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

Sponsor

Universitätsmedizin Mannheim (Other)

Overall Status

Unknown status

CT.gov ID

NCT00222209

Collaborator

German Research Foundation (Other)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Sep 1, 2005

Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

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

Locations

	Site	City	State	Country	Postal Code
1	University of Mannheim - Otto-Selz-Institute	Mannheim		Germany	D-68131

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