Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
NCT ID: NCT05989763
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-02-17
2029-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Transcutaneous Electrical Acustimulation (TEA)
Transcutaneous Electrical Acustimulation (TEA)
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham-TEA
Sham-TEA
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Interventions
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Transcutaneous Electrical Acustimulation (TEA)
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham-TEA
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Zsuzsanna Hortobagyi Mcmahan
Associate Professor
Principal Investigators
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Zsuzsanna H McMahan, MD, MHS (M-PI)
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-23-0531
Identifier Type: -
Identifier Source: org_study_id
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