Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Johns Hopkins University

Status: Completed

Conditions: Gastroparesis; Scleroderma

Treatments: Device: transcutaneous electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03294616

IRB00089514

Details and patient eligibility

About

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 .

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• History of any systemic diseases or surgeries;
• allergic to adhesives; pregnancy;
• unable to sign the consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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23 participants in 3 patient groups

scleroderma patients-0

Experimental group

Description:

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).

Treatment:

Device: transcutaneous electroacupuncture

scleroderma patient-1

Experimental group

Description:

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.

Treatment:

Device: transcutaneous electroacupuncture

scleroderma patients-2

Experimental group

Description:

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.

Treatment:

Device: transcutaneous electroacupuncture