Clinical trial NCT03332537: Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome
Official title: Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Young Adults
IBS
Self Management
Pain
Gut microbiome
Genetics
Online education
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain sensitivity
timeFrame: Baseline and 6 weeks and 12 weeks
measure: Change in gut microbiome
timeFrame: Baseline and 6 weeks and 12 weeks
Secondary outcomes:
measure: Genetic variations (Pain-susceptibility SNPs genotyping)
timeFrame: Baseline
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health Center
state: Connecticut
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Xiaomei Cong, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen J, Zhang Y, Barandouzi ZA, Lee J, Zhao T, Xu W, Chen MH, Feng B, Starkweather A, Cong X. The effect of self-management online modules plus nurse-led support on pain and quality of life among young adults with irritable bowel syndrome: A randomized controlled trial. Int J Nurs Stud. 2022 Aug;132:104278. doi: 10.1016/j.ijnurstu.2022.104278. Epub 2022 Apr 30.