Anticipation Effect on Painful Phenomenons Linked to Rectal Distension for Patients With a Crohn's Disease in Remission
NCT ID: NCT02874495
Last Updated: 2016-08-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
44 participants
Study Classification
OBSERVATIONAL
Study Start Date
2012-01-31
Study Completion Date
2017-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early MRI Prediction of Crohns
NCT03340519
Crohn Disease
COMPLETED
DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease
NCT05354609
Crohn Disease
Bowel Cleansing
Apparent Diffusion Coefficient
ACTIVE_NOT_RECRUITING
NA
Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease
NCT02504255
Crohn Disease
COMPLETED
Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
NCT02883296
Anal Fistula
Crohn's Disease
COMPLETED
NA
CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease
NCT01183403
Crohn's Disease
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Crohn's Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy volunteers
22 persons.
Psychological tests
Intervention Type
BEHAVIORAL
Related to affective and cognitive dimensions of pain.
Magnetic Resonance Imaging
Intervention Type
DEVICE
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.
Heart Rate Variability
Intervention Type
BEHAVIORAL
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Patients with Crohn's disease
22 patients.
Psychological tests
Intervention Type
BEHAVIORAL
Related to affective and cognitive dimensions of pain.
Magnetic Resonance Imaging
Intervention Type
DEVICE
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.
Heart Rate Variability
Intervention Type
BEHAVIORAL
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psychological tests
Related to affective and cognitive dimensions of pain.
Intervention Type
BEHAVIORAL
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.
Intervention Type
DEVICE
Heart Rate Variability
During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
Intervention Type
BEHAVIORAL
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
MRI
HRV
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruno Bonaz, Professor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UniversityHospitalGrenoble
La Tronche, , France
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
France
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Pellissier S, Dantzer C, Canini F, Mathieu N, Bonaz B. Psychological adjustment and autonomic disturbances in inflammatory bowel diseases and irritable bowel syndrome. Psychoneuroendocrinology. 2010 Jun;35(5):653-62. doi: 10.1016/j.psyneuen.2009.10.004. Epub 2009 Nov 11.
Reference Type
BACKGROUND
Persoons P, Vermeire S, Demyttenaere K, Fischler B, Vandenberghe J, Van Oudenhove L, Pierik M, Hlavaty T, Van Assche G, Noman M, Rutgeerts P. The impact of major depressive disorder on the short- and long-term outcome of Crohn's disease treatment with infliximab. Aliment Pharmacol Ther. 2005 Jul 15;22(2):101-10. doi: 10.1111/j.1365-2036.2005.02535.x.
Reference Type
BACKGROUND
Petrak F, Hardt J, Clement T, Borner N, Egle UT, Hoffmann SO. Impaired health-related quality of life in inflammatory bowel diseases: psychosocial impact and coping styles in a national German sample. Scand J Gastroenterol. 2001 Apr;36(4):375-82. doi: 10.1080/003655201300051171.
Reference Type
BACKGROUND
Achard S, Salvador R, Whitcher B, Suckling J, Bullmore E. A resilient, low-frequency, small-world human brain functional network with highly connected association cortical hubs. J Neurosci. 2006 Jan 4;26(1):63-72. doi: 10.1523/JNEUROSCI.3874-05.2006.
Reference Type
BACKGROUND
Al-Chaer ED, Lawand NB, Westlund KN, Willis WD. Visceral nociceptive input into the ventral posterolateral nucleus of the thalamus: a new function for the dorsal column pathway. J Neurophysiol. 1996 Oct;76(4):2661-74. doi: 10.1152/jn.1996.76.4.2661.
Reference Type
BACKGROUND
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 Nov-Dec;20(10):1920-4.
Reference Type
BACKGROUND
Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, Stokkers P, Hommes D, Rutgeerts P, Vermeire S, D'Haens G; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology. 2010 Feb;138(2):463-8; quiz e10-1. doi: 10.1053/j.gastro.2009.09.056. Epub 2009 Oct 8.
Reference Type
BACKGROUND
Benarroch EE. The central autonomic network: functional organization, dysfunction, and perspective. Mayo Clin Proc. 1993 Oct;68(10):988-1001. doi: 10.1016/s0025-6196(12)62272-1.
