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

Fibromyalgia Clinical Trial

Official title:

Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00222209
• Other study ID #: DFG HO 904/11-3,4
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 2, 2006
• Start date: September 2005
• Est. completion date: November 2007

Study information

• Verified date: September 2005
• Source: Universitätsmedizin Mannheim
• Contact: Ulrike Kiessling, Dr. phil.
• Phone: +49 621 181 3406
• Email: hornberger[@]osi.uni-mannheim.de
• Is FDA regulated: No
• Health authority: Germany: Deutsche Forschungsgemeinschaft (DFG)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fibromyalgia
• Irritable Bowel Syndrome
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Experimental heat pain model

Locations

Country	Name	City	State
Germany	University of Mannheim - Otto-Selz-Institute	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Hölzl R, Kleinböhl D, Huse E. Implicit operant learning of pain sensitization. Pain. 2005 May;115(1-2):12-20. — View Citation

Kleinböhl D, Hölzl R, Möltner 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. — View Citation