IPPPDIV: Immune Patterns in Pain Patients DSM-IV

Sponsor

University of Ulm (Other)

Overall Status

Completed

CT.gov ID

NCT01106339

Collaborator

University Hospital Ulm (Other)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Somatoform Disorders Fibromyalgia Myofascial Pain Syndrome, Diffuse Depression Chronic Fatigue Syndrome

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.

Study Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
A Patients with somatoform disorders due to DSM-IV

Outcome Measures

Primary Outcome Measures

Pattern of inflammatory biomarkers [1 year]

Secondary Outcome Measures

Pattern of cell surface markers [1 year]
Functional polymorphisms [1 year]
Psychometric tests [1 year]
Demographic tests [1 year]
Severity of pain [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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