Reference Type
BACKGROUND
Berman SM, Naliboff BD, Suyenobu B, Labus JS, Stains J, Ohning G, Kilpatrick L, Bueller JA, Ruby K, Jarcho J, Mayer EA. Reduced brainstem inhibition during anticipated pelvic visceral pain correlates with enhanced brain response to the visceral stimulus in women with irritable bowel syndrome. J Neurosci. 2008 Jan 9;28(2):349-59. doi: 10.1523/JNEUROSCI.2500-07.2008.
Reference Type
BACKGROUND
Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
Reference Type
BACKGROUND
Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.
Reference Type
BACKGROUND
Biswal BB, Mennes M, Zuo XN, Gohel S, Kelly C, Smith SM, Beckmann CF, Adelstein JS, Buckner RL, Colcombe S, Dogonowski AM, Ernst M, Fair D, Hampson M, Hoptman MJ, Hyde JS, Kiviniemi VJ, Kotter R, Li SJ, Lin CP, Lowe MJ, Mackay C, Madden DJ, Madsen KH, Margulies DS, Mayberg HS, McMahon K, Monk CS, Mostofsky SH, Nagel BJ, Pekar JJ, Peltier SJ, Petersen SE, Riedl V, Rombouts SA, Rypma B, Schlaggar BL, Schmidt S, Seidler RD, Siegle GJ, Sorg C, Teng GJ, Veijola J, Villringer A, Walter M, Wang L, Weng XC, Whitfield-Gabrieli S, Williamson P, Windischberger C, Zang YF, Zhang HY, Castellanos FX, Milham MP. Toward discovery science of human brain function. Proc Natl Acad Sci U S A. 2010 Mar 9;107(10):4734-9. doi: 10.1073/pnas.0911855107. Epub 2010 Feb 22.
Reference Type
BACKGROUND
Bitton A, Dobkin PL, Edwardes MD, Sewitch MJ, Meddings JB, Rawal S, Cohen A, Vermeire S, Dufresne L, Franchimont D, Wild GE. Predicting relapse in Crohn's disease: a biopsychosocial model. Gut. 2008 Oct;57(10):1386-92. doi: 10.1136/gut.2007.134817. Epub 2008 Apr 7.
Reference Type
BACKGROUND
Blankstein U, Chen J, Diamant NE, Davis KD. Altered brain structure in irritable bowel syndrome: potential contributions of pre-existing and disease-driven factors. Gastroenterology. 2010 May;138(5):1783-9. doi: 10.1053/j.gastro.2009.12.043. Epub 2010 Jan 4.
Reference Type
BACKGROUND
Bonaz B, Plourde V, Tache Y. Abdominal surgery induces Fos immunoreactivity in the rat brain. J Comp Neurol. 1994 Nov 8;349(2):212-22. doi: 10.1002/cne.903490205.
Reference Type
BACKGROUND
Bonaz B, Tache Y. Induction of Fos immunoreactivity in the rat brain after cold-restraint induced gastric lesions and fecal excretion. Brain Res. 1994 Jul 25;652(1):56-64. doi: 10.1016/0006-8993(94)90316-6.
Reference Type
BACKGROUND
Bonaz B, Tache Y. Water-avoidance stress-induced c-fos expression in the rat brain and stimulation of fecal output: role of corticotropin-releasing factor. Brain Res. 1994 Mar 28;641(1):21-8. doi: 10.1016/0006-8993(94)91810-4.
Reference Type
BACKGROUND
Bonaz B, Riviere PJ, Sinniger V, Pascaud X, Junien JL, Fournet J, Feuerstein C. Fedotozine, a kappa-opioid agonist, prevents spinal and supra-spinal Fos expression induced by a noxious visceral stimulus in the rat. Neurogastroenterol Motil. 2000 Apr;12(2):135-47. doi: 10.1046/j.1365-2982.2000.00188.x.
Reference Type
BACKGROUND
Bonaz B, Baciu M, Papillon E, Bost R, Gueddah N, Le Bas JF, Fournet J, Segebarth C. Central processing of rectal pain in patients with irritable bowel syndrome: an fMRI study. Am J Gastroenterol. 2002 Mar;97(3):654-61. doi: 10.1111/j.1572-0241.2002.05545.x.
