Transcutaneous Electrical Acustimulation (TEA) for the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD): A Multicenter, Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Title Proportion of 24-Hour Heartburn-Free Days During the 4-Week Treatment Period
研究概览
简要总结
This multicenter study aims to evaluate whether Transcutaneous Electrical Acustimulation (TEA) is effective in treating Non-Erosive Gastroesophageal Reflux Disease (NERD). NERD is a common condition where patients experience symptoms like heartburn and regurgitation, but no visible damage can be seen in the esophagus during an endoscopy. TEA is a non-invasive treatment that uses a small device to deliver mild electrical stimulation through the skin on specific acupoints. This study will compare the effects of real TEA treatment with a sham (inactive) control. Participants will be randomly assigned to one of two groups: active TEA treatment or sham stimulation. Neither the participants nor the researchers evaluating the outcomes will know which treatment is being given. The main outcome is the improvement of reflux symptoms after 4 weeks of treatment. The results of this study may provide a new non-drug option for patients suffering from NERD.
详细描述
Study Design
This is a prospective, multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial conducted at multiple centers in China. A total of 204 eligible participants with non-erosive gastroesophageal reflux disease (NERD) will be enrolled and randomly assigned in a 1:1 ratio to receive either active transcutaneous electrical acustimulation (TEA) or sham stimulation for 4 weeks. Randomization will be performed centrally using a computer-generated permuted block design (fixed block size of 4), stratified by study site. Due to differences in stimulation location, treatment administrators will be aware of group assignment; however, participants, outcome assessors, and data analysts will remain blinded to treatment allocation. Group labels (Group A / Group B) will be used in the electronic case report form (eCRF) to maintain blinding.
Study Population
Participants will be recruited from gastroenterology clinics. Eligible participants must meet all of the following criteria: age 18-75 years; typical heartburn symptoms for ≥3 months; heartburn on ≥2 days during the run-in diary period; endoscopically confirmed NERD (no esophageal erosions, Los Angeles grade N/M) within 12 months; and willingness to discontinue acid-suppressive therapy during the study. Key exclusion criteria include familiarity with acupuncture points, presence of esophageal structural or mucosal diseases (e.g., Barrett's esophagus, erosive esophagitis LA grade A-D), gastric or duodenal ulcers, functional heartburn or dyspepsia by Rome IV criteria, uncontrolled systemic diseases, implanted electronic devices (e.g., pacemaker), pregnancy, and participation in other interventional trials within the past 3 months.
All enrolled participants will be categorized based on heartburn frequency during the baseline run-in period (electronic diary) into two subgroups: Subgroup A (heartburn ≥4 days/week) and Subgroup B (heartburn 2-3 days/week). This stratification will be used for prespecified subgroup analyses to explore potential differences in treatment effects across symptom frequency populations.
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
- Triple (Participant, 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
- •Age 18-75 years, irrespective of gender
- •Typical heartburn symptoms for at least 3 months
- •Heartburn on at least 2 days during the run-in diary period
- •Endoscopically confirmed NERD (no esophageal erosions, Los Angeles grade N or M) within 12 months
- •Willingness and ability to comply with all study procedures and to provide written informed consent
排除标准
- •Familiarity with acupuncture points and their functions (e.g., previous acupuncture experience or medical training)
- •Any esophageal structural or mucosal disease (e.g., Barrett's esophagus, erosive esophagitis LA grade A-D, eosinophilic esophagitis, esophageal stricture, varices, malignancy, or prior chemical/thermal/radiation injury)
- •Presence of gastric or duodenal ulcers
- •History of or suspected diagnosis of functional heartburn or functional dyspepsia by Rome IV criteria
- •Systemic diseases affecting gastrointestinal motility (e.g., systemic sclerosis, dermatomyositis, systemic lupus erythematosus, amyloidosis), uncontrolled diabetes mellitus (fasting glucose ≥11.1 mmol/L or glycated hemoglobin ≥7.0%), severe cardiovascular disease, significant hepatic or renal dysfunction, or severe psychiatric disorders
- •Inability to discontinue prohibited medications (PPIs, P-CABs, H2RAs, prokinetics, or other GERD-directed therapies) except for protocol-defined rescue medication during the study
- •Implanted electronic devices (e.g., pacemaker, defibrillator) or other implants susceptible to electrical stimulation
- •Local skin disease or severe hypersensitivity at stimulation sites
- •Pregnancy, breastfeeding, or planned pregnancy during the study period
- •Participation in other interventional clinical trials within the past 3 months
研究组 & 干预措施
ST36 TEA Group
Participants receive active transcutaneous electrical acustimulation (TEA) at the ST36 (Zusanli) acupoint unilaterally.
干预措施: Transcutaneous Electrical Acustimulation (Device)
Sham TEA Group
Participants receive sham transcutaneous electrical acustimulation (TEA) with electrodes placed unilaterally at the olecranon and 3-5 cm vertically down from the olecranon.
干预措施: Transcutaneous Electrical Acustimulation (Device)
结局指标
主要结局
Title Proportion of 24-Hour Heartburn-Free Days During the 4-Week Treatment Period
时间窗: Day 1 to Day 28 (the 4-week treatment period)
Description Heartburn is defined as a sensation of warmth, burning, or acid-burning discomfort in the substernal or epigastric region. Heartburn severity is assessed using a 0-3 scale: 0=none; 1=mild (noticed but does not affect activities); 2=moderate (interferes with daily activities); 3=severe (significantly affects daily life or sleep). A heartburn-free day is defined as a day meeting both of the following criteria: heartburn score = 0 on that day, and no use of rescue antacids on that day. The proportion of heartburn-free days is calculated as (number of heartburn-free days) / (number of valid observation days) during the 4-week treatment period.
次要结局
- Weekly Proportion of 24-Hour Heartburn-Free Days During Treatment(Week 1, Week 2, Week 3, and Week 4 of the treatment period)
- Title Change from Baseline in GERD-Q Total Score(Baseline (Week 0), Week 4 (end of treatment), and Week 8 (end of follow-up))
- Title Change from Baseline in GERD-HRQL Total Score(Baseline (Week 0), Week 4 (end of treatment), and Week 8 (end of follow-up))
- Rescue Medication Use(During the 4-week treatment period (Week 0 to Week 4))
- Persistence of Efficacy After TEA Discontinuation(Last week of follow-up period (Week 8))
- Patient Global Impression of Change and Treatment Acceptability(Week 4 (PGI-C) and Week 8 (treatment acceptability))
- Overall Safety Profile of TEA(From Week 0 to Week 8 (entire study period))