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.
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.
None
Parallel
Transcutaneous Electrical Acustimulation (TEA)
DeviceTEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham-TEA
DeviceSham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Change in slow colonic transit (SCT)
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion
Change in rectal hyposensitivity as assessed by the anorectal manometry
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
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The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
