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

NCT00222209 | Unknown

• 1 other identifier: DFG HO 904/11-3,4
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Irritable Bowel Syndrome

Keywords

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

Interventions

Experimental heat pain model BEHAVIORAL

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Abnormal quantitative sensory testing
• Psychiatric or neurological anamnesis, except fear and depression
• Acute major depression
• Substance abuse

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead
• German Research Foundation: collaborator

Study Sites (1)

University of Mannheim - Otto-Selz-Institute

Mannheim, D-68131, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 15836965 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.

  PMID: 10353491 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Ulrike Kiessling, Dr. phil.

CONTACT

+49 621 181 3406; hornberger@osi.uni-mannheim.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Study Completion: November 1, 2007
• Last Updated: August 3, 2006

Record last verified: 2005-09

Locations

DE (1)