Pain in Patients With Crohn Disease (PAINCD)

Pain Clinical Trial

— PAINCD  

Official title:

Epidemiology and Characterization of Pain in Patients With Crohn Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04488146
• Other study ID #: PAINCD
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: February 2021

Study information

• Verified date: July 2020
• Source: University of Liege
• Contact: Jean L Joris, M.D.
• Phone: +32-4-3667180
• Email: jean.joris[@]chuliege.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Depression, Anxiety
• Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Zeitz J, Ak M, Müller-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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity in patients with Crohn Disease (CD)	Pain intensity measured using a 100 mm visual analog scale (0 = no pain; 100 the worst imaginable pain)	During the last 30 days
Secondary	Presence of hyperalgesia	Using Von Frey hairs (size 2.83 for dectection of allodynia; size 6.65 for temporal somation)	During the last 30 days
Secondary	Search for a neuropathic component of pain	Using DN-4 questionnaires : a score = 3 = neuropathic component	During the last 30 days
Secondary	Investigation of the impact of pain on depression and anxietey	Using the HAD (Hospital anxiety depression) scale : as score > 11 = true symptomatology	During the last 30 days