Effects of High-Intensity Laser Therapy Combined With Exercise in Patients With Knee Osteoarthritis (HILT-KOA)
1 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
31
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chili, 7760197
- Departamento de Kinesiología
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
Autres noms:
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.
Autres noms:
|
|
Comparateur factice: 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.
|
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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Délai: 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
|
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Change From Baseline in WOMAC Total Score After 4 Weeks of Treatment
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ivan Patricio Silva-Satlov, Magister, Universidad Metropolitana de Ciencias de la Educacion
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Song HJ, Seo HJ, Kim D. Effectiveness of high-intensity laser therapy in the management of patients with knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. J Back Musculoskelet Rehabil. 2020;33(6):875-884. doi: 10.3233/BMR-191738.
- Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.
- Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.
- Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
29 novembre 2023
Achèvement primaire (Réel)
26 août 2025
Achèvement de l'étude (Réel)
26 août 2025
Dates d'inscription aux études
Première soumission
1 juin 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
5 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Arthrite
- Maladies articulaires
- Maladies rhumatismales
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- La douleur
- Arthrose
- Arthrose, Genou
- Maladies musculo-squelettiques
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Thérapeutique
- Procédures chirurgicales, opératoires
- Modalités de physiothérapie
- Soins aux patients
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Conditionnement physique, humain
- Photothérapie
- Techniques d'ablation
- Exercice
- Thérapie d'exercice
- Formation en résistance
- Thérapie lumineuse de bas niveau
- Thérapie au laser
Autres numéros d'identification d'étude
- 422/2023
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .