慢性疲労症候群におけるフォトバイオモジュレーション
慢性疲労症候群患者におけるフォトバイオモジュレーションの役割
この臨床試験の目的は、光バイオモジュレーション療法（低出力レーザー療法）が、慢性疲労症候群（CFS）患者の疲労を軽減し、生活の質を改善できるかどうかを評価することです。 本研究には、慢性疲労症候群と診断された18歳から60歳の成人が含まれます。
本研究が解明しようとしている主な質問は以下の通りです：
光バイオモジュレーション療法は、Fatigue Severity Scale（FSS）およびMultidimensional Fatigue Inventory（MFI-20）で測定される疲労レベルを有意に軽減するか？ 光バイオモジュレーション療法は、慢性疲労症候群患者の痛み、機能的能力、睡眠の質、心理的幸福感を改善するか？
研究者は、低出力レーザー療法群とプラセボ（疑似レーザー）群を比較し、光バイオモジュレーション療法が疲労、痛み、および全体的な生活の質においてより大きな改善をもたらすかどうかを判断します。
参加者は以下のことを行います：
8週間にわたり週3回、有効な低出力レーザー療法またはプラセボ治療のいずれかを受ける。 疲労、痛み、機能的能力、生活の質、睡眠の質、心理的幸福感について、ベースライン時および追跡調査期間（3ヶ月、6ヶ月、12ヶ月）に評価を受ける。
調査の概要
状態
条件
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：Dr Adil Amir Ali Dr Aadil Amir Ali, PhD
- 電話番号：923002929464
- メール：aadilamirali@hotmail.com
研究場所
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Sindh
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Larkana、Sindh、パキスタン
- 募集
- The larkana General hospital , larkana
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コンタクト：
- Dr Naseebullah
- 電話番号：923337201393
- メール：larkanageneralhospital@gmail.com
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主任研究者：
- ADIL AMIR ALI
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
包含基準：
2015年米国医学研究所基準に基づく慢性疲労症候群（CFS）の診断 疲労重症度スケール（FSS）スコア≧4 研究手順を理解し、インフォームドコンセントを提供できる能力
除外基準：
併存する精神疾患（例：大うつ病、統合失調症） 現在のコルチコステロイドまたは免疫調整剤の使用 既知の光線過敏症またはLLLTに対する皮膚科的禁忌 週2回を超える構造化運動プログラムへの参加 診断された悪性腫瘍または活動性感染症 研究への参加を希望しない
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Sham Photobiomodulation (LLLT)
Participants in this group will receive sham laser therapy using an identical device with no therapeutic laser emission.
The device will be applied in the same manner, duration, and frequency as the experimental group to maintain blinding.
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Low-level laser therapy will be delivered using a Class 3B laser device (808 nm wavelength, 100 mW power output). The laser will be applied in contact mode using a static technique perpendicular to the skin surface. Treatment will target bilateral muscle groups: upper trapezius, biceps brachii, posterior deltoid, lumbar paraspinals, gluteus maximus, and vastus lateralis. Each muscle will receive irradiation at 16 points spaced 1 cm apart, delivering 4 Joules per point (total 64 Joules per muscle). Sessions will be conducted three times per week for 8 weeks (total 24 sessions).
Sham laser therapy will be administered using the same device without emission of therapeutic laser energy.
The device will appear active and will be applied with identical procedures, duration, and frequency as the active treatment to ensure participant blinding.
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実験的：Photobiomodulation Therapy (LLLT)
Participants in this group will receive low-level laser therapy applied bilaterally to multiple muscle groups, including upper trapezius, biceps brachii, posterior deltoid, lumbar paraspinals, gluteus maximus, and vastus lateralis. Each muscle will be treated at 16 points spaced 1 cm apart, with an energy delivery of 4 Joules per point (total 64 Joules per muscle). The therapy will be administered three times per week for 8 weeks (total 24 sessions). |
Low-level laser therapy will be delivered using a Class 3B laser device (808 nm wavelength, 100 mW power output). The laser will be applied in contact mode using a static technique perpendicular to the skin surface. Treatment will target bilateral muscle groups: upper trapezius, biceps brachii, posterior deltoid, lumbar paraspinals, gluteus maximus, and vastus lateralis. Each muscle will receive irradiation at 16 points spaced 1 cm apart, delivering 4 Joules per point (total 64 Joules per muscle). Sessions will be conducted three times per week for 8 weeks (total 24 sessions).
Sham laser therapy will be administered using the same device without emission of therapeutic laser energy.
The device will appear active and will be applied with identical procedures, duration, and frequency as the active treatment to ensure participant blinding.
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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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Fatigue Improvement
時間枠：Baseline to Week 8-12 (end of intervention)
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Fatigue will be assessed using validated self-reported instruments to evaluate the effect of photobiomodulation therapy on chronic fatigue symptoms. The Fatigue Severity Scale (Fatigue Severity Scale) is a 9-item questionnaire that measures the impact of fatigue on daily functioning. Each item is scored on a 7-point Likert scale, and the final score is calculated as the mean of all items, with higher scores indicating greater fatigue severity. The Multidimensional Fatigue Inventory (Multidimensional Fatigue Inventory) is a 20-item instrument assessing five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each domain is scored on a 5-point Likert scale, with higher scores indicating increased fatigue. |
Baseline to Week 8-12 (end of intervention)
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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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Health Related Quality of Life
時間枠：Baseline to Week 8-12
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Quality of life will be assessed using either the Medical Outcomes Study 36-Item Short Form Health Survey (Short Form-36 Health Survey) or the World Health Organization Quality of Life Brief Version (World Health Organization Quality of Life-BREF). The Short Form-36 Health Survey evaluates eight domains including physical functioning, bodily pain, vitality, and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life. The World Health Organization Quality of Life-BREF consists of 26 items covering physical, psychological, social, and environmental domains, with higher scores indicating better perceived quality of life. |
Baseline to Week 8-12
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Functional Capacity
時間枠：Baseline to Week 8-12 (end of intervention)
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Functional capacity will be assessed using the Six-Minute Walk Test (Six-Minute Walk Test).
This test measures the total distance (in meters) a participant can walk in six minutes on a flat surface and reflects submaximal aerobic capacity and endurance.
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Baseline to Week 8-12 (end of intervention)
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Pain Intensity
時間枠：Baseline to Week 8-12
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Pain intensity will be measured using the Visual Analog Scale (Visual Analog Scale), a 10-centimeter horizontal line ranging from "no pain" to "worst imaginable pain."
Scores are recorded in centimeters, with higher scores indicating greater pain intensity.
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Baseline to Week 8-12
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Sleep Quality
時間枠：Baseline to Week 8-12
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Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index).
This 19-item questionnaire assesses sleep quality over the past month across seven components.
Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
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Baseline to Week 8-12
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Psychological Well-Being
時間枠：Baseline to Week 8-12
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Psychological well-being will be assessed using either the Hospital Anxiety and Depression Scale (Hospital Anxiety and Depression Scale) or the Beck Depression Inventory (Beck Depression Inventory). The Hospital Anxiety and Depression Scale includes 14 items divided into anxiety and depression subscales, each scored from 0 to 21. The Beck Depression Inventory is a 21-item self-report questionnaire with scores ranging from 0 to 63, where higher scores indicate more severe depressive symptoms. |
Baseline to Week 8-12
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Sustained Effects
時間枠：Week 16 and Week 24 follow-up
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Follow-up assessments will be conducted to determine whether improvements in fatigue, pain, and functional capacity are sustained after completion of the intervention.
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Week 16 and Week 24 follow-up
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Safety and Tolerability
時間枠：Throughout Week 8-12 intervention period
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Safety and tolerability will be assessed by monitoring participant-reported discomfort, skin irritation, or other minor side effects occurring during or after Photobiomodulation therapy sessions.
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Throughout Week 8-12 intervention period
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Adverse Effects and Safety Profile
時間枠：From baseline through Week 24 (study completion)
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All adverse events will be recorded and categorized by type, severity, duration, and relationship to the intervention.
Serious adverse events will be reported immediately in accordance with regulatory requirements.
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From baseline through Week 24 (study completion)
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協力者と研究者
スポンサー
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。