Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
Systemic sclerosis [SSc]; is a multisystem disease characterized by immune activation, microvascular disease and fibroblast dysfunction, which is thought to occur as a result of complex and not fully understood interaction between genetic and environmental factors, leading to fibrotic changes in the skin and some internal organs. It is characterized by the deposition of collagen and other matrix components in the skin and some internal organs. It has been shown by evaluating the health assessment questionnaire that it causes disability with increasing frequency over time.
Although pain cannot be localized too well to be attributed to a particular anatomical area, there are several musculoskeletal pain syndromes that can be detected in patients with systemic sclerosis. These are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and fibromyalgia. While there are several studies on others, the relationship between fibromyalgia syndrome and SSc is not known clearly. As with other connective tissue diseases, fibromyalgia is not considered to be rare in SSc.
详细描述
There are a few studies on this subject. Except for one of these studies, the sensitive point in ACR 1990 FMS diagnostic criteria set was evaluated. In 2010, ACR published new criteria, which may be an alternative method in clinical practice, without sensitive points, including the common pain index and symptom severity scale. It is evaluated with the common pain index and symptom severity scale. This new set of criteria alone is not affected by pain, it is based on patient reporting. Therefore, it seems clinically more significant in determining the origin of pain in autoimmune diseases. There was only one study in the literature in which SSc patients are evaluated with the 2010 FMS criteria set . Therefore, the aim of our study was to evaluate the frequency of FMS according to 2010 FMS criteria and to investigate its effect on quality of life in our study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •SSc diagnosis is definitive and diffuse involvement
- •no additional disease known other than scleroderma (Diabetes mellitus, hypertension etc.)
- •no known additional rheumatic diseases
排除标准
- •To have depression and / or any psychiatric illness
- •To use steroid, antidepressant, antiepileptic, regular NSAID usage.
结局指标
主要结局
Beck Depression Inventory
时间窗: 1 week
It assesses risk for depression as well as level and changes in severity of depressive symptoms in the patients. This scale was developed by Beck et al. in 1961. BDI is self-reported assessment scale including 21 self-assessment statements which are rated by using 4-points Likert scale. Turkish validity and reliability was proven
Beck anxiety inventory
时间窗: 1 week
It was developed by Beck et al. in 1988. It is a scale that measures the severity of anxiety symptoms experienced by individuals and is filled by the patient. Questions subjective subjective anxiety and physical symptoms. It consists of 21 items and it is scored between 0 and 3 likert type. The high scores in the scale indicate the severity of the anxiety experienced by the individual. Turkish validity and reliability study was made by Ulusoy et al.
Fibromyalgia Impact Questionnaire
时间窗: 1 week
The Fibromyalgia Impact Questionnaire \[FIQR\] was used to evaluate patients' functional status, disease progression, and outcomes. The Turkish validity study Sarmer et al. This questionnaire consists of 20 questions that question physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Item 1 is scored between 0-3. Other items range from 0-10 points.The total score ranges from 0-80. 80 points indicate high effectiveness.
次要结局
- Short Form-36(1 week)
研究者
Ayse Ayan
Principal Investigator
Antalya Training and Research Hospital