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

Crohn's Disease Clinical Trial

— Douleur IRMf  

Official title:

Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission: Functional MRI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02874495
• Other study ID #: 38RC11.220
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 16, 2016
• Start date: January 2012
• Est. completion date: April 2017

Study information

• Verified date: August 2016
• Source: University Hospital, Grenoble
• Contact: Bruno Bonaz, Professor
• Phone: 04.76.76.55.97
• Email: BBonaz[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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.

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

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

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Walach H., Buttenmuller, V., Kleinknecht N., Schmidt S. Measuring mindfulness - the Freiburg Mindfulness Inventory (FMI). Personnality and Individual Differences, 2006, 40:1543-1555.

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* Note: There are 87 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging	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.	30 minutes	No
Primary	Heart Rate Variability	During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).	30 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Questionnaire of personality inventory NEO-FFI (Bouvard, 2005)	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Questionnaire of depressive symptomatology CES-D (Center for Epidemiologic Studies-Depression Scale; Radloff, 1977)	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Anxiety inventory (STAI-Y of Spielberger)	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Pain Catastrophizing Scale of Sullivan 1995	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Pain Anxiety Symptoms Scale of Cracken 1992	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Fear of Pain Questionnaire of McNeil andRainwater ; 1998	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Visceral Sensitivity Index of Labus; 2004	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Questionnaire of Mindfulness, Walach 2006	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Questionnaire for uncertainty intolerance (Freeston 1994)	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : The Illness Attitude Scales, Dammen 1999	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Childhood Trauma Questionnaire of Bernstein 2003	45 minutes	No
Primary	Psychological tests	Related to affective and cognitive dimensions of pain : Ways of Coping Checklist Revised, adapted in French by Cousson 1996	45 minutes	No