Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain
August 2, 2006 updated by: Universitätsmedizin Mannheim
Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mannheim, Germany, D-68131
- Recruiting
- University of Mannheim - Otto-Selz-Institute
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Contact:
- Dieter Kleinboehl, Dr. phil.
- Phone Number: +49 621 181 2111
- Email: kleinboehl@osi.uni-mannheim.de
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holzl R, Kleinbohl D, Huse E. Implicit operant learning of pain sensitization. Pain. 2005 May;115(1-2):12-20. doi: 10.1016/j.pain.2005.01.026.
- Kleinbohl D, Holzl R, Moltner 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. doi: 10.1016/s0304-3959(98)00266-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion
November 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
August 3, 2006
Last Update Submitted That Met QC Criteria
August 2, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Disease
- Gastrointestinal Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Fibromyalgia
- Myofascial Pain Syndromes
Other Study ID Numbers
- DFG HO 904/11-3,4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.