Effects of High-Intensity Laser Therapy Combined With Exercise in Patients With Knee Osteoarthritis (HILT-KOA)
1 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
31
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7760197
- Departamento de Kinesiología
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
Outros nomes:
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.
Outros nomes:
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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.
Outros nomes:
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Investigador principal: Ivan Patricio Silva-Satlov, Magister, Universidad Metropolitana de Ciencias de la Educacion
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de novembro de 2023
Conclusão Primária (Real)
26 de agosto de 2025
Conclusão do estudo (Real)
26 de agosto de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
5 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Artrite
- Doenças articulares
- Doenças Reumáticas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor
- Osteoartrite
- Osteoartrite, Joelho
- