Transcutaneous Electrical Nerve Stimulation in Scleroderma
University of Michigan
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, appendect…
Interventions
- DeviceTranscutaneous Electrical Nerve Stimulation
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Location
- University of MichiganAnn Arbor, Michigan