Abdominal Pain
Conditions
Keywords
visceral pain, irritable bowel syndrome, autonomic and muscular activities, biosignals, personalized pain self-management
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.
Detailed description
In part 1, data collection for training the OIME model, we will collect autonomic and muscular activities with integrated biosignal device and visceral pain level in both healthy controls and IBS participants. These data will be used to train a machine learning model to produce an objective integrated multimodal electrophysiological (OIME) index. In part 2, the ambulatory trial, we will collect data to validate the OIME index as a biomarker of pain in IBS participants. We will run an ambulatory trial to validate the OIME index as a biomarker to assess the treatment of IBS pain.
Interventions
BEHAVIORALIBS-PPSM intervention
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.
Sponsors
Yale University
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
randomized controlled ambulatory trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity and interference | Baseline and 4-week follow-up; Weekly Online Logs | Brief Pain Inventory (BPI) scale: the 9-item scale measures pain intensity and interference using 0 - 10 rating scales. Higher score indicates higher levels of pain intensity and interference. |
| IBS-related symptoms | Baseline and 4-week follow-up; Weekly Online Logs | Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data. |
| Electrodermal activity (EDA) | Baseline and 4-week follow-up | EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS |
| Electrocardiogram (ECG) | Baseline and 4-week follow-up | ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV |
| Electromyogram (EMG) | Baseline and 4-week follow-up | EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV |
| Objective integrated multimodal electrophysiological index | Baseline and 4-week follow-up | Objective integrated multimodal electrophysiological (OIME) index as a biomarker for visceral pain will be generated and validated through integration of surface bio-signal recordings of EDA, ECG, and EMG via a supervised machine-learning algorithm. |
Countries
United States
Contacts
Primary ContactHugo F Posada-Quintero
Outcome results
None listed