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临床试验/NCT05850442
NCT05850442已完成不适用

The Relationship Between Fibromyalgia Syndrome Parameters With Disease Severity, Pain and the Quality Of Life

Umraniye Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
Symptom Severity Score

研究概览

简要总结

In this study, the investigators aim to evaluate the relationship between disease severity, quality of life, anxiety and pain level in patients diagnosed with Fibromyalgia Syndrome (FMS) with the parameters according to the American College of Rheumatology (ACR) 2016 diagnostic criteria. According to the 2016 ACR diagnostic criteria, there are 2 separate scales: Widespread Pain Index (WPI) and Symptom Severity (SS) . The relationship between these 2 parameters and the Fibromyalgia Impact Questionnaire, the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire will be examined.

详细描述

The aim of this study is to observe the relationship between the WPI and SS parameters in the ACR 2016 criteria for fibromyalgia, separately, with the severity of the disease, pain level, quality of life and anxiety level. Accordingly, the investigators aim to evaluate whether WPI or SS has priority in assessing the severity of the disease. There is no study in the literature comparing the importance of the 2016 ACR diagnostic parameters on the disease effect. In this context, this study will be the first study in the literature and will be very valuable. Patients visiting the outpatient clinic with FMS diagnosis will be evaluated. Patients will be asked to fill the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire . The patients will be assed by an experienced Physical Medicine and Rehabilitation specialist for SS and WPI scores.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed as FMS according to ACR 2016 criterias

排除标准

  • History of Malignity
  • History of Rheumatological Disease

结局指标

主要结局

Symptom Severity Score

时间窗: at the start of the study

Symptom Severity Score. Ranging from 0-12. Higher scores mean higher symptom scores.

Widespread Pain Index Score

时间窗: at the start of the study

Widespread Pain Index Score, Ranging from 0-19. Higher scores mean higher pain scores.

次要结局

  • Beck Anxiety Score(at the start of the study)
  • WHO Short Quality of Life Score(at the start of the study)

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Özlem Kaleoğlu, MD

Principle Investigator

Umraniye Education and Research Hospital

研究点 (1)

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