Studying How Electrical Stimulation Affects Constipation in Adults with Systemic Sclerosis

What this Trial Is About

Researchers are studying whether transcutaneous electrical acustimulation TEA can change colon and anorectal function related to systemic sclerosis SSc, a condition that can cause constipation. The study focuses on how TEA may improve nerve system function, slow colonic transit SCT, rectal hyposensitivity RH, autonomic dysfunction, and inflammatory pathways in people with SSc-related constipation. Participants will be randomly assigned to receive either TEA or a sham placebo version of TEA. Both treatments are applied as a device worn for 1 hour, twice daily, over a 4-week period. The study uses a quadruple masking design to compare these two groups and assess their effects on the condition. During the study, participants will undergo evaluations at the start and after 4 weeks, including tests for colonic transit time, rectal sensitivity, autonomic nervous system function using heart rate variability and questionnaires, and inflammatory markers in the blood. The main measurement is the change in slow colonic transit after 4 weeks. The total participation time includes baseline and week 4 visits.

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis