Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
研究概览
简要总结
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No any systemic diseases;
- •no scleroderma; no history of gastrointestinal surgery;
- •no dyspeptic symptoms during the past 2 weeks;
- •not taking any medications except contraceptives during the past 2 weeks;
- •age 18 and older.
排除标准
- •History of any systemic diseases or surgeries;
- •allergic to adhesives; pregnancy;
- •unable to sign the consent form.
研究组 & 干预措施
scleroderma patients-0
for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
干预措施: transcutaneous electroacupuncture (Device)
scleroderma patient-1
for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
干预措施: transcutaneous electroacupuncture (Device)
scleroderma patients-2
for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
干预措施: transcutaneous electroacupuncture (Device)
结局指标
主要结局
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
时间窗: 70 days
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
时间窗: 1 day
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
时间窗: 28 days
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
时间窗: 42 days
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
次要结局
- effects of TEA on gastric motility(70 days)
- effects of TEA on autonomic function(70 days)
- effects of TEA on GI hormones and inflammatory cytokine(70 days)
- effects of TEA on gastric motility(1 week)
- effects of TEA on gastric motility(2 weeks)
- effects of TEA on gastric motility(3 weeks)
- effects of TEA on gastric motility(4 weeks)
- effects of TEA on autonomic function(1 week)
- effects of TEA on autonomic function(2 weeks)
- effects of TEA on autonomic function(3 weeks)
- effects of TEA on autonomic function(4 weeks)
- effects of TEA on gastric motility(1 day)
- effects of TEA on gastric motility(28 days)
- effects of TEA on gastric motility(42 days)
- effects of TEA on autonomic function(1 day)
- effects of TEA on autonomic function(28 days)
- effects of TEA on autonomic function(42 days)
- effects of TEA on GI hormones and inflammatory cytokine(1 day)
- effects of TEA on GI hormones and inflammatory cytokine(28 days)
- effects of TEA on GI hormones and inflammatory cytokine(42 days)
- effects of TEA on GI hormones and inflammatory cytokine(day 1)