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Completed

NCT Number: NCT01106339

Immune Patterns in Pain Patients DSM-IV

The purpose of this study is to define subgroups of patients with somatoform disorders due to DSM-IV by immunological, psychological and genetic characterization.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pattern of inflammatory biomarkers

    Time frame: 1 year

Secondary outcomes

  1. Pattern of cell surface markers

    Time frame: 1 year

  2. Functional polymorphisms

    Time frame: 1 year

  3. Psychometric tests

    Time frame: 1 year

  4. Demographic tests

    Time frame: 1 year

  5. Severity of pain

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • University Hospital Ulm

Registry information

Official study title

Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV

Acronym: IPPPDIV

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2010
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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