About this trial
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 criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Transcutaneous Electrical Acustimulation (TEA)
- Sham-TEA
Treatment groups
Sponsors and collaborators
The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator