Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy: a MulticentreRandomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Sensory conduction velocity of superficial peroneal nerve
研究概览
简要总结
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus, which mainly manifests symmetric pain, numbness, ankylosis, or with abdominal distension, abnormal sweating, and accompanied by glove-sock-like hyperalgesia or loss of sensation as the main symptom, which seriously affects the quality of life of patients. Although drug treatment has some effect, from the overall long-term perspective, long-term medication is easy to produce drug dependence, and often easy to cause ataxia, blurred vision, constipation, diplopia, nausea and other adverse drug reactions. Electroacupuncture treatment for DPN has certain advantages, with clear efficacy and no toxic side effects, and is being increasingly recognised by the public and professionals. The study is designed to observe the therapeutic effect and safety of electroacupuncture (EA) in the treatment of DPN.
详细描述
A total of 104 subjects with DPN who meet the inclusion criteria will be included in the study. Subjects will be classified as mild, moderate and severe in terms of severity by using the toronto clinical scoring system（TCSS）, and subsequently randomised into the EA group and the waiting list group by using a central randomisation system. The indexes of main outcome evaluation are: sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (MNCV) of the tibial and peroneal nerves of the lower extremities. The indexes of secondary outcome evaluation are: 1) Overall clinical effectiveness rate; 2) TCSS score; 3) Chinese medicine symptom score; 4) patient's global impression of change (PGIC); 5) regional temperature test; and 6) laboratory tests (glycosylated haemoglobin, fasting blood glucose, and postprandial 2h blood glucose). This study will evaluate the effectiveness of EA in treating DPN and assess the difference in the efficacy of EA in treating patients with DPN of different severity, as well as explore the feasibility of regional temperature as an indicator for assessing the efficacy of DPN. And based on the results, a standardised, effective and convenient EA treatment protocol will be established for promotion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •18 years ≤ age ≤ 85 years, disease duration is not limited, gender is not limited;
- •Lower limb neuromuscular electromyography showing reduced conduction velocity, and/or persistent pain and/or sensory abnormalities in the extremities (at least in both lower limbs), bilateral or unilateral weakened ankle reflexes, reduced vibration sensation, and a TCSS score ≥ 6;
- •Have normal communication skills;
- •No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;
- •those who voluntarily obeyed the study protocol and signed the informed consent form.
排除标准
- •Persons with peripheral neuropathy, ulcers and gangrene of the limbs caused by a variety of other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or persons with a history of skin ulcers or lesions that do not heal easily;
- •Presence of serious diseases, including renal disease, cardiovascular disease, pulmonary disease, liver disease or infectious disease, or malignant tumour and serious mental illness, etc;
- •Prior history of knee/hip replacement surgery or lower limb fracture within the past 3 months, and other conditions that may affect the assessment of neuropathy
- •Patients who have received acupuncture or moxibustion treatment for DPN within the past 3 months;
- •Volunteers who are participating in other interventional clinical trials;
- •Women who are preparing for pregnancy, pregnant or breastfeeding;
- •Those who have scars or hyperpigmentation of the skin at the testing site, which affects the accuracy of the test;
- •Unwilling to be randomly assigned to the waiting treatment group or electroacupuncture treatment group;
- •Chronic abuse of opioids, analgesics, illicit drugs or alcohol.
结局指标
主要结局
Sensory conduction velocity of superficial peroneal nerve
时间窗: Baseline, 6 weeks
Motor conduction velocity of tibial nerve
时间窗: Baseline, 6 weeks
Motor conduction velocity of Peroneal nerve
时间窗: Baseline, 6 weeks
Sensory conduction velocity of sural nerve
时间窗: Baseline, 6 weeks
次要结局
- Regional temperatures of instep(Baseline, 6 weeks)
- Patient Global Impression of Change(PGIC)(Baseline, 3 weeks, 6 weeks, 10 weeks)
- Toronto clinical scoring system（TCSS）(Baseline, 3 weeks, 6 weeks, 10 weeks)
- TCM syndromes efficacy score scale(Baseline, 3 weeks, 6 weeks, 10 weeks)
- Regional temperatures of palm(Baseline, 6 weeks)
- Glycated haemoglobin (HbA1c）(Baseline, 6 weeks)
- Fasting blood glucose (FPG)(Baseline, 3 weeks, 6 weeks, 10 weeks)
- 2-hour postprandial blood glucose (2hPG)(Baseline, 3 weeks, 6 weeks, 10 weeks)
- Overall clinical effectiveness rate(3 weeks, 6 weeks, 10 weeks)
- Regional temperatures of sole of the foot(Baseline, 6 weeks)
- Regional temperatures of back of the hand(Baseline, 6 weeks)
研究者
Jianqiao Fang
professor
Zhejiang Chinese Medical University