Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
- Conditions
- SclerodermaGastroparesis
- Interventions
- Device: transcutaneous electroacupuncture
- Registration Number
- NCT03294616
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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.
- History of any systemic diseases or surgeries;
- allergic to adhesives; pregnancy;
- unable to sign the consent form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description scleroderma patient-1 transcutaneous electroacupuncture 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. scleroderma patients-0 transcutaneous electroacupuncture 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). scleroderma patients-2 transcutaneous electroacupuncture 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.
- Primary Outcome Measures
Name Time Method effect of TEA on symptoms in Systemic Sclerosis (SSc) patients 70 days a validated method including 9 symptoms will be used to assess GI symptoms
- Secondary Outcome Measures
Name Time Method effects of TEA on autonomic function 70 days 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on GI hormones and inflammatory cytokine 70 days 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on gastric motility 70 days visit 4 in chronic phase; breath test will be used to assess gastric emptying
Trial Locations
- Locations (1)
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States