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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
German Research Foundation
Information provided by:
Universitätsmedizin Mannheim Identifier:
First received: September 13, 2005
Last updated: August 2, 2006
Last verified: September 2005
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
Irritable Bowel Syndrome
Behavioral: Experimental heat pain model

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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).


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

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
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Please refer to this study by its identifier: NCT00222209

Contact: Ulrike Kiessling, Dr. phil. +49 621 181 3406

University of Mannheim - Otto-Selz-Institute Recruiting
Mannheim, Germany, D-68131
Contact: Dieter Kleinboehl, Dr. phil.    +49 621 181 2111   
Sponsors and Collaborators
Universitätsmedizin Mannheim
German Research Foundation
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: Identifier: NCT00222209     History of Changes
Other Study ID Numbers: DFG HO 904/11-3,4
Study First Received: September 13, 2005
Last Updated: August 2, 2006

Keywords provided by Universitätsmedizin Mannheim:
Experimental study
chronic pain
operant learning
Fibromyalgia w visceral hypersensitivity
Fibromyalgia w/o visceral hypersensitivity

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Irritable Bowel Syndrome
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 processed this record on May 25, 2017