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| Name | Class |
|---|---|
| Yale University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS-PPSM intervention group | Experimental | After the baseline visit, the IBS-PPSM group will receive 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. The IBS-PPSM group will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data. |
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| IBS-control group | No Intervention | The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBS-PPSM 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity and interference | 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. | Baseline and 4-week follow-up; Weekly Online Logs |
| IBS-related symptoms | Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data. | Baseline and 4-week follow-up; Weekly Online Logs |
| Electrodermal activity (EDA) | EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS | Baseline and 4-week follow-up |
| Electrocardiogram (ECG) | ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV | Baseline and 4-week follow-up |
| Electromyogram (EMG) | EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV | Baseline and 4-week follow-up |
| Objective integrated multimodal electrophysiological index | 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. | Baseline and 4-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugo F Posada-Quintero | Contact | 8604861556 | hugo.posada-quintero@uconn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vernon Cottage, Depot Campus | Recruiting | Storrs | Connecticut | 06269 | United States |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D059265 | Visceral Pain |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized controlled ambulatory trial
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| D012817 | Signs and Symptoms, Digestive |
| D059226 | Nociceptive Pain |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |