慢性疲劳综合征中的光生物调节
光生物调节在慢性疲劳综合征患者中的作用
本临床试验旨在评估光生物调节疗法（低强度激光疗法）能否减轻慢性疲劳综合征（CFS）患者的疲劳程度并改善其生活质量。 研究将纳入年龄在18-60岁之间、被诊断为慢性疲劳综合征的成人患者。
研究旨在回答的主要问题包括：
光生物调节疗法是否能显著降低通过疲劳严重程度量表（FSS）和多维疲劳量表（MFI-20）测量的疲劳水平？ 光生物调节疗法是否能改善慢性疲劳综合征患者的疼痛、功能能力、睡眠质量和心理健康？
研究人员将比较低强度激光治疗组与安慰剂（假激光）组，以确定光生物调节疗法是否在疲劳、疼痛和整体生活质量方面带来更大改善。
参与者将：
在八周内每周接受三次积极的低强度激光治疗或安慰剂治疗，并在基线和随访期间（3个月、6个月和12个月）接受疲劳、疼痛、功能能力、生活质量、睡眠质量和心理健康的评估。
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dr Adil Amir Ali Dr Aadil Amir Ali, PhD
- 电话号码：923002929464
- 邮箱：aadilamirali@hotmail.com
学习地点
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Sindh
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Larkana、Sindh、巴基斯坦
- 招聘中
- The larkana General hospital , larkana
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接触：
- Dr Naseebullah
- 电话号码：923337201393
- 邮箱：larkanageneralhospital@gmail.com
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首席研究员：
- ADIL AMIR ALI
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
纳入标准：
根据2015年医学研究所标准诊断为慢性疲劳综合征 疲劳严重程度量表（FSS）评分≥4 能够理解研究程序并提供知情同意
排除标准：
共病精神疾病（例如，重度抑郁症、精神分裂症） 当前使用皮质类固醇或免疫调节剂 已知对LLLT有光敏性或皮肤病禁忌症 每周参加结构化运动项目超过两次 确诊恶性肿瘤或活动性感染 不愿参与本研究
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：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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实验性的：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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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 |
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Fatigue Improvement
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health Related Quality of Life
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
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
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