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临床试验/NCT05328518
NCT05328518招募中不适用

Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
286
试验地点
1
主要终点
To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination.

研究概览

简要总结

Numerous studies reported on comorbidity of fibromyalgia and psychiatric disorders. Approximately 30% of patients with fibromyalgia have major depression at the time of diagnosis; the lifetime prevalence of depression is 74% and that of an anxiety disorder is 60%. In some fibromyalgia patients, mood and cognitive problems are much more prominent than tenderness. From the psychiatric point of view, 49% of PTSD patients and 5% of major depression patients fulfill criteria for diagnosing fibromyalgia.

The association between schizophrenia and fibromyalgia is still unknown.

Study hypothesis Schizophrenia patients, who have an aberrant sensation of pain, have lower prevalence of FM compared to the general population.

Primary objectives

  1. Demonstrate that schizophrenia patients have lower prevalence of FM, compared to the general population.
  2. To compare the self-reported extent and intensity of pain with selected tender points examination.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women above 18 years of age.
  • Patients must meet DSM-5 criteria for a diagnosis of schizophrenia.
  • A stabled mental state.
  • If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms.

排除标准

  • Mental co-morbidity.
  • Diagnosis of myofascial pain syndrome or chronic fatigue syndrome.
  • Alcohol or drug use.
  • Usage of any pain reliever medications during the week before recruitment.

结局指标

主要结局

To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination.

时间窗: 1 day

To compare the self-reported extent and intensity of pain with selected tender points examination.

To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia.

时间窗: 1 day

To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Einat Mader

pricipal investigator

HaEmek Medical Center, Israel

研究点 (1)

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