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

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • Fotobiomodulazione
  • ELSA
  • MLS Laser Therapy
  • Laser Therapy
Altro: 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.
Altri nomi:
  • Esercizio terapeutico
  • Esercizio riabilitativo
  • Exercise Program
  • Physical Therapy exercise
Comparatore fittizio: 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.
Altro: 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.
Altri nomi:
  • Esercizio terapeutico
  • Esercizio riabilitativo
  • Exercise Program
  • Physical Therapy exercise
Dispositivo: 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.
Altri nomi:
  • Sham Laser Therapy
  • Placebo Laser
  • Sham High Intensity Laser Therapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Metropolitana de Ciencias de la Educacion

Investigatori

  • Investigatore principale: Ivan Patricio Silva-Satlov, Magister, Universidad Metropolitana de Ciencias de la Educación

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 novembre 2023

Completamento primario (Effettivo)

26 agosto 2025

Completamento dello studio (Effettivo)

26 agosto 2025

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 422/2023

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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