Immune Patterns in Pain Patients DSM-IV

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

Detailed Description
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients with somatoform disorders due to DSM-IV | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of inflammatory biomarkers |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of cell surface markers |  | 1 year | 
| Functional polymorphisms |  | 1 year | 
| Psychometric tests |  | 1 year | 
| Demographic tests |  | 1 year | 
| Severity of pain |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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humans, patients, somatoform disorders, fibromyalgia, myofascial pain syndrome diffuse, depression, chronic fatigue syndrome, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, functional polymorphisms