Effects of High-Intensity Laser Therapy Combined With Exercise in Patients With Knee Osteoarthritis (HILT-KOA)
1 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7760197
- Departamento de Kinesiología
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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.
Otros nombres:
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Comparador falso: 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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Periodo de tiempo: Baseline and Week 4
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Change in knee extensor muscle strength measured with a dynamometer.
Results were expressed in Newtons (N).
Higher values indicate greater muscle strength.
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Baseline and Week 4
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Periodo de tiempo: Baseline and Week 4
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Change in pain intensity measured using the Visual Analogue Scale (VAS).
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
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Baseline and Week 4
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Change From Baseline in WOMAC Total Score After 4 Weeks of Treatment
Periodo de tiempo: Baseline and Week 4
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Change in symptoms and functional status measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Higher scores indicate greater impairment.
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Baseline and Week 4
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Ivan Patricio Silva-Satlov, Magister, Universidad Metropolitana de Ciencias de la Educacion
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de noviembre de 2023
Finalización primaria (Actual)
26 de agosto de 2025
Finalización del estudio (Actual)
26 de agosto de 2025
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor
- Osteoartritis
- Artrosis, Rodilla
- Enfermedades musculoesqueléticas
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Modalidades de fisioterapia
- Atención al paciente
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Fototerapia
- Técnicas de ablación
- Ejercicio
- Terapia de ejercicio
- Entrenamiento de resistencia
- Terapia de luz de bajo nivel
- Terapia con láser
Otros números de identificación del estudio
- 422/2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .