Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 106
- 试验地点
- 5
- 主要终点
- Responder rate
研究概览
简要总结
The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.
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
- Quadruple (Participant, Care Provider, 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
- •FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
- •Complete spontaneous bowel movements (CSBMs) per week < 3;
- •No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.
排除标准
- •Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
- •Have a cardiac pacemaker implantation or other electronically implanted devices;
- •Prior taVNS treatment;
- •History of colorectal surgery, except for simple appendectomy;
- •Severe cardiovascular, hepatic, or renal disease;
- •Known malignancy;
- •Secondary constipation caused by medications and other diseases;
- •Pregnant or lactating women;
- •Refusal to sign an informed consent.
研究组 & 干预措施
Treatment group
patients will receive taVNS at left tragus for four weeks.
干预措施: taVNS (Device)
Treatment group
patients will receive taVNS at left tragus for four weeks.
干预措施: Laxative Agent (Drug)
Sham-treatment group
patients will receive sham-taVNS at left earlobe for four weeks.
干预措施: taVNS (Device)
Sham-treatment group
patients will receive sham-taVNS at left earlobe for four weeks.
干预措施: Laxative Agent (Drug)
结局指标
主要结局
Responder rate
时间窗: 4 weeks
Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks
次要结局
- Adverse events(12 weeks)
- Responder rate at the time of the follow-up visit(8 weeks)
- Bristol stool form scale (BFSF)(12 weeks)
- Patient Assessment of Constipation symptom (PAC-SYM)(12 weeks)
- Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)(12 weeks)
- CSBMs(12 weeks)
- Self-Rating Depression Scale (SDS)(12 weeks)
- Self-Rating Anxiety Scale (SAS)(12 weeks)
- Spontaneous bowel movements (SBMs)(12 weeks)
- Abdominal symptoms(12 weeks)
- Laxative agents using(12 weeks)
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China