ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00222209
Recruitment Status : Unknown
Verified September 2005 by Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : August 3, 2006
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Universitätsmedizin Mannheim

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Irritable Bowel Syndrome Behavioral: Experimental heat pain model Not Applicable

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).


Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes
Study Start Date : September 2005
Study Completion Date : November 2007
Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00222209     History of Changes
Other Study ID Numbers: DFG HO 904/11-3,4
First Posted: September 22, 2005    Key Record Dates
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