Clinical trial NCT01106339: Immune Patterns in Pain Patients DSM-IV
Official title: Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Somatoform Disorders
Fibromyalgia
Myofascial Pain Syndrome, Diffuse
Depression
Chronic Fatigue Syndrome
Keywords: humans
patients
somatoform disorders
fibromyalgia
myofascial pain syndrome diffuse
depression
chronic fatigue syndrome
inflammation
inflammatory response
biomarkers
cytokines
cell surface markers
functional polymorphisms
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: University Hospital Ulm
First posted: 2010-04-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic pain patients with a somatoform disorder due to DSM-IV

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.

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

Primary outcomes:
measure: Pattern of inflammatory biomarkers
timeFrame: 1 year
Secondary outcomes:
measure: Pattern of cell surface markers
timeFrame: 1 year
measure: Functional polymorphisms
timeFrame: 1 year
measure: Psychometric tests
timeFrame: 1 year
measure: Demographic tests
timeFrame: 1 year
measure: Severity of pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Clinic of Anesthesiology, Dept. of Pain
Study officials:
affiliation: Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
name: Peter Steffen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.