TENS in Scleroderma

Launched by UNIVERSITY OF MICHIGAN · Oct 15, 2024

Keywords

ClinConnect Summary

The clinical trial titled "TENS in Scleroderma" is exploring a new way to help people with Scleroderma who also experience gastroparesis, a condition that makes it hard for the stomach to empty properly. The study is testing a device called a transcutaneous electrical acustimulation (TEA) device, which sends gentle electrical signals through the skin to help relieve uncomfortable symptoms like bloating and distension. Participants will use the device for 45 minutes twice a day after meals and will keep daily diaries and fill out questionnaires every two weeks to track any improvements in their symptoms.

To join this study, participants need to be at least 18 years old, speak English, and have been diagnosed with Systemic Sclerosis, which is a type of Scleroderma, and report moderate to severe bloating symptoms. They should also be on stable stomach-related treatment for at least four weeks. However, some individuals may not be eligible if they are pregnant, have had major abdominal surgery, or have other health conditions that could interfere with the study. This trial is currently recruiting participants and aims to see if the TEA device can be a helpful option for managing Scleroderma-related symptoms.

Gender

ALL

Eligibility criteria

• 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)