Immune Patterns in Pain Patients DSM-IV

NCT ID: NCT01106339

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-04-30

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Patients with somatoform disorders due to DSM-IV

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Ulm

OTHER

Sponsor Role: collaborator

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Manfred Weiss

Professor, MD, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Steffen, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

Locations

Clinic of Anesthesiology, Dept. of Pain

Ulm, , Germany

Countries

Germany

References

Schneider EM, Ma X, Stratz T, Muller W, Lorenz I, Seeling WD. Immunomodulatory function of the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:34-40.

Reference Type: BACKGROUND

PMID: 15515411 (View on PubMed)

Other Identifiers

Anae_Pain_Ulm_DSM-IV

Identifier Type: -

Identifier Source: org_study_id