The Role of Photobiomodulation in Patients With Chronic Fatigue Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fatigue Improvement
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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 -
Arms & Interventions
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.
Intervention: 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).
Intervention: 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.
Intervention: 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).
Intervention: Photobiomodulation (Low-Level Laser Therapy) (Device)
Outcomes
Primary Outcomes
Fatigue Improvement
Time Frame: 8 TO 12 WEEKS
Measured using Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI-20)
Fatigue Improvement
Time Frame: 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 Outcomes
- 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))
Investigators
Aadil Ameer Ali
Prof
University of Lahore