Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
关键词
抽象
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 04/13/2020 |
| 提交的预估入学人数: | 04/13/2020 |
| 首次发布: | 04/15/2020 |
| 上次提交的更新: | 06/15/2020 |
| 最近更新发布: | 06/17/2020 |
| 实际学习开始日期: | 09/30/2020 |
| 预计主要完成日期: | 09/30/2022 |
| 预计完成日期: | 09/30/2022 |
状况或疾病
干预/治疗
Device: Transcutaneous Electroacupuncture
Device: Sham TEA
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: TEA at ST36 and PC6 first and then sham TEA Patients in this group will be treated with TEA at ST36 and PC6 for 4 weeks, followed with a 2-week washout period and another 4-week period with sham TEA. | |
| Experimental: Sham-TEA and then TEA ST36 and PC6 Patients in this group will be treated with sham-TEA for 4 weeks, followed with a 2-week washout period and another 4-week period with TEA at ST36 and PC6. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion criteria for FD patients - Bothersome postprandial fullness - Symptoms of early satiation, epigastric pain, epigastric burning during the last 3 months - No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms. - Males and females between ages 18-80 yrs; - Subjects with high probability for compliance and completion of the study. Inclusion criteria for chronic constipation patients - Satisfying Rome IV criteria for diagnosis of functional constipation; - abdominal X-ray or anorectal manometry test during the past 3 months indicating delayed colonic transit (more than 20% ingested markers are retained) or abnormal colonic motility; - ages 18-80 years; - no constipation medication for a minimum of 1 week before enrollment except for rescue agents (stimulant laxatives, such as bisacodyl); - willing to comply with the treatment regimen. Inclusion criteria for gastroparesis patients - At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms); - Abnormal gastric emptying diagnosed during the past year; - Males and females between ages 18-80 yrs; - Subjects with high probability for compliance and completion of the study. - Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer. Exclusion criteria: - History of gastric bezoar or diverticulitis. - Severe daily abdominal pain requiring narcotic medications. - Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery. - Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy; - Surgery within the past 3 months. - Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test). - Those who have been treated with acupuncture or those who are familiar with acupuncture points. - Anyone with an implantable cardiac pacemaker or defibrillator. - unable to give informed consent; - taking prokinetics, anticholinergic or dopaminergic agents; - history of gastrointestinal surgery; - pregnant or preparing to conceive a child; - diabetes; - allergic to skin preparation. |
结果
主要结果指标
1. Change in the Gastroparesis Cardinal Symptom Index (GCSI) score [Weekly, up to 10 weeks]
2. Change in number of Spontaneous Complete Bowel Movements [Weekly, up to 10 weeks]
3. Change in the Patient Assessment of Constipation (PAC-SYN) score [Every 2 weeks, up to 10 weeks]
次要成果指标
1. Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale [Every 2 weeks, up to 10 weeks]
2. Change in Quality of Life as assessed by the Short Form (SF-36v2) Health Survey [Baseline, week 4, week 6 and week 10]
3. Change in electrogastrogram gastric slow waves [Baseline, week 4, week 6 and week 10]
4. Change in the R - R interval (seconds) [Baseline, week 4, week 6 and week 10]
