Immune Patterns in Pain Patients DSM-IV (IPPPDIV)

This study has been completed.
Sponsor:
Collaborator:
University Hospital Ulm
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm
ClinicalTrials.gov Identifier:
NCT01106339
First received: April 15, 2010
Last updated: April 3, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Pattern of inflammatory biomarkers [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pattern of cell surface markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Functional polymorphisms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Psychometric tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Demographic tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Severity of pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 15, 2010
Last Updated: April 3, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by 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:
Depression
Depressive Disorder
Fatigue
Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes
Somatoform Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014