The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
研究概览
简要总结
The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •at least 3 episodes of heartburn and/or regurgitation in a week for at least 3 months.
- •evidence for an abnormal esophagal acid exposure on impedance-pH monitoring (tested in the last 2 years off PPI)
排除标准
- •gastric or esophagal surgery
- •active peptic ulcer disease
- •malignancy
- •pregnancy
- •uncontrolled diabetes mellitus
- •severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker/defibrillator
- •allergy to adhesives/patches
- •severe pulmonary disease
- •obesity (BMI>30)
研究组 & 干预措施
Protocol #1
interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium
干预措施: TENS (Device)
Protocol #2
1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium
干预措施: TENS (Device)
Protocol #3
1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique
干预措施: TENS (Device)
Protocol #4
1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium
干预措施: TENS (Device)
结局指标
主要结局
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
时间窗: 34 days
次要结局
- Esophageal acid exposure before and after treatment(34 days)
研究者
Ram Dickman
Gastroenterologist, manager of the GI movement service in RMC
Rabin Medical Center