Photobiomodulation in Chronic Fatigue Syndrome

Official title

The Role of Photobiomodulation in Patients With Chronic Fatigue Syndrome

Overview

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

• Device Photobiomodulation (Low-Level Laser Therapy)
  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 muscl
• Device sham 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.

Primary outcome measures

• Fatigue Improvement [Time frame: Baseline to Week 8-12 (end of intervention)]

Secondary outcome measures (8)

• Health Related Quality of Life [Time frame: Baseline to Week 8-12]
• Functional Capacity [Time frame: Baseline to Week 8-12 (end of intervention)]
• Pain Intensity [Time frame: Baseline to Week 8-12]
• Sleep Quality [Time frame: Baseline to Week 8-12]
• Psychological Well-Being [Time frame: Baseline to Week 8-12]
• Sustained Effects [Time frame: Week 16 and Week 24 follow-up]
• Safety and Tolerability [Time frame: Throughout Week 8-12 intervention period]
• Adverse Effects and Safety Profile [Time frame: From baseline through Week 24 (study completion)]

Eligibility 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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• The larkana General hospital , larkana — Larkana

Identifiers

NCT: NCT07546539 · UOL/IREB/25/12/0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