Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome (IBS-SM)

May 31, 2019 updated by: Xiaomei Cong, University of Connecticut
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UCONN Health Center
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain sensitivity
Time Frame: Baseline and 6 weeks and 12 weeks
Quantitative sensory testing - Change over time
Baseline and 6 weeks and 12 weeks
Change in gut microbiome
Time Frame: Baseline and 6 weeks and 12 weeks
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)
Time Frame: Baseline
related to IBS-related pain and gut microbiome
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Xiaomei Cong, PhD, RN, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H16-152
  • 1P20NR016605-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website.

When will data be available (start and end dates)? Immediately. No end date.

With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov.

By what mechanism will data be made available? Data are available at cdRNS.nih.gov

IPD Sharing Time Frame

within 2 years

IPD Sharing Access Criteria

Requests will be submitted through the cdRNS website

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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