Pain in Patients With Crohn Disease (PAINCD)

• Conditions: Pain; Depression, Anxiety; Crohn Disease

• Registration Number: NCT04488146
• Lead Sponsor: University of Liege

Brief Summary

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

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 Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27
• Study Start: 2020-10
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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