Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Connecticut

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • IBS-PPSM intervention

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Connecticut

Lead sponsor

Yale University

Collaborator