Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
University of Michigan
Summary
This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.
Description
The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C). The study also aims to compare the electrical neuromodulation therapy (TEA) with medical neuromodulation therapy (escitalopram) in their ability to treat abdominal pain and improve the autonomic dysfunction in participants with IBS-C. This project will investigate the impact of 3 active treatment interventions vs. a sham control intervention on abdominal pain and other IBS symptoms in participants with IBS-C. This is a parallel-group study in which the partic…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C) * Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period * Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis. * Abdominal pain is not adequately relieved at the time of screening and the time of randomization. Exclusion Criteria: * Unrelated active disorder which may involve abdo…
Interventions
- DeviceTEA
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
- DrugLexapro
This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
Location
- University of MichiganAnn Arbor, Michigan