Reference Type
BACKGROUND
Bonaz B, Sabate JM. [Brain-gut axis dysfunction]. Gastroenterol Clin Biol. 2009 Feb;33 Suppl 1:S48-58. doi: 10.1016/S0399-8320(09)71525-8. French.
Reference Type
BACKGROUND
Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.
Reference Type
BACKGROUND
Bouin M, Plourde V, Boivin M, Riberdy M, Lupien F, Laganiere M, Verrier P, Poitras P. Rectal distention testing in patients with irritable bowel syndrome: sensitivity, specificity, and predictive values of pain sensory thresholds. Gastroenterology. 2002 Jun;122(7):1771-7. doi: 10.1053/gast.2002.33601.
Reference Type
BACKGROUND
Boureau F, Luu M, Doubrere JF, Gay C. [Construction of a questionnaire for the self-evaluation of pain using a list of qualifiers. Comparison with Melzack's McGill Pain Questionnaire]. Therapie. 1984 Mar-Apr;39(2):119-29. No abstract available. French.
Reference Type
BACKGROUND
Bouvard, M., Cottreaux, J. Protocoles et échelles d'évaluation en psychiatrie et en psychologie. 4ème Ed, 2005 Masson.
Reference Type
BACKGROUND
Collins SM. Stress and the Gastrointestinal Tract IV. Modulation of intestinal inflammation by stress: basic mechanisms and clinical relevance. Am J Physiol Gastrointest Liver Physiol. 2001 Mar;280(3):G315-8. doi: 10.1152/ajpgi.2001.280.3.G315.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Dammen T, Friis S, Ekeberg O. The Illness Attitude Scales in chest pain patients: a study of psychometric properties. J Psychosom Res. 1999 Apr;46(4):335-42. doi: 10.1016/s0022-3999(98)00127-5.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Fairhurst M, Wiech K, Dunckley P, Tracey I. Anticipatory brainstem activity predicts neural processing of pain in humans. Pain. 2007 Mar;128(1-2):101-10. doi: 10.1016/j.pain.2006.09.001. Epub 2006 Oct 27.
Reference Type
BACKGROUND
Faure C, Giguere L. Functional gastrointestinal disorders and visceral hypersensitivity in children and adolescents suffering from Crohn's disease. Inflamm Bowel Dis. 2008 Nov;14(11):1569-74. doi: 10.1002/ibd.20506.
Reference Type
BACKGROUND
Freeston, M. H., Rheaume, J., Letarte, H., Dugas, M. J., & Ladouceur, R. Why do people worry? Personality and Individual Differences, 1994, 17, 791-802.
Reference Type
BACKGROUND
Geboes K, Collins S. Structural abnormalities of the nervous system in Crohn's disease and ulcerative colitis. Neurogastroenterol Motil. 1998 Jun;10(3):189-202. doi: 10.1046/j.1365-2982.1998.00102.x. No abstract available.
Reference Type
BACKGROUND
Gillanders S, Wild M, Deighan C, Gillanders D. Emotion regulation, affect, psychosocial functioning, and well-being in hemodialysis patients. Am J Kidney Dis. 2008 Apr;51(4):651-62. doi: 10.1053/j.ajkd.2007.12.023.
Reference Type
BACKGROUND
Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009.529. Epub 2009 Sep 15.
Reference Type
BACKGROUND
Guthrie E, Jackson J, Shaffer J, Thompson D, Tomenson B, Creed F. Psychological disorder and severity of inflammatory bowel disease predict health-related quality of life in ulcerative colitis and Crohn's disease. Am J Gastroenterol. 2002 Aug;97(8):1994-9. doi: 10.1111/j.1572-0241.2002.05842.x.
Reference Type
BACKGROUND
Hagmann P, Jonasson L, Maeder P, Thiran JP, Wedeen VJ, Meuli R. Understanding diffusion MR imaging techniques: from scalar diffusion-weighted imaging to diffusion tensor imaging and beyond. Radiographics. 2006 Oct;26 Suppl 1:S205-23. doi: 10.1148/rg.26si065510.
Reference Type
BACKGROUND
Isaacs KL. How rapidly should remission be achieved? Dig Dis. 2010;28(3):548-55. doi: 10.1159/000320415. Epub 2010 Sep 30.
