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Could a skin patch ease stomach pain in scleroderma?

NCT ID NCT06646913

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This pilot study tests whether a transcutaneous electrical nerve stimulation (TENS) device is acceptable and helpful for people with scleroderma who experience gastroparesis symptoms like bloating and distension. Participants use the device for 45 minutes twice daily after meals over four weeks, then track symptoms through diaries and questionnaires. The goal is to see if this non-invasive approach can ease digestive discomfort and whether people can stick with it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous electrical nerve stimulation (TENS) device
What this could lead to
If it works, this could offer a drug-free, at-home option to ease bloating and discomfort in people with scleroderma-related gastroparesis.
What could go wrong
This is a small pilot study focused on whether people will use the device, not proof of effectiveness. Results may not apply broadly, and symptom relief is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria. 2. Age \>= 18 years 3. English speaking. 4. Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0 5. Stable GI specific therapy including prokinetics over the last 4 weeks. Exclusion Criteria: 1. Pregnancy, or currently lactating. 2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators) 3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease. 4. Known allergy to adhesive ECG electrodes. 5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma gastroparesis scleroderma systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroparesis Scleroderma Systemic sclerosis (SSC)

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48912, United States

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