Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Peroneal Motor Nerve Conduction Velocity
研究概览
简要总结
Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN.
详细描述
A total of 118 patients with DPN will be recruited and randomly assigned in a 1:1 ratio to either the MA group or SA group. All patients will receive 24 sessions over 12 weeks. Participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline. Secondary outcomes include peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL) at week 12 and month 6 compared with baseline. Safety will be assessed during the whole trial. Masking effectiveness will be assessed by patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years (either sex)
- •Patients who meet diagnosis of DPN defined by ADA in 2005：a. DPN is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes, after the exclusion of other causes. b. NP is defined as altered sensitivity to pressure and (1) altered sensitivity to pain or (2) altered sensitivity to vibration or (3) achilles reflex.
- •Symmetric and predominantly sensory, starting from the lower limbs distally and gradually spreading proximally in a glove-and-stocking distribution.
- •Ability to understand study procedures and willingness to comply with them for the entire period of study.
- •Written informed consent
排除标准
- •PN caused by conditions other than diabetes (e.g.,alcohol abuse, chemotherapy, hereditary causes, chronic inflammatory, or idiopathic PN)
- •Psychiatric illnesses other than mild depression.
- •Severe or unstable cardiovascular, liver, kidney, respiratory, or hematological disorders.
- •Received acupuncture treatment in the last 3 months.
- •Pregnant or lactating women.
- •Research unit personnel directly related to the study and their immediate family members.
- •Incapable of giving informed consent or following the study instructions due to language disturbances, serious cognitive deficits, or lack of time.
- •Currently participating in other clinical trials.
结局指标
主要结局
Peroneal Motor Nerve Conduction Velocity
时间窗: 12 week
Measurement by electromyography
次要结局
- Michigan Neuropathy Screening Instrument (MNSI) score(12 week)
- Glycated hemoglobin (HbA1c)(12 week)
- Fasting plasma glucose (FPG)(12 week)
- 2-h postprandial blood glucose (2hPG)(12 week)
- Quality of life (QoL)(12 week)
- Sural Sensory Nerve Conduction Velocity(12 week)