Reference Type
BACKGROUND
Kiebles JL, Doerfler B, Keefer L. Preliminary evidence supporting a framework of psychological adjustment to inflammatory bowel disease. Inflamm Bowel Dis. 2010 Oct;16(10):1685-95. doi: 10.1002/ibd.21215.
Reference Type
BACKGROUND
Labus JS, Mayer EA, Chang L, Bolus R, Naliboff BD. The central role of gastrointestinal-specific anxiety in irritable bowel syndrome: further validation of the visceral sensitivity index. Psychosom Med. 2007 Jan;69(1):89-98. doi: 10.1097/PSY.0b013e31802e2f24.
Reference Type
BACKGROUND
Lembo T, Munakata J, Mertz H, Niazi N, Kodner A, Nikas V, Mayer EA. Evidence for the hypersensitivity of lumbar splanchnic afferents in irritable bowel syndrome. Gastroenterology. 1994 Dec;107(6):1686-96. doi: 10.1016/0016-5085(94)90809-5.
Reference Type
BACKGROUND
Li J, Norgard B, Precht DH, Olsen J. Psychological stress and inflammatory bowel disease: a follow-up study in parents who lost a child in Denmark. Am J Gastroenterol. 2004 Jun;99(6):1129-33. doi: 10.1111/j.1572-0241.2004.04155.x.
Reference Type
BACKGROUND
Lix LM, Graff LA, Walker JR, Clara I, Rawsthorne P, Rogala L, Miller N, Ediger J, Pretorius T, Bernstein CN. Longitudinal study of quality of life and psychological functioning for active, fluctuating, and inactive disease patterns in inflammatory bowel disease. Inflamm Bowel Dis. 2008 Nov;14(11):1575-84. doi: 10.1002/ibd.20511.
Reference Type
BACKGROUND
Lomax AE, Fernandez E, Sharkey KA. Plasticity of the enteric nervous system during intestinal inflammation. Neurogastroenterol Motil. 2005 Feb;17(1):4-15. doi: 10.1111/j.1365-2982.2004.00607.x.
Reference Type
BACKGROUND
Mansfield P. Real-time echo-planar imaging by NMR. Br Med Bull. 1984 Apr;40(2):187-90. doi: 10.1093/oxfordjournals.bmb.a071970. No abstract available.
Reference Type
BACKGROUND
McCracken LM, Zayfert C, Gross RT. The Pain Anxiety Symptoms Scale: development and validation of a scale to measure fear of pain. Pain. 1992 Jul;50(1):67-73. doi: 10.1016/0304-3959(92)90113-P.
Reference Type
BACKGROUND
McNeil DW, Rainwater AJ 3rd. Development of the Fear of Pain Questionnaire--III. J Behav Med. 1998 Aug;21(4):389-410. doi: 10.1023/a:1018782831217.
Reference Type
BACKGROUND
Meregnani J, Clarencon D, Vivier M, Peinnequin A, Mouret C, Sinniger V, Picq C, Job A, Canini F, Jacquier-Sarlin M, Bonaz B. Anti-inflammatory effect of vagus nerve stimulation in a rat model of inflammatory bowel disease. Auton Neurosci. 2011 Feb 24;160(1-2):82-9. doi: 10.1016/j.autneu.2010.10.007. Epub 2010 Nov 11.
Reference Type
BACKGROUND
Mertz H, Naliboff B, Munakata J, Niazi N, Mayer EA. Altered rectal perception is a biological marker of patients with irritable bowel syndrome. Gastroenterology. 1995 Jul;109(1):40-52. doi: 10.1016/0016-5085(95)90267-8.
Reference Type
BACKGROUND
Minderhoud IM, Oldenburg B, Wismeijer JA, van Berge Henegouwen GP, Smout AJ. IBS-like symptoms in patients with inflammatory bowel disease in remission; relationships with quality of life and coping behavior. Dig Dis Sci. 2004 Mar;49(3):469-74. doi: 10.1023/b:ddas.0000020506.84248.f9.
Reference Type
BACKGROUND
Ogawa S, Lee TM, Nayak AS, Glynn P. Oxygenation-sensitive contrast in magnetic resonance image of rodent brain at high magnetic fields. Magn Reson Med. 1990 Apr;14(1):68-78. doi: 10.1002/mrm.1910140108.
