- •Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects);
- •The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets);
- •People with allergic diseases and allergic constitution;
- •Have a history of drug abuse or drug addiction;
- •There are contraindications to pulsed radio frequency therapy;
结局指标
主要结局
Numeric Rating Scale
时间窗: up to 4 months
Numeric Rating Scale is the most widely used one-dimensional assessment scale，The higher the number, the more severe the pain
次要结局
未报告次要终点
研究者
Ke Ma
Principal Investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine