Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia Irritable Bowel Syndrome | Behavioral: Experimental heat pain model | Not Applicable |
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 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 |

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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

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