<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488146</url>
  </required_header>
  <id_info>
    <org_study_id>PAINCD</org_study_id>
    <nct_id>NCT04488146</nct_id>
  </id_info>
  <brief_title>Pain in Patients With Crohn Disease (PAINCD)</brief_title>
  <acronym>PAINCD</acronym>
  <official_title>Epidemiology and Characterization of Pain in Patients With Crohn Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominal pain is a common symptom in patients with Crohn disease (CD). Pain is&#xD;
      multifactorial, may result from inflammation but persists in many patients during remission.&#xD;
&#xD;
      The aim of our study is to determine the epidemiology of pain in CD patients and define the&#xD;
      characteristics of pain : localisation, temporal and sensorial characteristics, neuropathic&#xD;
      component, impact on quality of life and mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD) that&#xD;
      alters quality of life and can lead to increased healthcare utilization. In addition to&#xD;
      abdominal pain, pain can result from extra-intestinal manifestation of IBD. 40% of IBD&#xD;
      patients suffer from extra-intestinal manifestations. Although abdominal pain has been&#xD;
      traditionally attributed to inflammation, functional abdominal pain exists in patients with&#xD;
      IBD, associated with a variety of potential causes. About 20-40% of patients in complete&#xD;
      clinical and endoscopic remission continue to experience chronic pain. Thus, when examining&#xD;
      an IBD patient with abdominal pain, in addition to IBD-related complications (e.g.,&#xD;
      inflammation, stricture), it is important to screen for other contributors, including&#xD;
      peripheral factors (visceral hypersensitivity, bacterial overgrowth, and bowel dysmotility)&#xD;
      and centrally mediated neurobiological and psychosocial underpinnings. These central factors&#xD;
      include psychological symptoms, sleep disturbance, and stress. Opioid-induced hyperalgesia&#xD;
      (e.g., narcotic bowel syndrome) is also growing in recognition as a potential central source&#xD;
      of abdominal pain.&#xD;
&#xD;
      Pronounced severe pain impacts health related quality of life (QoL). Longstanding pain leads&#xD;
      to decreased QoL, increase in pain medication intake, and co-morbidities including&#xD;
      depression, anxiety and even addiction. Furthermore, pain attacks severely interfere with&#xD;
      social and professional life.&#xD;
&#xD;
      Knowledge of these potential aetiologies should be used to individualize treatment of&#xD;
      abdominal pain in patients with IBD. Accurate assessment of the source of pain can help guide&#xD;
      appropriate diagnosis workup and use of modifying therapy.&#xD;
&#xD;
      The aim of the study is to determine the epidemiology of pain in patients with Crohn disease&#xD;
      (CD) and to characterize their pain (localisation, temporal characteristics, acute vs.&#xD;
      chronic, sensorial characteristics, existence of neuropathic component, existence of&#xD;
      hyperalgesia), and their impact of QoL, depression and anxiety&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity in patients with Crohn Disease (CD)</measure>
    <time_frame>During the last 30 days</time_frame>
    <description>Pain intensity measured using a 100 mm visual analog scale (0 = no pain; 100 the worst imaginable pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of hyperalgesia</measure>
    <time_frame>During the last 30 days</time_frame>
    <description>Using Von Frey hairs (size 2.83 for dectection of allodynia; size 6.65 for temporal somation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Search for a neuropathic component of pain</measure>
    <time_frame>During the last 30 days</time_frame>
    <description>Using DN-4 questionnaires : a score ≥ 3 = neuropathic component</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigation of the impact of pain on depression and anxietey</measure>
    <time_frame>During the last 30 days</time_frame>
    <description>Using the HAD (Hospital anxiety depression) scale : as score &gt; 11 = true symptomatology</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Pain</condition>
  <condition>Depression, Anxiety</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient visiting the multidisciplinary center for inflammatory bowel diseaese chaired&#xD;
        by Prof Edouard Louis at CHU Liège, domaine du Sart Tilman, Liège, Belgium&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient with Crohn disease in remission or relapse period age ≥ 18 yo.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria beside no informed consent and inadequate French language skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-François Brichant, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Liege, Domaine du Sart Tilman, Liege, Belgium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean L Joris, M.D.</last_name>
    <phone>+32-4-3667180</phone>
    <email>jean.joris@chuliege.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pierre-Yves Hardy, M.D</last_name>
    <phone>+32-4-3667180</phone>
    <email>pyhardy@student.uliege.be</email>
  </overall_contact_backup>
  <results_reference>
    <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.</citation>
    <PMID>25208108</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>23524595</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27332879</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Jean François Brichant</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>crohn disease</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488146
org study id: PAINCD
nct id: NCT04488146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Pain intensity in patients with Crohn Disease (CD)
time frame: During the last 30 days
description: Pain intensity measured using a 100 mm visual analog scale (0 = no pain; 100 the worst imaginable pain)
measure: Presence of hyperalgesia
time frame: During the last 30 days
description: Using Von Frey hairs (size 2.83 for dectection of allodynia; size 6.65 for temporal somation)
measure: Search for a neuropathic component of pain
time frame: During the last 30 days
description: Using DN-4 questionnaires : a score ≥ 3 = neuropathic component
measure: Investigation of the impact of pain on depression and anxietey
time frame: During the last 30 days
description: Using the HAD (Hospital anxiety depression) scale : as score > 11 = true symptomatology
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-François Brichant, M.D.
role: Principal Investigator
affiliation: CHU Liege, Domaine du Sart Tilman, Liege, Belgium
last name: Jean L Joris, M.D.
phone: +32-4-3667180
email: jean.joris@chuliege.be
last name: Pierre-Yves Hardy, M.D
phone: +32-4-3667180
email: pyhardy@student.uliege.be
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.
PMID: 25208108
citation: 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.
PMID: 23524595
citation: 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.
PMID: 27332879
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Jean François Brichant
investigator title: Professor of Anesthesiology
mesh term: Crohn Disease
sharing ipd: No