Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
Relationship Between Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Taha Yasin YILDIRIM, M.D.
- 电话号码：+90 534 220 77 17
- 邮箱：tyasinyildirim.ftr@gmail.com
研究联系人备份
- 姓名：Hatice Gözde Sümer, M.D.
- 电话号码：+90 532 157 72 99
- 邮箱：gzdsmr@outlook.com
学习地点
-
-
-
Mardin、土耳其（türkiye）、47100
- 招聘中
- Mardin Training and Research Hospital
-
接触：
- Taha Yasin Yıldırım, M.D.
- 电话号码：+90 534 220 77 17
- 邮箱：tyasinyildirim.ftr@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional Impact Assessed by the Fibromyalgia Impact Questionnaire
大体时间：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.
|
At the initial visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Within-Person Association Between Pain and Fatigue
大体时间：During the 7-day monitoring period
|
Participants will rate pain and fatigue every morning and evening for seven days using 0-10 numerical rating scales.
The within-person correlation between paired pain and fatigue ratings will be calculated for each participant.
The relationship between this correlation and the FIQ total score will be examined.
|
During the 7-day monitoring period
|
|
Maximum Pain and Fatigue Levels
大体时间：During the 7-day monitoring period
|
The highest pain rating and the highest fatigue rating reported by each participant during the seven-day monitoring period will be identified separately.
Both are measured on scales from 0 to 10, with higher scores indicating greater symptom severity.
Their relationships with the FIQ total score will be examined.
|
During the 7-day monitoring period
|
|
Perceived Symptom Control
大体时间：During the 7-day monitoring period
|
Participants will rate their perceived control over their symptoms once daily for seven days using a scale from 0 to 10.
The relationship between perceived symptom control and the FIQ total score will be examined.
|
During the 7-day monitoring period
|
|
Sleep Quality
大体时间：During the 7-day monitoring period
|
Participants will rate the quality of the previous night's sleep each morning for seven days using a scale from 0 to 10.
The relationships of sleep quality with pain, fatigue, and the FIQ total score will be examined.
|
During the 7-day monitoring period
|
合作者和调查者
出版物和有用的链接
一般刊物
- Bartley EJ, Robinson ME, Staud R. Pain and Fatigue Variability Patterns Distinguish Subgroups of Fibromyalgia Patients. J Pain. 2018 Apr;19(4):372-381. doi: 10.1016/j.jpain.2017.11.014. Epub 2017 Dec 15.
- Affleck G, Urrows S, Tennen H, Higgins P, Abeles M. Sequential daily relations of sleep, pain intensity, and attention to pain among women with fibromyalgia. Pain. 1996 Dec;68(2-3):363-8. doi: 10.1016/s0304-3959(96)03226-5.
- Harris RE, Williams DA, McLean SA, Sen A, Hufford M, Gendreau RM, Gracely RH, Clauw DJ. Characterization and consequences of pain variability in individuals with fibromyalgia. Arthritis Rheum. 2005 Nov;52(11):3670-4. doi: 10.1002/art.21407.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.