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临床试验/NCT05481086
NCT05481086
已完成
不适用

The Effects Pain Severity on Individuals With Fibromyalgia Syndrome

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 93 人2022年8月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Fibromyalgia
发起方
Kutahya Health Sciences University
入组人数
93
试验地点
1
主要终点
Tampa Kinesiophobia Scale
状态
已完成
最后更新
2年前

概览

简要总结

Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. The existence and importance of the multidimensional nature of chronic pain in FMS has been demonstrated. Factors such as pain intensity, persistence of pain, pain-related disability, and novelty of onset are all important characteristics of a chronic pain condition. Therefore, there was a need for a global measure of chronic pain severity that summarized different measures of pain and a graded classification of chronic pain was proposed. Patients with chronic pain such as FMS are known to have a greater negative impact than many chronic medical conditions. Chronic pain severity in FMS has been found to be associated with various conditions such as function and health status, and it has been shown that reduction in pain severity provides broadly beneficial results on these conditions. However; there are no studies in which chronic pain severity in FMS is classified by grading and investigating the relationship of different pain severity degrees with disease severity and other symptoms.

The aim of this study is to evaluate whether the severity of the disease, kinesiophobia, and concerns about pain differ in individuals with different pain severity by grading the severity of pain in individuals with fibromyalgia syndrome.

注册库
clinicaltrials.gov
开始日期
2022年8月15日
结束日期
2023年10月28日
最后更新
2年前
研究类型
Observational
性别
All

研究者

发起方
Kutahya Health Sciences University
责任方
Principal Investigator
主要研究者

Ismail Saracoglu

Director

Kutahya Health Sciences University

入排标准

入选标准

  • to be aged between 18-65,
  • to be diagnosed with fibromyalgia syndrome according to the criteria of 2016 ACR
  • to be volunteer to participate in the study.

排除标准

  • Having cognitive impairment
  • Illiterate people
  • Diagnosed severe mental and psychological disorders

结局指标

主要结局

Tampa Kinesiophobia Scale

时间窗: 10 minutes

"Tampa Kinesiophobia Scale (TKS)" will be used to evaluate kinesiophobia. The Turkish version was created by Yılmaz et al (7). The scale consists of 17 questions developed to measure the fear of movement and/or re-injury.

UW-Concerns About Pain

时间窗: 5 minutes

Participants' pain concerns will be assessed with the "University of Washington Concerns About Pain (UWCAP)", which was recently developed as a pain self-efficacy measure based on modern scale development approaches. The scale was adapted to Turkish by Saraçoğlu et al (UWCAP-TR-6). "UWCAP-TR-6" consists of 6 questions.

Chronic Pain Grading Scale-Revised (CPGS-R)

时间窗: 5 minutes

Pain severity and degree will be evaluated with the "Revised Graded Chronic Pain Scale (GCPS-R)". The "Graded Chronic Pain Scale" was created by Von Korff et al (1) to evaluate the severity of pain and disability related to pain in individuals with chronic pain. It has also been revised by the same authors (2). The Turkish validity and reliability study of the GCPS-R was performed by Özden et al (3).

Revised Fibromyalgia Impact Questionnaire

时间窗: 10 minutes

The Fibromyalgia Impact Questionnaire was developed by Burckhardt et al (4). The scale was revised by Bennett et al (5). The Turkish validity and reliability study of the FIQ-R was performed by Ediz et al (6). The structure of the FIQ-R's original questionnaire, based on function, overall effect, and severity of FM symptoms (disease severity) is the same as in the FIQ. However, questions assessing altered function, which were not part of the original FIQ, and questions measuring cognitive impairment, sensitivity, balance, and environmental sensitivity have been added to the FIQ-R. Also, some of the wording, missings, concepts and scoring problems in the original FIQ have been corrected in the FIQ-R. FIQ-R consists of 21 questions in total.

次要结局

  • Short form-12 (SF-12) questionnaire(5 minutes)

研究点 (1)

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