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

Primary Purpose

Fibromyalgia, Irritable Bowel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Experimental heat pain model

About this trial

This is an interventional diagnostic trial for Fibromyalgia focused on measuring Experimental study, chronic pain, operant learning, comorbidity, stress, Fibromyalgia w visceral hypersensitivity, Fibromyalgia w/o visceral hypersensitivity

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Mannheim - Otto-Selz-InstituteRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00222209

First Posted

September 13, 2005

Last Updated

August 2, 2006

Sponsor

Universitätsmedizin Mannheim

Collaborators

German Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00222209

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Universitätsmedizin Mannheim

Collaborators

German Research Foundation

4. Oversight

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Irritable Bowel Syndrome

Keywords

Experimental study, chronic pain, operant learning, comorbidity, stress, Fibromyalgia w visceral hypersensitivity, Fibromyalgia w/o visceral hypersensitivity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

64 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Experimental heat pain model

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ulrike Kiessling, Dr. phil.

Phone

+49 621 181 3406

hornberger@osi.uni-mannheim.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rupert Hoelzl, Prof. Dr. phil.

Organizational Affiliation

University of Mannheim

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hans-Joachim Bender, Prof. Dr. med. rer. nat.

Organizational Affiliation

Universitätsmedizin Mannheim

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lothar-Rudi Schad, Prof. Dr. rer. nat.

Organizational Affiliation

German Cancer Research Centre Heidelberg

Official's Role

Study Director

Facility Information:

Facility Name

University of Mannheim - Otto-Selz-Institute

City

Mannheim

ZIP/Postal Code

D-68131

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dieter Kleinboehl, Dr. phil.

Phone

+49 621 181 2111

kleinboehl@osi.uni-mannheim.de

12. IPD Sharing Statement

Citations:

PubMed Identifier

15836965

Citation

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.

Results Reference

background

PubMed Identifier

10353491

Citation

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.

Results Reference

background

Learn more about this trial

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

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