Chronic Fatigue Syndrome (CFS), Quality of Life
Conditions
Keywords
PHOTOBIOMODULATION, LOW-LEVEL LASER THERAPY, Chronic Fatigue Syndrome, Rehabilitation, Physiotherapy, Fatigue
Brief summary
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)
Interventions
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).
DEVICEsham Photobiomodulation (LLLT)
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.
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Improvement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | Baseline to Week 8-12 | 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. |
| Functional Capacity | Baseline to Week 8-12 (end of intervention) | 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. |
| Pain Intensity | Baseline to Week 8-12 | 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. |
| Sleep Quality | Baseline to Week 8-12 | 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. |
| Psychological Well-Being | Baseline to Week 8-12 | 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. |
| Sustained Effects | Week 16 and Week 24 follow-up | Follow-up assessments will be conducted to determine whether improvements in fatigue, pain, and functional capacity are sustained after completion of the intervention. |
| Safety and Tolerability | Throughout Week 8-12 intervention period | 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. |
| Adverse Effects and Safety Profile | From baseline through Week 24 (study completion) | 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. |
Countries
Pakistan
Contacts
CONTACTDr Adil Amir Ali Dr Aadil Amir Ali, PhD
Outcome results
None listed