Photobiomodulation in Chronic Fatigue Syndrome

NCT07546539 | Recruiting

• 1 other identifier: UOL/IREB/25/12/0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Quality of Life; Chronic Fatigue Syndrome (CFS)

Keywords

PHOTOBIOMODULATION; LOW-LEVEL LASER THERAPY; Chronic Fatigue Syndrome; Rehabilitation; Physiotherapy; Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue Improvement

  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.

  Baseline to Week 8-12 (end of intervention)

Secondary Outcomes (8)

• 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

Study Arms (2)

Sham Photobiomodulation (LLLT)

PLACEBO COMPARATOR

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.

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

Photobiomodulation Therapy (LLLT)

EXPERIMENTAL

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).

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

Interventions

Photobiomodulation (Low-Level Laser Therapy) DEVICE

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).

Photobiomodulation Therapy (LLLT); Sham Photobiomodulation (LLLT)

sham Photobiomodulation (LLLT) DEVICE

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.

Photobiomodulation Therapy (LLLT); Sham Photobiomodulation (LLLT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The larkana General hospital , larkana

Larkana, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Dr Adil Amir Ali Dr Aadil Amir Ali, PhD

CONTACT

923002929464; aadilamirali@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: June 15, 2026
• Primary Completion: July 15, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

PA (1)