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临床试验/NCT01106339
NCT01106339已完成不适用

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

University of Ulm1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Pattern of inflammatory biomarkers

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Pattern of inflammatory biomarkers

时间窗: 1 year

次要结局

  • Severity of pain(1 year)
  • Pattern of cell surface markers(1 year)
  • Functional polymorphisms(1 year)
  • Demographic tests(1 year)
  • Psychometric tests(1 year)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfred Weiss

Professor, MD, MBA

University of Ulm

研究点 (1)

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