Reference Type
BACKGROUND
Ohlsson B, Sundkvist G, Lindgren S. Subclinical sympathetic neuropathy appears early in the course of Crohn's disease. BMC Gastroenterol. 2007 Aug 14;7:33. doi: 10.1186/1471-230X-7-33.
Reference Type
BACKGROUND
Pavlov VA, Wang H, Czura CJ, Friedman SG, Tracey KJ. The cholinergic anti-inflammatory pathway: a missing link in neuroimmunomodulation. Mol Med. 2003 May-Aug;9(5-8):125-34.
Reference Type
BACKGROUND
Piche T, Ducrotte P, Sabate JM, Coffin B, Zerbib F, Dapoigny M, Hua M, Marine-Barjoan E, Dainese R, Hebuterne X. Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome. Neurogastroenterol Motil. 2010 Jun;22(6):626-e174. doi: 10.1111/j.1365-2982.2010.01502.x. Epub 2010 Apr 19.
Reference Type
BACKGROUND
Ploghaus A, Tracey I, Gati JS, Clare S, Menon RS, Matthews PM, Rawlins JN. Dissociating pain from its anticipation in the human brain. Science. 1999 Jun 18;284(5422):1979-81. doi: 10.1126/science.284.5422.1979.
Reference Type
BACKGROUND
Ploghaus A, Becerra L, Borras C, Borsook D. Neural circuitry underlying pain modulation: expectation, hypnosis, placebo. Trends Cogn Sci. 2003 May;7(5):197-200. doi: 10.1016/s1364-6613(03)00061-5.
Reference Type
BACKGROUND
Porro CA, Baraldi P, Pagnoni G, Serafini M, Facchin P, Maieron M, Nichelli P. Does anticipation of pain affect cortical nociceptive systems? J Neurosci. 2002 Apr 15;22(8):3206-14. doi: 10.1523/JNEUROSCI.22-08-03206.2002.
Reference Type
BACKGROUND
Posserud I, Syrous A, Lindstrom L, Tack J, Abrahamsson H, Simren M. Altered rectal perception in irritable bowel syndrome is associated with symptom severity. Gastroenterology. 2007 Oct;133(4):1113-23. doi: 10.1053/j.gastro.2007.07.024. Epub 2007 Jul 25.
Reference Type
BACKGROUND
Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas 1977 ; 3 : 385-401.
Reference Type
BACKGROUND
Reber SO, Obermeier F, Straub RH, Falk W, Neumann ID. Chronic intermittent psychosocial stress (social defeat/overcrowding) in mice increases the severity of an acute DSS-induced colitis and impairs regeneration. Endocrinology. 2006 Oct;147(10):4968-76. doi: 10.1210/en.2006-0347. Epub 2006 Jun 22.
Reference Type
BACKGROUND
Ritchie J. Pain from distension of the pelvic colon by inflating a balloon in the irritable colon syndrome. Gut. 1973 Feb;14(2):125-32. doi: 10.1136/gut.14.2.125.
Reference Type
BACKGROUND
Saper CB. The central autonomic nervous system: conscious visceral perception and autonomic pattern generation. Annu Rev Neurosci. 2002;25:433-69. doi: 10.1146/annurev.neuro.25.032502.111311. Epub 2002 Mar 25.
Reference Type
BACKGROUND
Schnitzler F, Fidder H, Ferrante M, Noman M, Arijs I, Van Assche G, Hoffman I, Van Steen K, Vermeire S, Rutgeerts P. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflamm Bowel Dis. 2009 Sep;15(9):1295-301. doi: 10.1002/ibd.20927.
Reference Type
BACKGROUND
Schoepfer AM, Trummler M, Seeholzer P, Seibold-Schmid B, Seibold F. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis. 2008 Jan;14(1):32-9. doi: 10.1002/ibd.20275.
Reference Type
BACKGROUND
Schweinhardt P, Bushnell MC. Pain imaging in health and disease--how far have we come? J Clin Invest. 2010 Nov;120(11):3788-97. doi: 10.1172/JCI43498. Epub 2010 Nov 1.
Reference Type
BACKGROUND
Seminowicz DA, Labus JS, Bueller JA, Tillisch K, Naliboff BD, Bushnell MC, Mayer EA. Regional gray matter density changes in brains of patients with irritable bowel syndrome. Gastroenterology. 2010 Jul;139(1):48-57.e2. doi: 10.1053/j.gastro.2010.03.049. Epub 2010 Mar 27.
Reference Type
BACKGROUND
Seminowicz DA, Mikulis DJ, Davis KD. Cognitive modulation of pain-related brain responses depends on behavioral strategy. Pain. 2004 Nov;112(1-2):48-58. doi: 10.1016/j.pain.2004.07.027.
Reference Type
BACKGROUND
Simren M, Axelsson J, Gillberg R, Abrahamsson H, Svedlund J, Bjornsson ES. Quality of life in inflammatory bowel disease in remission: the impact of IBS-like symptoms and associated psychological factors. Am J Gastroenterol. 2002 Feb;97(2):389-96. doi: 10.1111/j.1572-0241.2002.05475.x.
Reference Type
BACKGROUND
Sipponen T, Karkkainen P, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Farkkila M. Correlation of faecal calprotectin and lactoferrin with an endoscopic score for Crohn's disease and histological findings. Aliment Pharmacol Ther. 2008 Nov 15;28(10):1221-9. doi: 10.1111/j.1365-2036.2008.03835.x. Epub 2008 Aug 26.
Reference Type
BACKGROUND
Song GH, Venkatraman V, Ho KY, Chee MW, Yeoh KG, Wilder-Smith CH. Cortical effects of anticipation and endogenous modulation of visceral pain assessed by functional brain MRI in irritable bowel syndrome patients and healthy controls. Pain. 2006 Dec 15;126(1-3):79-90. doi: 10.1016/j.pain.2006.06.017. Epub 2006 Jul 18.
Reference Type
BACKGROUND
Spaziani R, Bayati A, Redmond K, Bajaj H, Mazzadi S, Bienenstock J, Collins SM, Kamath MV. Vagal dysfunction in irritable bowel syndrome assessed by rectal distension and baroreceptor sensitivity. Neurogastroenterol Motil. 2008 Apr;20(4):336-42. doi: 10.1111/j.1365-2982.2007.01042.x. Epub 2007 Dec 19.
Reference Type
BACKGROUND
Spetalen S, Sandvik L, Blomhoff S, Jacobsen MB. Autonomic function at rest and in response to emotional and rectal stimuli in women with irritable bowel syndrome. Dig Dis Sci. 2008 Jun;53(6):1652-9. doi: 10.1007/s10620-007-0066-0.
Reference Type
BACKGROUND
Spielberger, C.D., Gorsuch, R., Lushene, R. 1983. The State-Trait Personality Inventory (STAI, Form Y), Palo Alto, CA, Consulting Psychologists Press.
Reference Type
BACKGROUND
Sullivan, M.J.L., Bishop, S. and Pivik, J. The Pain Catastrophizing Scale: Development and validation. Psychol. Assess. 1995, 7: 524-532.
Reference Type
BACKGROUND
Summerton CB, Longlands MG, Wiener K, Shreeve DR. Faecal calprotectin: a marker of inflammation throughout the intestinal tract. Eur J Gastroenterol Hepatol. 2002 Aug;14(8):841-5. doi: 10.1097/00042737-200208000-00005.
Reference Type
BACKGROUND
Talairach J and Tournoux P,
Reference Type
BACKGROUND
Tang LY, Nabalamba A, Graff LA, Bernstein CN. A comparison of self-perceived health status in inflammatory bowel disease and irritable bowel syndrome patients from a Canadian national population survey. Can J Gastroenterol. 2008 May;22(5):475-83. doi: 10.1155/2008/109218.
Reference Type
BACKGROUND
Taylor CT, Keely SJ. The autonomic nervous system and inflammatory bowel disease. Auton Neurosci. 2007 Apr 30;133(1):104-14. doi: 10.1016/j.autneu.2006.11.005. Epub 2007 Jan 17.
Reference Type
BACKGROUND
Thompson SC. Will it hurt less if i can control it? A complex answer to a simple question. Psychol Bull. 1981 Jul;90(1):89-101. No abstract available.
Reference Type
BACKGROUND
Tibble J, Teahon K, Thjodleifsson B, Roseth A, Sigthorsson G, Bridger S, Foster R, Sherwood R, Fagerhol M, Bjarnason I. A simple method for assessing intestinal inflammation in Crohn's disease. Gut. 2000 Oct;47(4):506-13. doi: 10.1136/gut.47.4.506.
