The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The change of VAS scores from baseline to the completion of treatment
研究概览
简要总结
The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial evaluating the efficacy and safety of a new intelligent electroacupuncture instrument in treating neck pain caused by cervical spondylosis.
详细描述
A total of 160 eligible patients will be included in this trial and randomly assigned to experimental group and control group in a 1:1 ratio. In experimental group, selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for control group, electroacupuncture treatment will be accomplished by a pre-existing electro-acupuncture instrument. The duration of treatment will be 2 weeks. The primary outcome is the change of visual analog scale score after one course of treatment. The secondary outcomes are visual analog scale score after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse events, defect rate of instrument, and excellent rate of instrument.
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
- None
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
- •Male or female between 18 and 75 years old.
- •Subject is diagnosed with CS of neck type or nerve-root type by clinical and medical imaging examination.
- •A history of recurrent episodes of neck pain (one or more neck pain per month lasting for more than 3 months).
- •Pain intensity is more than 3 points on a VAS upon recruitment.
- •Subject or his guardian comprehend the aims of this trial, promise not to accept other relative treatments during the trial, and sign the informed consent.
排除标准
- •Subject has acute neck trauma.
- •Previous medical history of neck trauma treated by surgery, or neurological deficit, or congenital and developmental spinal disorders, or systemic bone diseases, or systemic joint diseases (e.g. joint slippage).
- •Subject is diagnosed with carotid artery dissection.
- •Subject is unable to express clearly self-feelings (e.g. subject with severe cerebrovascular accident sequelae).
- •Subject has infection in acupuncture region.
- •A history of acupuncture treatment for neck pain in the previous 1 week.
- •Use of non-steroidal antipyretic analgesics in the previous 3 days.
- •Subject has to use central analgesics or narcotic analgesics (e.g. Tramadol, Morphine, Dolantin) during the period of clinic trial.
- •Use of various ointments or medicinal liquors with functions of promoting blood circulation and/or easing pain.
- •Use of oral and intravenous medicines with functions of opening blood vessels and providing nutrition to nerve.
- •Combinations of severe systematic diseases (e.g. a history of myocardial infarction, or severe hepatic and renal dysfunction, or acute infectious diseases, or malignant tumors, or severe mental disturbance diseases in previous 12 months).
- •Intolerance of acupuncture and electro-acupuncture.
- •Allergy to acupuncture.
- •Female in pregnancy or lactation.
- •Subject participate other clinic trials in previous 3 months.
- •Subject is considered to be unsuited to this trial by investigators.
研究组 & 干预措施
Experimental group
Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.
干预措施: intelligent electroacupuncture instrument (Device)
Control group
Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.
干预措施: Hwato electroacupuncture instrument (Device)
结局指标
主要结局
The change of VAS scores from baseline to the completion of treatment
时间窗: 0-2 weeks
次要结局
- VAS score after each treatment(0-2weeks)
- Responder rate(0-2weeks)
- Use of non-steroidal antipyretic analgesics(0-2weeks)
- Adverse events(0-2weeks)