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RECRUITINGPhase 1INTERVENTIONAL

TENS in Scleroderma

Transcutaneous Electrical Nerve Stimulation in Scleroderma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DEVICE

Transcutaneous Electrical Nerve Stimulation

Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.

Locations (1)

University of Michigan
Ann Arbor, Michigan, United States