Reference Type
BACKGROUND
Tibble JA, Sigthorsson G, Bridger S, Fagerhol MK, Bjarnason I. Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatory bowel disease. Gastroenterology. 2000 Jul;119(1):15-22. doi: 10.1053/gast.2000.8523.
Reference Type
BACKGROUND
van Orshoven NP, Andriesse GI, van Schelven LJ, Smout AJ, Akkermans LM, Oey PL. Subtle involvement of the parasympathetic nervous system in patients with irritable bowel syndrome. Clin Auton Res. 2006 Feb;16(1):33-9. doi: 10.1007/s10286-006-0307-x.
Reference Type
BACKGROUND
Van Oudenhove L, Vandenberghe J, Dupont P, Geeraerts B, Vos R, Dirix S, Bormans G, Vanderghinste D, Van Laere K, Demyttenaere K, Fischler B, Tack J. Abnormal regional brain activity during rest and (anticipated) gastric distension in functional dyspepsia and the role of anxiety: a H(2)(15)O-PET study. Am J Gastroenterol. 2010 Apr;105(4):913-24. doi: 10.1038/ajg.2010.39. Epub 2010 Feb 16.
Reference Type
BACKGROUND
Verma-Gandhu M, Bercik P, Motomura Y, Verdu EF, Khan WI, Blennerhassett PA, Wang L, El-Sharkawy RT, Collins SM. CD4+ T-cell modulation of visceral nociception in mice. Gastroenterology. 2006 May;130(6):1721-8. doi: 10.1053/j.gastro.2006.01.045.
Reference Type
BACKGROUND
Wagner M, Peterson CG, Ridefelt P, Sangfelt P, Carlson M. Fecal markers of inflammation used as surrogate markers for treatment outcome in relapsing inflammatory bowel disease. World J Gastroenterol. 2008 Sep 28;14(36):5584-9; discussion 5588. doi: 10.3748/wjg.14.5584.
Reference Type
BACKGROUND
Walach H., Buttenmuller, V., Kleinknecht N., Schmidt S. Measuring mindfulness - the Freiburg Mindfulness Inventory (FMI). Personnality and Individual Differences, 2006, 40:1543-1555.
Reference Type
BACKGROUND
Weisenberg M, Schwarzwald J, Tepper I. The influence of warning signal timing and cognitive preparation on the aversiveness of cold-pressor pain. Pain. 1996 Feb;64(2):379-385. doi: 10.1016/0304-3959(95)00105-0.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC11.220
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
NCT03623932
UNKNOWN
NA
Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD
NCT06214299
NOT_YET_RECRUITING
Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
NCT05733845
RECRUITING
NA
Can CT Enteroclysis Predict the Outcome of Crohn's Disease
NCT00572780
COMPLETED
Psychology of Crohn's Disease
NCT01573078
COMPLETED
Pain in Patients With Crohn Disease (PAINCD)
NCT04488146
UNKNOWN
Brain-Gut Interactions in Crohn's Disease
NCT02108938
COMPLETED
Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study
NCT02867540
UNKNOWN
NA
Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
NCT07168499
RECRUITING
NA
Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients
NCT05713409
UNKNOWN
STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
NCT04973423
RECRUITING
NA
Vagus Nerve Stimulation a New Approach in the Treatment of Crohn's Disease
NCT01569503
TERMINATED
PHASE3
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
NCT02549976
COMPLETED
NA
Magnetic Resonance Imaging of Motility in Crohn's 2
NCT03052465
COMPLETED
NA
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
NCT05835973
RECRUITING
NA
GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease
NCT02245594
UNKNOWN
Postoperative REcurrence and DynamICs of T Cell Subsets in Crohn's Disease
NCT02770495
COMPLETED
PHASE3
A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease
NCT03435016
COMPLETED
NA
Stress in Crohn's Disease
NCT04809194
COMPLETED
Cognition and Emotion in the SII and IBD
NCT01095042
COMPLETED
NA
Anorectal Function in Perianal Crohn's Disease
NCT03819257
COMPLETED
Psychobiology in Inflammatory Bowel Disease(IBD)
NCT00248742
COMPLETED
NA
Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study
NCT07093294
RECRUITING
The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease
NCT02578576
UNKNOWN