Photobiomodulation in Chronic Fatigue Syndrome

Официальное название

The Role of Photobiomodulation in Patients With Chronic Fatigue Syndrome

Обзор

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)

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• The larkana General hospital , larkana — Larkana

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