Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2005 by Universitätsmedizin Mannheim.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00222209

First Posted: September 22, 2005

Last Update Posted: August 3, 2006

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

German Research Foundation

Information provided by:

Universitätsmedizin Mannheim

Purpose

The project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming chronic, which is augmented by fear and by avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are further promoting factors in chronic pain development.

Condition	Intervention
Fibromyalgia Irritable Bowel Syndrome	Behavioral: Experimental heat pain model


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Diagnostic
Official Title:	Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes

Further study details as provided by Universitätsmedizin Mannheim:


Estimated Enrollment:	64
Study Start Date:	September 2005
Estimated Study Completion Date:	November 2007

Detailed Description:

Study 1: Implicit operant learning of sensitization and habituation in an experimental heat pain model will be investigated and compared in healthy controls, chronic pain patients with fibromyalgia, with and w/o visceral pain.

Study 2: Functional imaging of implicit operant learning of sensitization and habituation in an experimental heat pain model (same subgroups as in study 1).

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Fibromyalgia according to American College of Rheumatology (ACR) criteria
Visceral hypersensitivity according to ROME criteria
Chronic pain according to International Association for the Study of Pain (IASP) criteria

Exclusion Criteria:

Abnormal quantitative sensory testing
Psychiatric or neurological anamnesis, except fear and depression
Acute major depression
Substance abuse

Contacts and Locations

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): NCT00222209

Contacts


Contact: Ulrike Kiessling, Dr. phil.	+49 621 181 3406	hornberger@osi.uni-mannheim.de

Locations


Germany
University of Mannheim - Otto-Selz-Institute	Recruiting
Mannheim, Germany, D-68131
Contact: Dieter Kleinboehl, Dr. phil. +49 621 181 2111 kleinboehl@osi.uni-mannheim.de

Sponsors and Collaborators

Universitätsmedizin Mannheim

German Research Foundation

Investigators


Study Director:	Rupert Hoelzl, Prof. Dr. phil.	University of Mannheim
Study Director:	Hans-Joachim Bender, Prof. Dr. med. rer. nat.	Universitätsmedizin Mannheim
Study Director:	Lothar-Rudi Schad, Prof. Dr. rer. nat.	German Cancer Research Centre Heidelberg

More Information

Publications:

Hölzl R, Kleinböhl D, Huse E. Implicit operant learning of pain sensitization. Pain. 2005 May;115(1-2):12-20.

Kleinböhl D, Hölzl R, Möltner A, Rommel C, Weber C, Osswald PM. Psychophysical measures of sensitization to tonic heat discriminate chronic pain patients. Pain. 1999 May;81(1-2):35-43.


ClinicalTrials.gov Identifier:	NCT00222209 History of Changes
Other Study ID Numbers:	DFG HO 904/11-3,4
First Submitted:	September 13, 2005
First Posted:	September 22, 2005
Last Update Posted:	August 3, 2006
Last Verified:	September 2005

Keywords provided by Universitätsmedizin Mannheim:


Experimental study chronic pain operant learning comorbidity	stress Fibromyalgia w visceral hypersensitivity Fibromyalgia w/o visceral hypersensitivity

Additional relevant MeSH terms:


Syndrome Fibromyalgia Myofascial Pain Syndromes Irritable Bowel Syndrome Disease Pathologic Processes Muscular Diseases Musculoskeletal Diseases	Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases

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