Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03294616

Enrollment

Registered

2017-09-27

Start date

2017-02-06

Completion date

2019-11-20

Last updated

2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis, Scleroderma

Keywords

transcutaneous electroacupuncture

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 .

Interventions

DEVICEtranscutaneous electroacupuncture

Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	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

Secondary

Measure	Time frame	Description
effects of TEA on gastric motility	1 week	visit 1 in acute phase; gastric slow waves recording
effects of TEA on autonomic function	1 week	visit 1 in acute phase; heart rate variability recording
effects of TEA on GI hormones and inflammatory cytokine	1 day	baseline before the study; vasoactive intestinal peptide (VIP)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026