Photobiomodulation in Chronic Fatigue Syndrome

University of Lahore

Status: Not yet enrolling

Conditions: Chronic Fatigue Syndrome (CFS); Quality of Life

Treatments: Device: sham Photobiomodulation (LLLT); Device: Photobiomodulation (Low-Level Laser Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07546539

UOL/IREB/25/12/0001

Details and patient eligibility

About

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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Sham Photobiomodulation (LLLT)

Placebo Comparator group

Description:

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.

Treatment:

Device: Photobiomodulation (Low-Level Laser Therapy)

Device: sham Photobiomodulation (LLLT)

Photobiomodulation Therapy (LLLT)

Experimental group

Description:

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).

Treatment:

Device: Photobiomodulation (Low-Level Laser Therapy)

Device: sham Photobiomodulation (LLLT)