Clinical Study on Implicit Learning, Comorbidity and Stre... | NCT00222209

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

NCT00222209

Sponsor

Universitätsmedizin Mannheim

Status

Unknown status

Last Update Posted

Aug 3, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Fibromyalgia
Irritable Bowel Syndrome

Interventions

Experimental heat pain model

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Nov 2007

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2006

Last Update Posted Date

Aug 3, 2006Estimated

Name	Class
German Research Foundation	OTHER

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Experimental heat pain model	Behavioral

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ulrike Kiessling, Dr. phil.	Contact	+49 621 181 3406		hornberger@osi.uni-mannheim.de

Overall Officials

Name	Affiliation	Role
Rupert Hoelzl, Prof. Dr. phil.	University of Mannheim	Study Director
Hans-Joachim Bender, Prof. Dr. med. rer. nat.	Universitätsmedizin Mannheim	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mannheim - Otto-Selz-Institute	Recruiting	Mannheim		D-68131	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15836965	Background	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.
10353491	Background	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.

ID	Term
D005356	Fibromyalgia
D043183	Irritable Bowel Syndrome
D059350	Chronic Pain

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases