- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07546539
Fotobiomodulation ved kronisk træthedssyndrom
Rollen af fotobiomodulering hos patienter med kronisk træthedssyndrom
Formålet med denne kliniske undersøgelse er at vurdere, om fotobiomodulationsterapi (low-level laserterapi) kan reducere træthed og forbedre livskvaliteten hos patienter med kronisk træthedssyndrom (CFS). Undersøgelsen vil inkludere voksne i alderen 18-60 år diagnosticeret med kronisk træthedssyndrom.
De vigtigste spørgsmål, den sigter mod at besvare, er:
Reducerer fotobiomodulationsterapi træthedsniveauer signifikant målt ved Fatigue Severity Scale (FSS) og Multidimensional Fatigue Inventory (MFI-20)? Forbedrer fotobiomodulationsterapi smerter, funktionel kapacitet, søvnkvalitet og psykisk velvære hos patienter med kronisk træthedssyndrom?
Forskerne vil sammenligne low-level laserterapigruppen med en placebo (sham-laser) gruppe for at afgøre, om fotobiomodulationsterapi fører til større forbedringer i træthed, smerter og samlet livskvalitet.
Deltagerne vil:
Modtage enten aktiv low-level laserterapi eller placebobehandling tre gange om ugen i otte uger Gennemgå vurderinger af træthed, smerter, funktionel kapacitet, livskvalitet, søvnkvalitet og psykisk velvære ved baseline og opfølgningsintervaller (3, 6 og 12 måneder)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
Diagnose af CFS i henhold til Institute of Medicines kriterier fra 2015 Fatigue Severity Scale (FSS) score ≥ 4 Evne til at forstå undersøgelsesprocedurer og give informeret samtykke
Eksklusionskriterier:
Komorbide psykiske lidelser (f.eks. alvorlig depression, skizofreni) Nuværende brug af kortikosteroider eller immunmodulatorer Kendt lysfølsomhed eller dermatologisk kontraindikation for LLLT Deltagelse i struktureret motionsprogrammer mere end to gange om ugen Diagnosticeret malignitet eller aktiv infektion Ikke villig til at deltage i undersøgelsen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: 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.
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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 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.
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Eksperimentel: Photobiomodulation Therapy (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). |
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 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fatigue Improvement
Tidsramme: Baseline to Week 8-12 (end of intervention)
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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)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Health Related Quality of Life
Tidsramme: Baseline to Week 8-12
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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. |
Baseline to Week 8-12
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Functional Capacity
Tidsramme: Baseline to Week 8-12 (end of intervention)
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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.
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Baseline to Week 8-12 (end of intervention)
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Pain Intensity
Tidsramme: Baseline to Week 8-12
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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.
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Baseline to Week 8-12
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Sleep Quality
Tidsramme: Baseline to Week 8-12
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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.
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Baseline to Week 8-12
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Psychological Well-Being
Tidsramme: Baseline to Week 8-12
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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. |
Baseline to Week 8-12
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Sustained Effects
Tidsramme: Week 16 and Week 24 follow-up
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Follow-up assessments will be conducted to determine whether improvements in fatigue, pain, and functional capacity are sustained after completion of the intervention.
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Week 16 and Week 24 follow-up
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Safety and Tolerability
Tidsramme: Throughout Week 8-12 intervention period
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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.
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Throughout Week 8-12 intervention period
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Adverse Effects and Safety Profile
Tidsramme: From baseline through Week 24 (study completion)
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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.
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From baseline through Week 24 (study completion)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neuroinflammatoriske sygdomme
- Muskuloskeletale sygdomme
- Sygdomme i nervesystemet
- Muskelsygdomme
- Patologiske processer
- Encephalomyelitis
- Neuromuskulære sygdomme
- Kronisk sygdom
- Sygdomsegenskaber
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Træthedssyndrom, kronisk
- Træthed
- Terapeutik
- Laserterapi
- Fototerapi
- Lysbehandling på lavt niveau
Andre undersøgelses-id-numre
- UOL/IREB/25/12/0001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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