Relationship Between Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional Impact Assessed by the Fibromyalgia Impact Questionnaire
研究概览
简要总结
Fibromyalgia is a chronic condition that commonly causes widespread pain, fatigue, and difficulty in daily activities. These symptoms may change from day to day, even when their average severity is similar.
This study aims to examine whether daily changes in pain and fatigue are related to functional impact in adults with fibromyalgia. Participants will complete clinical questionnaires at the first visit and record their pain and fatigue levels for seven days. Sleep quality and perceived control over symptoms will also be recorded. No treatment or additional medical procedure will be given as part of the study.
详细描述
Fibromyalgia symptoms do not always remain at the same level. Pain and fatigue may increase or decrease between days and may also change between morning and evening. Clinical assessments usually focus on the average severity of these symptoms. However, patients with similar average pain or fatigue levels may have different levels of difficulty in daily life. This study will therefore examine whether symptom fluctuation provides additional information about functional impact beyond average symptom severity.
Adults diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria will be included. At the initial visit, demographic and clinical information will be recorded. Functional impact will be assessed using the Fibromyalgia Impact Questionnaire. Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale, and symptoms related to central sensitization will be assessed using the Central Sensitization Inventory.
After the initial visit, participants will record pain and fatigue levels every morning and evening for seven days using 0-10 numerical rating scales. They will also record their sleep quality each morning and their perceived control over symptoms once daily. These records will be used to calculate average pain and fatigue levels, daily fluctuations in these symptoms, maximum symptom levels, and the degree to which pain and fatigue change together within each participant.
The main analysis will examine the relationship between pain and fatigue fluctuations and functional impact. It will also evaluate whether symptom fluctuation is related to functional impact after considering average pain and fatigue levels, age, sex, and disease duration. Additional analyses will examine the relationships of pain-fatigue synchrony, sleep quality, maximum symptom levels, and perceived symptom control with functional impact. The study is observational and is not designed to determine cause-and-effect relationships.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
- •Age between 18 and 65 years
- •Ability to understand and complete the daily symptom records
- •Ability and willingness to provide written informed consent
排除标准
- •Active inflammatory rheumatic disease
- •Major neurological disease
- •Major change in fibromyalgia treatment within the previous three months
- •Pregnancy, postpartum period, or breastfeeding
- •Cognitive impairment or inability to provide informed consent
- •Completion of less than 70% of the required daily symptom records
- •Major change in fibromyalgia treatment during the seven-day monitoring period
研究组 & 干预措施
Adults With Fibromyalgia
Adults aged 18-65 years who meet the 2016 American College of Rheumatology criteria for fibromyalgia will be included. Participants will complete clinical questionnaires at the initial visit and record pain and fatigue levels for seven days. Sleep quality and perceived symptom control will also be recorded. No treatment or experimental intervention will be administered as part of the study.
结局指标
主要结局
Functional Impact Assessed by the Fibromyalgia Impact Questionnaire
时间窗: At the initial visit
Functional impact will be assessed using the Fibromyalgia Impact Questionnaire (FIQ). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia. The main analysis will examine whether within-person variability in pain and fatigue over seven days is associated with the FIQ score independently of average pain and fatigue levels.
次要结局
- Within-Person Association Between Pain and Fatigue(During the 7-day monitoring period)
- Maximum Pain and Fatigue Levels(During the 7-day monitoring period)
- Perceived Symptom Control(During the 7-day monitoring period)
- Sleep Quality(During the 7-day monitoring period)
研究者
Hatice Gözde Sümer
M.D.
Mardin Artuklu University