Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain
Recruitment status was Recruiting
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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 Blind Primary Purpose: Diagnostic |
| Official Title: | Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes |
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | November 2007 |
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| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications:
| ClinicalTrials.gov 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 |
| Health Authority: | Germany: Deutsche Forschungsgemeinschaft (DFG) |
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:
|
Colonic Diseases, Functional Fibromyalgia Irritable Bowel Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015