Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
This study examines a new method to measure pain using body signals like heart rate, skin response, and muscle activity in people with irritable bowel syndrome (IBS) and healthy volunteers. Researchers will record these signals while participants experience different types of pain to develop a more objective way to assess pain levels.
Key Objective: This trial aims to create a reliable, objective tool to measure visceral pain that could improve how doctors assess and treat abdominal pain conditions.
Who to Consider: People with irritable bowel syndrome or those with abdominal pain who are interested in contributing to research that may improve pain measurement and treatment should consider enrolling.
Trial Parameters
Brief Summary
The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.
Eligibility Criteria
Inclusion Criteria: * Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain. * Men and women 18-50 years old * Able to read and speak English * Daily access to a computer with internet access. Exclusion Criteria: * Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc. * Celiac disease or inflammatory bowel disease * Diabetes mellitus; d) Serious mental health conditions * Women during pregnancy or within 3 months post-partum period * Self- reported Regular use of opioids or other illicit substances. * Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.