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Trial record 2 of 3 for:    10889150 [PUBMED-IDS]

Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission (Douleur IRMf)

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ClinicalTrials.gov Identifier: NCT02874495
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

Crohn's disease goes along with an alteration of the quality of life, even in remission and has a negative impact on stress management linked to the pain and the health. Conversely, stress and psychological variables play a significant role in the pathogenesis of this disease. These interrelations reflects the link between the brain and the digestive tract, called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface, relaying in a bidirectional way, informations between the digestive tract and the central nervous system (CNS).

Visceral information can thus modulate the functionnement of CNS's areas involved in pain management but also in the management of emotional and cognitive behaviours. Yet, numerous work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a dysautonomia of the sympatho-vagal balance.

Human brain respond by advance before and during the application of a painful stimulus that enable the organism to regulate its nociceptive system in order to handle the aversive stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain awareness.

The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension and anxiety, that could influence visceral perception (increasing it). Nevertheless, only few studies exists about the differential role of certain or uncertain anticipation of the pain, despite the fact that they are associated to different emotional, cognitive and behavioral responses, and the effect of anticipation on painful visceral perception, have not yet been studied for parents in remission of Crohn's disease.

The main goal is to search during certain and uncertain visceral anticipation, induced by distension of an intra-rectal balloon for persons suffering from Crohn's disease in remission, compared to control subjects, with an MRI functional study


Condition or disease Intervention/treatment
Crohn's Disease Behavioral: Psychological tests Device: Magnetic Resonance Imaging Behavioral: Heart Rate Variability

Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission: Functional MRI Study
Study Start Date : January 2012
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
Healthy volunteers
22 persons.
Behavioral: Psychological tests
Related to affective and cognitive dimensions of pain.

Device: Magnetic Resonance Imaging

With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI.

With measure of heart rate variability.

Other Name: MRI

Behavioral: Heart Rate Variability
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Other Name: HRV

Patients with Crohn's disease
22 patients.
Behavioral: Psychological tests
Related to affective and cognitive dimensions of pain.

Device: Magnetic Resonance Imaging

With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI.

With measure of heart rate variability.

Other Name: MRI

Behavioral: Heart Rate Variability
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Other Name: HRV




Primary Outcome Measures :
  1. Magnetic Resonance Imaging [ Time Frame: 30 minutes ]

    Activation of cortical cerebral structures involved in visceral pain and communication paths between them With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI.

    With measure of heart rate variability.


  2. Heart Rate Variability [ Time Frame: 30 minutes ]
    During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).

  3. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Questionnaire of personality inventory NEO-FFI (Bouvard, 2005)


  4. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Questionnaire of depressive symptomatology CES-D (Center for Epidemiologic Studies-Depression Scale; Radloff, 1977)


  5. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Anxiety inventory (STAI-Y of Spielberger)


  6. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Pain Catastrophizing Scale of Sullivan 1995


  7. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Pain Anxiety Symptoms Scale of Cracken 1992


  8. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Fear of Pain Questionnaire of McNeil andRainwater ; 1998


  9. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Visceral Sensitivity Index of Labus; 2004


  10. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Questionnaire of Mindfulness, Walach 2006


  11. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Questionnaire for uncertainty intolerance (Freeston 1994)


  12. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    The Illness Attitude Scales, Dammen 1999


  13. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Childhood Trauma Questionnaire of Bernstein 2003


  14. Psychological tests [ Time Frame: 45 minutes ]

    Related to affective and cognitive dimensions of pain :

    Ways of Coping Checklist Revised, adapted in French by Cousson 1996




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Crohn's disease
Criteria

Inclusion Criteria:

  • For patients :

    • Patients over 18 years and less than 60 years.
    • Right-handed.
    • Diagnosis of Crohn's disease established on clinical biological, endoscopic and anatomopathological criteria.
    • Ideal localization and/or diarrhea of Crohn's Disease, with an absence of rectal or anoperineal ravages past or presents in order to not do distension on rectal/ and anoperineal lesions.
    • Crohn's disease treatment authorize : 5-aminosalicylates since at least 4 weeks with a stable dose since at least 2 weeks ; immunosuppressive drugs since at least 12 weeks with a stable dose since at least 4 weeks ; anti-TNF since at least 3 months with a stable dose since at least 1 month ; absence of corticosteroid treatment since at least 15 days.
    • Clinical remission : Crohn's Disease Activity Index (CDAI) < 150 (Best 1976) and biological : normal CRP and faecal calprotectin < 100 g/g.
    • Patient able to understand and follow necessary commissions for the conduct of the clinical trial, and that have given his free written consent for this study.
    • Registered to a French social security.
    • The person won't be allow to participate simultaneously to another study and there won't be an exclusion period to participation to a clinical or therapeutic trial at the end of this study.
  • For healthy volunteers

