MedDataX Logo

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

NCT ID: NCT00222209

Last Updated: 2006-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia Irritable Bowel Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental heat pain model

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Research Foundation

OTHER

Sponsor Role collaborator

Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rupert Hoelzl, Prof. Dr. phil.

Role: STUDY_DIRECTOR

University of Mannheim

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

Role: STUDY_DIRECTOR

Universitätsmedizin Mannheim

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

Role: STUDY_DIRECTOR

German Cancer Research Centre Heidelberg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Mannheim - Otto-Selz-Institute

Mannheim, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ulrike Kiessling, Dr. phil.

Role: CONTACT

Phone: +49 621 181 3406

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dieter Kleinboehl, Dr. phil.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15836965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10353491 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DFG HO 904/11-3,4

Identifier Type: -

Identifier Source: org_study_id