Crohn DiseasePAINCDNCT04488146
Pain in Patients With Crohn Disease (PAINCD)
An observational study of Crohn Disease and Pain, run by University of Liege.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Pain, Depression, Anxiety
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- any patient with Crohn disease in remission or relapse period age ≥ 18 yo.
Who cannot join
- No exclusion criteria beside no informed consent and inadequate French language skills
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Crohn Disease, Pain, Depression, Anxiety
- Keywords
- crohn disease, pain
- Medical subject headings
- Crohn Disease, Pain, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the last 30 days
Secondary outcomes (3)
Presence of hyperalgesia
Using Von Frey hairs (size 2.83 for dectection of allodynia; size 6.65 for temporal somation)
Measured: During the last 30 days
Search for a neuropathic component of pain
Using DN-4 questionnaires : a score ≥ 3 = neuropathic component
Measured: During the last 30 days
Investigation of the impact of pain on depression and anxietey
Using the HAD (Hospital anxiety depression) scale : as score > 11 = true symptomatology
Measured: During the last 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study startOct 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
- Investigators
- Jean-François Brichant, M.D., Principal investigator, CHU Liege, Domaine du Sart Tilman, Liege, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488146
- Sponsor's protocol ID
- PAINCD
- Acronym
- PAINCD
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25208108Morrison 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.
PubMed 23524595Zeitz 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.
PubMed 27332879Hardy 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.
PubMed 35380673
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Characterization of Pain in Patients With Crohn Disease
- ClinicalTrials.gov ID
- NCT04488146
- Acronym / sponsor ID
- PAINCD / PAINCD
- Conditions
- Crohn Disease, Pain, Depression, Anxiety
- Keywords
- crohn disease, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- any patient with Crohn disease in remission or relapse period age ≥ 18 yo.
Key exclusion criteria (1 listed)
- No exclusion criteria beside no informed consent and inadequate French language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Presence of hyperalgesia
Time frame: During the last 30 days
Search for a neuropathic component of pain
Time frame: During the last 30 days
Investigation of the impact of pain on depression and anxietey
Time frame: During the last 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Results publication: PubMed 25208108Srinath 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.
- Results publication: PubMed 23524595Morrison 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.
- Results publication: PubMed 27332879Zeitz 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.
- Derived from this study: PubMed 35380673Hardy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Brichant, M.D. principal investigator
CHU Liege, Domaine du Sart Tilman, Liege, Belgium
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Pain, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean L Joris, M.D. (+32-4-3667180, jean.joris@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity in patients with Crohn Disease (CD) (time frame: During the last 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488146, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.