    • Patients over 18 years and less than 60 years.
    • Right-handed.
    • Paired with patients for sex and age.
    • Absence of digestive surgical or medical history except appendectomy, hysterectomy, cholecystectomy, inguinal hernia cure and/or femoral.
    • Absence of digestive symptomatology searched while a standardized interrogation.
    • Clinical digestive exam normal.
    • The person won't be allow to participate simultaneously to another study and there won't be an exclusion period to. participation to a clinical or therapeutic trial at the end of this study.
    • Registered to a French social security.
    • Registered to the national file of persons participating to biomedicals searches without direct individual profit.

Exclusion Criteria:

  • Subjet under 18 years and more than 60 years.
  • Counter-argument for MRI : presence of intra-corporeal ferro-magnetic particles, claustrophobia.
  • Existence of a severe condition on general level (cardiac, respiratory, hematological, renal, hepatic, cancerous).
  • Existence of an organic digestive affection (gastritis, gallstones, duodenal ulcer, megacolon, inflammatory colitis).
  • Existence or history malignant gastrointestinal condition.
  • History of abdominal digestive surgery except appendectomy, hysterectomy, cure of inguinal hernia)
  • Recto-anal or périneal active pathology (haemorrhoid , anal fissure …).
  • Presence of arectal fecal impaction.
  • Patient included in an other clinical or therapeutic trial.
  • Patient treated by a drug sensitive to modify sensitivity and/or digestive motor function.
  • Patient regularly receiving psychotropic drugs (anxiolytics, sedatives, antidepressants, neuroleptics).
  • Patient with a pathology that could modify visceral sensitivity like diabetes or neurodegenerative diseases.
  • Persons concerned by articles L1121-5 to L1121-8 of CSP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874495


Contacts
Contact: Bruno Bonaz, Professor 04.76.76.55.97 BBonaz@chu-grenoble.fr
Contact: Amandine Rubio, Medical doctor 04.76.76.59.11 arubio@chu-grenoble.fr

Locations
France
UniversityHospitalGrenoble Recruiting
La Tronche, France, 38700
Contact: Bruno Bonaz, Professor    04.76.76.55.97    BBonaz@chu-grenoble.fr   
Contact: Amandine Rubio, Medical doctor    04.76.76.59.11    arubio@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Bruno Bonaz, Professor Grenoble Hospital University

Publications:
Ashburner J. Computational anatomy with the SPM software. Magn Reson Imaging. 2009;27(8):1163-74. Epub 2009 Feb 27. Review.Baciu MV, Bonaz BL, Papillon E, Bost RA, Le Bas JF, Fournet J, Segebarth CM. Central processing of rectal pain: a functional MR imaging study. AJNR Am J Neuroradiol. 1999;20(10):1920-4.
Bouvard, M., Cottreaux, J. Protocoles et échelles d'évaluation en psychiatrie et en psychologie. 4ème Ed, 2005 Masson.
Cousson, F, Bruchon-Schweitzer, M, Quintard, B, Nuissier, J, Rascle N. Analyse multidimensionnelle d'une échelle de coping: validation française de la WCC (Ways of Coping Checklist). Psychologie Française 1996 ; 41: 155-164.
Ducrotté P, Bonaz B. Stress et tube digestif dans Stress, Pathologies et Immunité. Thurin JM et Bauman N. Ed Flammarion Médecine-Sciences, 2003 : p181-189.
Freeston, M. H., Rheaume, J., Letarte, H., Dugas, M. J., & Ladouceur, R. Why do people worry? Personality and Individual Differences, 1994, 17, 791-802.
Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas 1977 ; 3 : 385-401.
Spielberger, C.D., Gorsuch, R., Lushene, R. 1983. The State-Trait Personality Inventory (STAI, Form Y), Palo Alto, CA, Consulting Psychologists Press.
Sullivan, M.J.L., Bishop, S. and Pivik, J. The Pain Catastrophizing Scale: Development and validation. Psychol. Assess. 1995, 7: 524-532.
Talairach J and Tournoux P,
Walach H., Buttenmuller, V., Kleinknecht N., Schmidt S. Measuring mindfulness - the Freiburg Mindfulness Inventory (FMI). Personnality and Individual Differences, 2006, 40:1543-1555.

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02874495     History of Changes
Other Study ID Numbers: 38RC11.220
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by University Hospital, Grenoble:
Crohn's disease
Rectal Distension
Remission
Anticipation
Painful

Additional relevant MeSH terms:
Crohn Disease
Dilatation, Pathologic
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical