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Immune Patterns in Pain Patients DSM-IV

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01106339
Acronym
IPPPDIV
Enrollment
52
Registered
2010-04-19
Start date
2007-08-31
Completion date
2013-04-30
Last updated
2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

humans, patients, somatoform disorders, fibromyalgia, myofascial pain syndrome diffuse, depression, chronic fatigue syndrome, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, functional polymorphisms

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.

Interventions

None listed

Sponsors

University Hospital Ulm
CollaboratorOTHER
University of Ulm
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
Pattern of inflammatory biomarkers1 year

Secondary

MeasureTime frame
Pattern of cell surface markers1 year
Functional polymorphisms1 year
Psychometric tests1 year
Demographic tests1 year
Severity of pain1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026