Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia (REFLEX-FM)
The Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia: A Randomized Controlled Trial
調査の概要
状態
条件
詳細な説明
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and impaired quality of life. Women represent the majority of affected individuals, and many patients continue to experience persistent symptoms despite pharmacological treatment. Reflexology is a non-invasive complementary therapy involving pressure application to specific foot reflex zones and has been proposed as an adjunctive intervention for symptom management in fibromyalgia.
This study is a prospective single-blinded randomized controlled trial designed to evaluate the effect of reflexology on pain, sleep quality, psychological distress, and functional activity in female patients with fibromyalgia.
Sixty Egyptian female participants aged 18-65 years who meet fibromyalgia diagnostic criteria will be recruited and randomly allocated into two equal groups. The control group will receive conventional physical therapy consisting of aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS). The experimental group will receive the same conventional physical therapy program in addition to foot reflexology.
Both groups will receive treatment twice weekly for six weeks. Outcome measures will be assessed at baseline and post-treatment and include pressure pain threshold using algometry, the Arabic Fibromyalgia Impact Questionnaire, Arabic Pittsburgh Sleep Quality Index, Arabic Hospital Anxiety and Depression Scale, and Arabic Short Form-36 Health Survey.
The study seeks to determine whether adding foot reflexology to conventional physical therapy improves pain, sleep quality, psychological status, and functional outcomes in women with fibromyalgia.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ghada M Mohamed El-Hady Ismaeil, BSc, PT
- 電話番号：+201005677669
- メール：10722018823327@pg.cu.edu.eg
研究場所
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Dakahlia Governorate
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Al Mansurah、Dakahlia Governorate、エジプト、35744
- 募集
- Dekernis General Hospital
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コンタクト：
- Ghada M Mohamed El-Hady Ismaeil, BSc, PT
- 電話番号：+201005677669
- メール：10722018823327@pg.cu.edu.eg
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主任研究者：
- Ghada M Mohamed El-Hady Ismaeil, BSc, PT
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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
説明
Inclusion Criteria:
- Egyptian female participants aged 18 to 65 years
- Diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria
- Moderate pain intensity
- Poor sleep quality
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Comorbid conditions affecting pain or sleep, including rheumatoid arthritis and related disorders
- Previous reflexology treatment within the previous 6 months
- Any medical condition preventing participation in physical therapy or reflexology intervention
- Refusal or inability to comply with study procedures and follow-up requirements
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Control Group
Participants will receive conventional physical therapy including aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS) twice weekly for six weeks.
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Conventional physical therapy includes aerobic exercise, stretching, and low-load resistance training administered twice weekly for six weeks.
Exercise programs will be individualized and progressively adjusted according to participant tolerance.
High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
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実験的：Experimental Group
Participants will receive conventional physical therapy in addition to foot reflexology twice weekly for six weeks.
Conventional physical therapy includes aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS).
Foot reflexology sessions will be conducted for 30 minutes per session following standardized reflexology protocols.
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Conventional physical therapy includes aerobic exercise, stretching, and low-load resistance training administered twice weekly for six weeks.
Exercise programs will be individualized and progressively adjusted according to participant tolerance.
High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
Foot reflexology will be delivered twice weekly for six weeks, with each session lasting 30 minutes.
Moderate thumb and finger pressure will be applied bilaterally to standardized foot reflex zones associated with fibromyalgia symptom management.
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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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Pressure Pain Threshold (PPT)
時間枠：Baseline and 6 weeks
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Pressure pain threshold will be assessed using a digital pressure algometer at predefined tender points.
Three measurements will be obtained and averaged for analysis.
Higher values indicate reduced pain sensitivity.
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Baseline and 6 weeks
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Fibromyalgia Symptom Impact (FIQ-A)
時間枠：Baseline and 6 weeks
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Fibromyalgia symptom impact will be assessed using the Arabic version of the Fibromyalgia Impact Questionnaire (FIQ-A).
Scores range from 0 to 100, with higher scores indicating greater disease impact and symptom burden.
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Baseline and 6 weeks
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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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Sleep Quality (PSQI-A)
時間枠：Baseline and 6 weeks
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Sleep quality will be assessed using the Arabic version of the Pittsburgh Sleep Quality Index (PSQI-A).
The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality and greater sleep disturbance.
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Baseline and 6 weeks
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Psychological Distress (HADS)
時間枠：Baseline and 6 weeks
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Psychological distress will be evaluated using the Arabic Hospital Anxiety and Depression Scale (HADS), including anxiety and depression subscales.
Each subscale score ranges from 0 to 21 and the total score ranges from 0 to 42.
Higher scores indicate greater psychological distress.
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Baseline and 6 weeks
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Functional Activity and Health-Related Quality of Life (SF-36v2)
時間枠：Baseline and 6 weeks
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Functional activity and health-related quality of life will be assessed using the Arabic version of the Short Form-36 Health Survey Version 2 (SF-36v2).
Scores range from 0 to 100, with higher scores indicating better health status, physical functioning, and quality of life.
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Baseline and 6 weeks
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Akin Korhan E, Uyar M, Eyigor C, Yont GH, Khorshid L. Effects of Reflexology on Pain in Patients With Fibromyalgia. Holist Nurs Pract. 2016 Nov/Dec;30(6):351-359. doi: 10.1097/HNP.0000000000000178.
- Lee J, Han M, Chung Y, Kim J, Choi J. Effects of foot reflexology on fatigue, sleep and pain: a systematic review and meta-analysis. J Korean Acad Nurs. 2011 Dec;41(6):821-33. doi: 10.4040/jkan.2011.41.6.821.
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FPT-CU-REFLEX-FM-2026
- P.T.REC/012/006040 (その他の識別子：Research Ethical Committee, Faculty of Physical Therapy, Cairo University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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