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临床试验/NCT04349891
NCT04349891终止不适用

Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
2
主要终点
Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score

研究概览

简要总结

Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human.

Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients.

The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score

时间窗: Up to 10 weeks

The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe). GCSI total score can range from 0 to 5, with higher scores reflecting greater symptom severity. The

次要结局

  • Change in Number of Spontaneous Complete Bowel Movements(Up to 10 weeks)
  • Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale(Up to 10 weeks)
  • Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey(Up to 10 weeks)
  • Change in the Patient Assessment of Constipation (PAC-SYN) Score(Up to 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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