About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Photobiomodulation (Low-Level Laser Therapy)
  • sham Photobiomodulation (LLLT)

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

1
The larkana General hospital , larkana LarkanaSindh, Pakistan

Sponsors and collaborators

University of Lahore

Lead sponsor