Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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This pilot project will provide foundational information about the contextual factors of irritable bowel syndrome (IBS) related pain (pain catastrophizing, perceived stress, reactivity pain sensitivity, genetic and microbiome) on pain self-management (SM) process and outcomes. In addition, the investigators will gain insight on the potential impact of the personalized IBS-pain SM approach on pain SM behaviors and health outcomes.

Detailed Description
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Intense, recurrent abdominal (visceral) pain is a predominant symptom of irritable bowel syndrome (IBS), a functional gut disorder that typically manifests in the early adult years. IBS is common with prevalence reaching over 20% in some regions of the world, and affects more women than men. While women report more severe IBS-related pain, both younger men and women report more severe pain compared to older adult cohorts. Direct costs of care and lost productivity in the U.S. exceed $21 billion annually, and individuals with IBS utilize more healthcare services than the general population, including outpatient visits, diagnostic testing and over-the-counter and prescription medications. Individuals with IBS report that pain is the most distressing symptom and has the greatest impact on quality of life, however, current approaches to improve self- management of IBS-related pain do not target individual, context-specific factors of pain. Therefore, individuals with IBS-related pain often endure a long and frustrating course of learning how to manage pain on their own accord. The proposed pilot project was developed based on this common situation and will provide feasibility data about the influence of providing a personalized pain SM intervention to individuals with IBS-related pain. IBS-related pain is associated with sensitization of the central nervous system, and approximately half of all patients with IBS have visceral hypersensitivity. These alterations in pain processing escalate pain perception, and can increase vulnerability to other co-morbid pain disorders which individuals with IBS frequently suffer. Pain sensitization is influenced by pain-sensitivity genes and, specific to IBS-related pain, the gut microbiome. Therefore, as contextual factors of pain associated with IBS, the investigators will measure peripheral and central sensitivity, single-nucleotide polymorphisms (SNPs) of candidate pain-sensitivity genes and the gut microbiome. The SM intervention was designed to provide factual information about IBS pain, triggers of pain and pain SM skills. The experimental group will receive one-on-one consultation tailored around the individual's assessment results of peripheral and central pain sensitivity as measured by quantitative sensory testing (QST) and targeted toward increasing pain self-efficacy and self-regulation skills and abilities. The proposed pilot project will provide foundational information about the contextual factors of IBS pain (pain catastrophizing, perceived stress, reactivity pain sensitivity, genetic and microbiome) on pain SM process and outcomes. In addition, the investigators will gain insight on the potential impact of the personalized IBS-pain SM approach on pain SM behaviors and health outcomes.

Official Title
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Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Personalized IBS Pain SM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 18-29 years of age Diagnosis of IBS from a healthcare provider with a current report of pain Able to read and write in English Daily access to a computer connected to the internet Exclusion Criteria: Other chronic painful conditions (i.e. fibromyalgia, chronic pelvic pain, or chronic interstitial cystitis) Infectious disease (hepatitis, HIV, MRSA) Celiac disease or inflammatory bowel disease Diabetes Mellitus Serious mental health conditions (ex. Bipolar disorder, schizophrenia, mania) Women who are pregnant or post-partum in last 3 months Regular use of opioids, iron supplements, prebiotics/probiotics or antibiotics, or substance abuse. Injury to non-dominant hand or presence of open skin lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will be provided an online interactive platform to access electronic modules (total of 10) on: IBS-related pain neurophysiology and the brain-gut axis and self-management strategies. There is no additional intervention. | |
| Experimental: Personalized IBS Pain SM<br>Participants will be enrolled in the online platform. After completion of the modules, they will be scheduled for a consultation with a research nurse about their level of peripheral and central sensitivity, self-evaluation of IBS-pain SM, goal setting and self-monitoring of IBS-pain and physical activity. They will be asked to document their pain and all symptom SM behaviors daily for the next 10 weeks. At the 6-week follow-up visit, the researcher will review the online activities of the participant, go over the previously selected goals with the participants. The study nurse will acknowledge accomplishment of goals and assist in problem-identification and solving. | Behavioral: Personalized IBS Pain SM<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain sensitivity | Quantitative sensory testing - Change over time | Baseline and 6 weeks and 12 weeks | 
| Change in gut microbiome | Change over time | Baseline and 6 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variations (Pain-susceptibility SNPs genotyping) | related to IBS-related pain and gut microbiome | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Young Adults, Self Management, Pain, Gut microbiome, Genetics, Online education