Chronic Fatigue Syndrome (CFS)NCT07546539
Photobiomodulation in Chronic Fatigue Syndrome
A study testing Photobiomodulation (Low-Level Laser Therapy) in people with Chronic Fatigue Syndrome (CFS) and Quality of Life, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Fatigue Syndrome (CFS), Quality of Life
- What is being tested?
- Photobiomodulation (Low-Level Laser Therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
The larkana General hospital , larkana
Larkana, Sindh
Dr Naseebullah, 923337201393, larkanageneralhospital@gmail.com
ADIL AMIR ALI
About this study
Official title: The Role of Photobiomodulation in Patients With Chronic Fatigue Syndrome
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:
Read more
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
- Chronic Fatigue Syndrome (CFS), Quality of Life
- Being tested
- Photobiomodulation (Low-Level Laser Therapy), sham Photobiomodulation (LLLT)
- Keywords
- PHOTOBIOMODULATION, LOW-LEVEL LASER THERAPY, Chronic Fatigue Syndrome, Rehabilitation, Physiotherapy, Fatigue
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Photobiomodulation (Low-Level Laser Therapy); Device: sham Photobiomodulation (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8-12 (end of intervention)
Secondary outcomes (8)
Health Related Quality of Life
Quality of life will be assessed using either the Medical Outcomes Study 36-Item Short Form Health Survey (Short Form-36 Health Survey) or the World Health Organization Quality of Life Brief Version (World Health Organization Quality of Life-BREF).
The Short Form-36 Health Survey evaluates eight domains including physical functioning, bodily pain, vitality, and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life.
The World Health Organization Quality of Life-BREF consists of 26 items covering physical, psychological, social, and environmental domains, with higher scores indicating better perceived quality of life.
Measured: Baseline to Week 8-12
Functional Capacity
Functional capacity will be assessed using the Six-Minute Walk Test (Six-Minute Walk Test). This test measures the total distance (in meters) a participant can walk in six minutes on a flat surface and reflects submaximal aerobic capacity and endurance.
Measured: Baseline to Week 8-12 (end of intervention)
Pain Intensity
Pain intensity will be measured using the Visual Analog Scale (Visual Analog Scale), a 10-centimeter horizontal line ranging from "no pain" to "worst imaginable pain." Scores are recorded in centimeters, with higher scores indicating greater pain intensity.
Measured: Baseline to Week 8-12
Sleep Quality
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index). This 19-item questionnaire assesses sleep quality over the past month across seven components. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline to Week 8-12
Psychological Well-Being
Psychological well-being will be assessed using either the Hospital Anxiety and Depression Scale (Hospital Anxiety and Depression Scale) or the Beck Depression Inventory (Beck Depression Inventory).
The Hospital Anxiety and Depression Scale includes 14 items divided into anxiety and depression subscales, each scored from 0 to 21.
The Beck Depression Inventory is a 21-item self-report questionnaire with scores ranging from 0 to 63, where higher scores indicate more severe depressive symptoms.
Measured: Baseline to Week 8-12
Sustained Effects
Follow-up assessments will be conducted to determine whether improvements in fatigue, pain, and functional capacity are sustained after completion of the intervention.
Measured: Week 16 and Week 24 follow-up
Safety and Tolerability
Safety and tolerability will be assessed by monitoring participant-reported discomfort, skin irritation, or other minor side effects occurring during or after Photobiomodulation therapy sessions.
Measured: Throughout Week 8-12 intervention period
Adverse Effects and Safety Profile
All adverse events will be recorded and categorized by type, severity, duration, and relationship to the intervention. Serious adverse events will be reported immediately in accordance with regulatory requirements.
Measured: From baseline through Week 24 (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Jun 2026
- Primary completion15 Dec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue Syndrome (CFS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aadil Ameer Ali, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546539
- Sponsor's protocol ID
- UOL/IREB/25/12/0001
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Photobiomodulation in Patients With Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT07546539
- Acronym / sponsor ID
- UOL/IREB/25/12/0001
- Conditions
- Chronic Fatigue Syndrome (CFS), Quality of Life
- Keywords
- PHOTOBIOMODULATION, LOW-LEVEL LASER THERAPY, Chronic Fatigue Syndrome, Rehabilitation, Physiotherapy, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Photobiomodulation (LLLT) | Placebo comparator | Device: Photobiomodulation (Low-Level Laser Therapy), Device: sham Photobiomodulation (LLLT)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. |
| Photobiomodulation Therapy (LLLT) | Experimental | Device: Photobiomodulation (Low-Level Laser Therapy), Device: sham Photobiomodulation (LLLT)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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 muscle). Sessions will be conducted three times per week for 8 weeks (total 24 sessions). | Device | Photobiomodulation Therapy (LLLT), Sham Photobiomodulation (LLLT) |
| 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. | Device | Photobiomodulation Therapy (LLLT), Sham Photobiomodulation (LLLT) |
Primary outcome
Fatigue Improvement
Time frame: Baseline to Week 8-12 (end of intervention)
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Related trials for Chronic Fatigue Syndrome (CFS)
RecruitingPhase 2
LIFT: Life Improvement Trial
ME/CFS, Long COVID
Not yet recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 2
Low-Dose Naltrexone For ME/CFS: Dose-Finding
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
RecruitingPhase 2/3
RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
Chronic Fatigue Syndrome (CFS), Post-COVID ME/CFS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation (Low-Level Laser Therapy) in people with Chronic Fatigue Syndrome (CFS) and Quality of Life, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Adil Amir Ali Dr Aadil Amir Ali, PhD (923002929464, aadilamirali@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Improvement (time frame: Baseline to Week 8-12 (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.