Pain in Patients With Crohn Disease (PAINCD)

NCT ID: NCT04488146

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Pain Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* any patient with Crohn disease in remission or relapse period age ≥ 18 yo.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Liege

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jean François Brichant

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-François Brichant, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHU Liege, Domaine du Sart Tilman, Liege, Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean L Joris, M.D.

Role: CONTACT

+32-4-3667180

Pierre-Yves Hardy, M.D

Role: CONTACT

+32-4-3667180

References

Explore related publications, articles, or registry entries linked to this study.

Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis. 2014 Dec;20(12):2433-49. doi: 10.1097/MIB.0000000000000170.

Reference Type RESULT
PMID: 25208108 (View on PubMed)

Morrison G, Van Langenberg DR, Gibson SJ, Gibson PR. Chronic pain in inflammatory bowel disease: characteristics and associations of a hospital-based cohort. Inflamm Bowel Dis. 2013 May;19(6):1210-7. doi: 10.1097/MIB.0b013e318280e729.

Reference Type RESULT
PMID: 23524595 (View on PubMed)

Zeitz J, Ak M, Muller-Mottet S, Scharl S, Biedermann L, Fournier N, Frei P, Pittet V, Scharl M, Fried M, Rogler G, Vavricka S; Swiss IBD Cohort Study Group. Pain in IBD Patients: Very Frequent and Frequently Insufficiently Taken into Account. PLoS One. 2016 Jun 22;11(6):e0156666. doi: 10.1371/journal.pone.0156666. eCollection 2016.

Reference Type RESULT
PMID: 27332879 (View on PubMed)

Hardy PY, Fikri J, Libbrecht D, Louis E, Joris J. Pain Characteristics in Patients with Inflammatory Bowel Disease: A Monocentric Cross-Sectional Study. J Crohns Colitis. 2022 Sep 8;16(9):1363-1371. doi: 10.1093/ecco-jcc/jjac051.

Reference Type DERIVED
PMID: 35380673 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PAINCD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endomicroscopy in IBD Patients
NCT01417728 COMPLETED