What this study is
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.
What's being tested
- IBS-PPSM intervention
Intervention · BEHAVIORAL
IBS-PPSM intervention includes 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting.
Study details
- Official title
- OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
- Sponsor
- University of Connecticut
- Conditions
- Abdominal Pain
- Enrolling
- 120 people
- Starts
- 2025-09-08
- Est. completion
- 2029-02-28
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVernon Cottage, Depot Campus
Storrs, Connecticut, United States
- Maria Groza · Contact573-529-9499maria.groza@uconn.edu
- Stephen Kenton · Contactkenton@easternct.edu
Recruiting
Study team
Sponsor
University of Connecticut
Study ID B2023-0046
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.