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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Taha Yasin YILDIRIM, M.D.
- 電話番号：+90 534 220 77 17
- メール：tyasinyildirim.ftr@gmail.com
研究連絡先のバックアップ
- 名前：Hatice Gözde Sümer, M.D.
- 電話番号：+90 532 157 72 99
- メール：gzdsmr@outlook.com
研究場所
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Mardin、トルコ（Türkiye）、47100
- 募集
- Mardin Training and Research Hospital
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コンタクト：
- Taha Yasin Yıldırım, M.D.
- 電話番号：+90 534 220 77 17
- メール：tyasinyildirim.ftr@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional Impact Assessed by the Fibromyalgia Impact Questionnaire
時間枠：At the initial visit
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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.
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At the initial visit
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Within-Person Association Between Pain and Fatigue
時間枠：During the 7-day monitoring period
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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.
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During the 7-day monitoring period
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Maximum Pain and Fatigue Levels
時間枠：During the 7-day monitoring period
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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.
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During the 7-day monitoring period
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Perceived Symptom Control
時間枠：During the 7-day monitoring period
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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.
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During the 7-day monitoring period
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Sleep Quality
時間枠：During the 7-day monitoring period
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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.
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During the 7-day monitoring period
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。