Pain in Patients With Crohn Disease (PAINCD) (PAINCD)

July 23, 2020 updated by: Jean François Brichant, University of Liege

Epidemiology and Characterization of Pain in Patients With Crohn Disease

Abdominal pain is a common symptom in patients with Crohn disease (CD). Pain is multifactorial, may result from inflammation but persists in many patients during remission.

The aim of our study is to determine the epidemiology of pain in CD patients and define the characteristics of pain : localisation, temporal and sensorial characteristics, neuropathic component, impact on quality of life and mood.

Study Overview

Status

Unknown

Conditions

Detailed Description

Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD) that alters quality of life and can lead to increased healthcare utilization. In addition to abdominal pain, pain can result from extra-intestinal manifestation of IBD. 40% of IBD patients suffer from extra-intestinal manifestations. Although abdominal pain has been traditionally attributed to inflammation, functional abdominal pain exists in patients with IBD, associated with a variety of potential causes. About 20-40% of patients in complete clinical and endoscopic remission continue to experience chronic pain. Thus, when examining an IBD patient with abdominal pain, in addition to IBD-related complications (e.g., inflammation, stricture), it is important to screen for other contributors, including peripheral factors (visceral hypersensitivity, bacterial overgrowth, and bowel dysmotility) and centrally mediated neurobiological and psychosocial underpinnings. These central factors include psychological symptoms, sleep disturbance, and stress. Opioid-induced hyperalgesia (e.g., narcotic bowel syndrome) is also growing in recognition as a potential central source of abdominal pain.

Pronounced severe pain impacts health related quality of life (QoL). Longstanding pain leads to decreased QoL, increase in pain medication intake, and co-morbidities including depression, anxiety and even addiction. Furthermore, pain attacks severely interfere with social and professional life.

Knowledge of these potential aetiologies should be used to individualize treatment of abdominal pain in patients with IBD. Accurate assessment of the source of pain can help guide appropriate diagnosis workup and use of modifying therapy.

The aim of the study is to determine the epidemiology of pain in patients with Crohn disease (CD) and to characterize their pain (localisation, temporal characteristics, acute vs. chronic, sensorial characteristics, existence of neuropathic component, existence of hyperalgesia), and their impact of QoL, depression and anxiety

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient visiting the multidisciplinary center for inflammatory bowel diseaese chaired by Prof Edouard Louis at CHU Liège, domaine du Sart Tilman, Liège, Belgium

Description

Inclusion Criteria:

  • any patient with Crohn disease in remission or relapse period age ≥ 18 yo.

Exclusion Criteria:

  • No exclusion criteria beside no informed consent and inadequate French language skills

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity in patients with Crohn Disease (CD)
Time Frame: During the last 30 days
Pain intensity measured using a 100 mm visual analog scale (0 = no pain; 100 the worst imaginable pain)
During the last 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of hyperalgesia
Time Frame: During the last 30 days
Using Von Frey hairs (size 2.83 for dectection of allodynia; size 6.65 for temporal somation)
During the last 30 days
Search for a neuropathic component of pain
Time Frame: During the last 30 days
Using DN-4 questionnaires : a score ≥ 3 = neuropathic component
During the last 30 days
Investigation of the impact of pain on depression and anxietey
Time Frame: During the last 30 days
Using the HAD (Hospital anxiety depression) scale : as score > 11 = true symptomatology
During the last 30 days

Collaborators and Investigators

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

Sponsor

University of Liege

Investigators

  • Principal Investigator: Jean-François Brichant, M.D., CHU Liege, Domaine du Sart Tilman, Liege, Belgium

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 (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAINCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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