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Immune Patterns in Pain Patients DSM-IV (IPPPDIV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106339
First Posted: April 19, 2010
Last Update Posted: April 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Ulm
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm
  Purpose
The purpose of this study is to define subgroups of patients with somatoform disorders due to DSM-IV by immunological, psychological and genetic characterization.

Condition
Somatoform Disorders Fibromyalgia Myofascial Pain Syndrome, Diffuse Depression Chronic Fatigue Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV

Further study details as provided by Manfred Weiss, University of Ulm:

Primary Outcome Measures:
  • Pattern of inflammatory biomarkers [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Pattern of cell surface markers [ Time Frame: 1 year ]
  • Functional polymorphisms [ Time Frame: 1 year ]
  • Psychometric tests [ Time Frame: 1 year ]
  • Demographic tests [ Time Frame: 1 year ]
  • Severity of pain [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum, and white cells will be retained.

Enrollment: 52
Study Start Date: August 2007
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Patients with somatoform disorders due to DSM-IV

Detailed Description:
Pain patients are defined as patients with a somatoform disorder due to DSM-IV, if chronic pain lasts for at least 6 months in several anatomical regions. Somatoform disorders (DSM-IV) have the presence of physical symptoms that suggest a general medical condition but that are not fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder. The symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning. The physical symptoms are not under voluntary control. Psychic factors exclusively or in combination with a medical disease factor influence onset, severity, exacerbation or maintenance of symptoms decisively. A subgroup of somatoform disorders, i.e., fibromyalgia, is a common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, headaches, and occasionally depression. There is significant overlap between fibromyalgia and the chronic fatigue syndrome. Fibromyalgia may arise as a primary or secondary disease process. Interleukins IL-1ß, IL-6 und tumor necrosis factor-a have been detected in the skin of these patients. Blockade of the 5HT3 receptor has been reported to alleviate chronic pain in tendopathy, fibromyalgia and autoimmune diseases. However, only a subgroup of patients responds to this therapy. It is supposed that patients with somatoform disorders (DSM-IV) diagnosed according to clinical criteria consist of immunologically heterogenous groups. However, up to now, the immunologic and genetic background of patients with somatoform disorders classified via DSM-IV has not been systematically evaluated. The study concentrates on the psychometric characterization of patients with pain disorder focusing on depression, anxiety, coping behavior, psychic trauma, alexithymia and somatoform symptoms. The present study is performed to define subgroups of patients with somatoform disorders (DSM-IV) by immunological, pyschologic and genetic characterization which may benefit from potential 5HT3 receptor antagonists or anti-inflammatory therapy.
  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
chronic pain patients with a somatoform disorder due to DSM-IV
Criteria

Inclusion Criteria:

  • chronic pain patients with a somatoform disorder due to DSM-IV
  • chronic pain > 6 months in several anatomical regions
  • presence of physical symptoms that suggest a general medical condition
  • the symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning
  • the physical symptoms are not under voluntary control
  • Psychic factors exclusively or in combination with a medical disease factor influence onset, severity, exacerbation or maintenance of symptoms decisively
  • fibromyalgia

Exclusion Criteria:

  • age < 18 years
  • psychosis
  • symptoms fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder
  • pregnancy
  • inclusion in other studies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106339


Locations
Germany
Clinic of Anesthesiology, Dept. of Pain
Ulm, Germany, 89070
Sponsors and Collaborators
University of Ulm
University Hospital Ulm
Investigators
Principal Investigator: Peter Steffen, MD Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
  More Information

Publications:
Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm
ClinicalTrials.gov Identifier: NCT01106339     History of Changes
Other Study ID Numbers: Anae_Pain_Ulm_DSM-IV
First Submitted: April 15, 2010
First Posted: April 19, 2010
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Manfred Weiss, University of Ulm:
humans
patients
somatoform disorders
fibromyalgia
myofascial pain syndrome diffuse
depression
chronic fatigue syndrome
inflammation
inflammatory response
biomarkers
cytokines
cell surface markers
functional polymorphisms

Additional relevant MeSH terms:
Syndrome
Depression
Fatigue
Fibromyalgia
Myofascial Pain Syndromes
Fatigue Syndrome, Chronic
Somatoform Disorders
Disease
Pathologic Processes
Behavioral Symptoms
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases
Mental Disorders