Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Symptom severity scale
研究概览
简要总结
Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with fibromyalgia has been demonstrated in several studies. However, the effect of initial CS severity on treatment response in these patients is not fully known. In this study, it was aimed to investigate the severity of CS and its effect on treatment response in patients with fibromyalgia.
详细描述
Fibromyalgia is a disease characterized by chronic widespread pain and its etiology and pathophysiology are still unknown.It is considered to be the main member of the central sensitization-related disease group known as central sensitivity syndromes with impaired pain regulation.In various studies, hyperalgesia and allodynia, which are accepted as objective findings of central sensitization in patients with fibromyalgia, strengthen the relationship between fibromyalgia and central sensitization. The central sensitization inventory (CSI) was developed in 2012 to be used in the recognition of central sensitivity syndromes in patients with fibromyalgia. A score of 40 and above is accepted in favor of central sensitization in the scale, which consists of two parts, in which central sensitization-related symptoms and diagnoses are questioned; scores of 30-39 are classified as mild, 40-49 moderate, 50-59 severe, and 60-100 very severe. Parallel to the increase in the CSI score, an increase is observed in patients' pain severity, disability, depressive symptoms and sleep disorders.In addition, it has been reported in the literature that factors such as pre-treatment pain severity and depression affect the treatment response.Considering all these factors, it is possible that there is a relationship between the severity of central sensitization and treatment response in patients with fibromyalgia.Based on this, in this study, it was aimed to investigate the effect of central sensitization severity, which was evaluated with CSI before treatment, on the treatment process.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosing fibromyalgia according to ACR 2016 criteria
- •Between the ages of 18-65
- •Agree to participate in the study
排除标准
- •History of concomitant systemic inflammatory disease, active infection and malignancy
- •Refusing to participate in the study
研究组 & 干预措施
Patients with fibromyalgia
Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
干预措施: Duloxetine (Drug)
Patients with fibromyalgia
Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
干预措施: Pregabalin (Drug)
Patients with fibromyalgia
Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
干预措施: Amitriptyline (Drug)
结局指标
主要结局
Symptom severity scale
时间窗: 2 year
The SS scale quantifies symptom severity on a 0-12 scale by scoring problems with fatigue, cognitive dysfunction and unrefreshed sleep over the past week
Fibromyalgia impact scale
时间窗: 2 year
The questionnaire was developed to determine the degree of being affected by the disease in patients with a diagnosis of fibromyalgia.The scale consists of 10 parts in total, and the first part is a Likert scale containing 11 questions. High scores indicate that the patient is overly affected.
Visual analog scale ( VAS) pain
时间窗: 2 year
Pain rating scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Short Form-36
时间窗: 2 year
Standardized questionnaire to investigate the quality of life in patients. The score of the scale is between 0-100. The higher scores are associated with greater deterioration in quality of life.
Central sensitization inventory
时间窗: 2 year
Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.
次要结局
未报告次要终点