Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
The University of Texas Health Science Center, Houston
60 participants
Feb 17, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.
Eligibility
Inclusion Criteria3
- Patients with SSc-constipation from Aim 1 of the study
- Patients with SCT (\>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)
- Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.
Exclusion Criteria1
- Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
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Interventions
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Locations(1)
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NCT05989763