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Effects of High-Intensity Laser Therapy Combined With Exercise in Patients With Knee Osteoarthritis (HILT-KOA)

1 juni 2026 bijgewerkt door: Ivan Silva-Satlov, Universidad Metropolitana de Ciencias de la Educacion

Effects of High-intensity Laser Therapy on Muscle Strength in People With Knee Osteoarthritis

The goal of this clinical trial was to determine whether high-intensity laser therapy (HILT) combined with exercise improves pain, physical function, and muscle strength in people with knee osteoarthritis.

The main questions the study aimed to answer were:

  • Did HILT combined with exercise lower pain more than sham laser combined with exercise?
  • Did HILT combined with exercise improve physical function more than sham laser combined with exercise?
  • Did HILT combined with exercise improve knee extensor muscle strength more than sham laser combined with exercise?

Researchers compared HILT plus exercise with sham laser plus exercise to determine whether HILT provided additional benefits beyond those achieved with exercise alone.

Participants:

  • Received either HILT or sham laser treatment for four weeks.
  • Participated in a standardized exercise program.
  • Completed assessments of pain, physical function, and muscle strength before and after treatment.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Knee osteoarthritis is a common musculoskeletal condition associated with pain, reduced physical function, and muscle weakness. Exercise therapy is widely recommended as a first-line treatment; however, the additional benefits of high-intensity laser therapy (HILT) remain uncertain. Previous studies have reported improvements in pain and function following HILT, but results have been inconsistent, and its effects on muscle strength have not been fully established.

The purpose of this randomized, participant-blinded, sham-controlled clinical trial was to evaluate the effects of HILT combined with exercise on pain, physical function, and knee extensor muscle strength in people with knee osteoarthritis.

Participants with clinically diagnosed knee osteoarthritis were randomly assigned to one of two groups. The experimental group received HILT combined with a standardized exercise program, while the control group received sham laser treatment combined with the same exercise program. The intervention lasted four weeks and included ten treatment sessions.

Pain intensity, physical function, and knee extensor muscle strength were assessed before and after the intervention using validated clinical outcome measures. The primary objective was to determine whether HILT provides additional benefits beyond those achieved with exercise alone.

The findings of this study may help clarify the role of HILT as an adjunct treatment in rehabilitation programs for people with knee osteoarthritis and contribute to the development of evidence-based clinical recommendations.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

31

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Chili
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chili, 7760197
        • Departamento de Kinesiología

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Clinical diagnosis of knee osteoarthritis.
  • Age between 45 and 77 years.
  • Pain intensity of at least 3 points on the Visual Analogue Scale (VAS).

Exclusion Criteria:

  • Presence of other musculoskeletal conditions affecting the lower limbs.
  • History of lower limb surgery.
  • Tattoos in the laser application area.
  • Recent intra-articular corticosteroid injection.
  • Comorbidities limiting participation in physical exercise, such as chronic obstructive pulmonary disease, stroke, or severe heart failure.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: High Intensity Laser Therapy + Exercise
Participants received high-intensity laser therapy (HILT) combined with a standardized exercise program. HILT was delivered using an MLS laser device (MPHI D, ASA Laser, Italy) over four periarticular knee application points during 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises and was identical to that provided to the sham comparator group.
Apparaat: High Intensity Laser Therapy
High-intensity laser therapy (HILT) was delivered using an MLS laser device (MPHI D, ASA Laser, Italy), which combines synchronized 808 nm and 905 nm wavelengths. Treatment was applied to four periarticular knee regions, including the medial and lateral patellar borders, the suprapatellar region, and the medial tibiofemoral joint line. Participants received 10 treatment sessions over four weeks. HILT was administered in combination with a standardized exercise program.
Andere namen:
  • Fotobiomodulatie
  • GEVEST
  • MLS Laser Therapy
  • Laser Therapy
Ander: Exercise
The exercise program was performed during each treatment session and included strengthening, flexibility, and balance exercises targeting the lower extremities. Exercises included stationary cycling, hamstring and gastrocnemius stretching, straight-leg raises, knee extensions, heel raises, step-ups, and single-leg balance activities. The program was standardized for both study groups and was delivered over 10 sessions during a four-week period.
Andere namen:
  • Therapeutische oefening
  • Revalidatie oefening
  • Exercise Program
  • Physical Therapy exercise
Sham-vergelijker: Sham Laser + Exercise
Participants received sham laser treatment combined with the same standardized exercise program used in the experimental group. Sham treatment was delivered using the same laser device and treatment schedule as the active intervention but with subtherapeutic parameters designed to maintain participant blinding. The intervention consisted of 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises.
Ander: Exercise
The exercise program was performed during each treatment session and included strengthening, flexibility, and balance exercises targeting the lower extremities. Exercises included stationary cycling, hamstring and gastrocnemius stretching, straight-leg raises, knee extensions, heel raises, step-ups, and single-leg balance activities. The program was standardized for both study groups and was delivered over 10 sessions during a four-week period.
Andere namen:
  • Therapeutische oefening
  • Revalidatie oefening
  • Exercise Program
  • Physical Therapy exercise
Apparaat: Sham Laser
Sham laser treatment was delivered using the same laser device, treatment schedule, and application sites as the active intervention. Subtherapeutic parameters were used to mimic the treatment procedure while minimizing biological effects and maintaining participant blinding. Participants received 10 treatment sessions over four weeks in combination with the same standardized exercise program used in the experimental group.
Andere namen:
  • Sham Laser Therapy
  • Placebo Laser
  • Sham High Intensity Laser Therapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Tijdsspanne: Baseline and Week 4
Change in knee extensor muscle strength measured with a dynamometer. Results were expressed in Newtons (N). Higher values indicate greater muscle strength.
Baseline and Week 4

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Tijdsspanne: Baseline and Week 4
Change in pain intensity measured using the Visual Analogue Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Baseline and Week 4
Change From Baseline in WOMAC Total Score After 4 Weeks of Treatment
Tijdsspanne: Baseline and Week 4
Change in symptoms and functional status measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Higher scores indicate greater impairment.
Baseline and Week 4

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad Metropolitana de Ciencias de la Educacion

Onderzoekers

  • Hoofdonderzoeker: Ivan Patricio Silva-Satlov, Magister, Universidad Metropolitana de Ciencias de la Educacion

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 november 2023

Primaire voltooiing (Werkelijk)

26 augustus 2025

Studie voltooiing (Werkelijk)

26 augustus 2025

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 422/2023

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data underlying the results reported in publications arising from this study will be available upon reasonable request. Data that support the primary and secondary outcome analyses, including pain, functional status, and muscle strength measurements, may be shared after publication of the primary study results. Requests will be evaluated by the Principal Investigator and must include a scientifically sound research proposal. All shared data will be fully de-identified to protect participant confidentiality.

IPD-tijdsbestek voor delen

Individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

IPD-toegangscriteria voor delen

Researchers who provide a methodologically sound research proposal may request access to de-identified individual participant data and supporting documents. Requests should be directed to the Principal Investigator. Data will be shared only after review and approval of the proposed use and may require a data sharing agreement to protect participant confidentiality and ensure appropriate use of the data.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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