Health Trials

About this trial

The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is:

To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.

Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.

Eligibility criteria

Qualifiers

Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.

Age >= 18 years

English speaking.

Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0

Disqualifiers

Pregnancy, or currently lactating.

A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)

Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.

Known allergy to adhesive ECG electrodes.

Trial design

Treatments tested in this trial

  • Transcutaneous Electrical Nerve Stimulation

Treatment groups

16 Participants
are divided into 1 treatment group

Locations

1
University of Michigan48912, Ann ArborMichigan, United States

Sponsors and collaborators

University of Michigan

Lead sponsor

Source ClinicalTrials.gov