Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome
Status: | Active, not recruiting |
---|---|
Conditions: | Irritable Bowel Syndrome (IBS) |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 29 |
Updated: | 10/31/2018 |
Start Date: | October 1, 2016 |
End Date: | December 31, 2018 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Farmington, Connecticut 06030
Principal Investigator: Xiaomei Cong, PhD, RN
Phone: 860-486-2694
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Storrs, Connecticut 06269
Principal Investigator: Xiaomei Cong, PhD, RN
Phone: 860-486-2694
Click here to add this to my saved trials