Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
研究概览
简要总结
The objective of this trial is to compare the efficacy of electroacupuncture versus transcutaneous electric nerve stimulation for functional constipation
详细描述
Both electroacupuncture(EA) therapy and transcutaneous electric nerve stimulation(TENS) are safe and effective for functional constipation, but no head to head comparing trial was conducted.
Methods：102 participants with functional constipation will be recruited and randomly allocated into the EA group and the TENS group.Participants in both groups will receive EA or TENS treatment at Tianshu(ST 25), Fujie(SP 14) and Shangju xu(ST 37) 3 times a week for 8 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conforming to the criteria for the diagnosis of functional constipation in Rome III standard;
- •Aged of 18 to 75 years;
- •No medication for constipation has been used for at least 2 weeks before treatment. Except for emergency treatment, it has not received acupuncture treatment for constipation in the past 3 months, and has not participated in other ongoing clinical research.
排除标准
- •Constipation caused by irritable bowel syndrome and organically or medicated; secondary to endocrine, metabolic, neurogenic, or surgical constipation;
- •Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment.
- •Pregnant or lactation patients;
- •Subjects with abdominal aortic aneurysm, abnormal enlargement of liver and spleen and so on.
- •Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time.
- •Subjects installed with the cardiac pacemaker.
研究组 & 干预措施
Electroacupuncture
The treatment consists of 3 times a week for 8 weeks.Huatuo Brand needles (0.30×50mm or 0.30×70mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used for ST25, SP14 and ST37.After acupuncture，the needle handle will be connected with the electrode in the electroacupuncture instrument.
The parameters of the electric acupuncture apparatus：Dilatational wave，the frequency is 2/10Hz，the electric current intensity is 0.1mA-1.0mA.
干预措施: Electroacupuncture (Device)
TranscutaneousElectricNerveStimulation
The treatment consists of 3 times a week for 8 weeks.Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used for ST25, SP14 and ST37.
The parameters of the electric acupuncture apparatus：Dilatational wave，the frequency is 2/10Hz，the electric current intensity is 2mA-5mA.
干预措施: TranscutaneousElectricNerveStimulation (Device)
结局指标
主要结局
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
时间窗: Baseline，week 8
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
次要结局
- Change number of average score in defecation difficulty(Baseline，week 4，week 8, week 20 and week 32)
- The proportion and average amount of using cathartics(weeks -1 , 4 , 8 , 20 and 32.)
- The proportion of participants with an average increasing of one or more complete spontaneous bowel movements(Baseline，week 4，week 20 and week 32)
- Change number of PAC-QOL score(Baseline，week 8)
- Change number in CSBMS(Baseline，week 4，week 8, week 20 and week 32)
- Change number in SBMS(Baseline，week 4，week 8, week 20 and week 32)
- The proportion of participants with type3 or type 4 stool character(Baseline，week 4，week 8, week 20 and week 32)
研究者
Yuxiao Zeng
Postgraduate student of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences