The Role of Photobiomodulation in Patients With Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fatigue Improvement
研究概览
简要总结
The goal of this clinical trial is to evaluate whether photobiomodulation therapy (low-level laser therapy) can reduce fatigue and improve quality of life in patients with chronic fatigue syndrome (CFS). The study will include adults aged 18-60 years diagnosed with chronic fatigue syndrome.
The main questions it aims to answer are:
Does photobiomodulation therapy significantly reduce fatigue levels as measured by the Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI-20)? Does photobiomodulation therapy improve pain, functional capacity, sleep quality, and psychological well-being in patients with chronic fatigue syndrome?
Researchers will compare the low-level laser therapy group with a placebo (sham laser) group to determine whether photobiomodulation therapy leads to greater improvements in fatigue, pain, and overall quality of life.
Participants will:
Receive either active low-level laser therapy or placebo treatment three times per week for eight weeks Undergo assessments of fatigue, pain, functional capacity, quality of life, sleep quality, and psychological well-being at baseline and follow-up intervals (3, 6, and 12 months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Diagnosis of a CFS according to the 2015 Institute of Medicine criteria
- •Fatigue Severity Scale (FSS) score ≥ 4
- •Ability to understand study procedures and provide informed consent
排除标准
- •Comorbid psychiatric conditions (e.g., major depression, schizophrenia)
- •Current use of corticosteroids or immunomodulators
- •Known photosensitivity or dermatologic contraindications to LLLT
- •Participation in structured exercise programs more than twice weekly
- •Diagnosed malignancy or active infection -Not willing to be the part of study -
研究组 & 干预措施
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.
干预措施: sham Photobiomodulation (LLLT) (Device)
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).
干预措施: sham Photobiomodulation (LLLT) (Device)
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.
干预措施: Photobiomodulation (Low-Level Laser Therapy) (Device)
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).
干预措施: Photobiomodulation (Low-Level Laser Therapy) (Device)
结局指标
主要结局
Fatigue Improvement
时间窗: 8 TO 12 WEEKS
Measured using Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI-20)
Fatigue Improvement
时间窗: Baseline to Week 8-12 (end of intervention)
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.
次要结局
- Health Related Quality of Life(8 TO 12 WEEKS)
- Functional Capacity(8 TO 12 WEEKS)
- Pain Intensity(8 TO 12 WEEKS)
- Sleep Quality(8 TO 12 WEEKS)
- Psychological Well-Being(8 TO 12 WEEKS)
- Sustained Effects(8 TO 12 WEEKS)
- Safety and Tolerability(8 TO 12 WEEKS)
- Adverse Effects and Safety Profile(8 TO 12 WEEKS)
- Health Related Quality of Life(Baseline to Week 8-12)
- Functional Capacity(Baseline to Week 8-12 (end of intervention))
- Pain Intensity(Baseline to Week 8-12)
- Sleep Quality(Baseline to Week 8-12)
- Psychological Well-Being(Baseline to Week 8-12)
- Sustained Effects(Week 16 and Week 24 follow-up)
- Safety and Tolerability(Throughout Week 8-12 intervention period)
- Adverse Effects and Safety Profile(From baseline through Week 24 (study completion))
研究者
Aadil Ameer Ali
Prof
University of Lahore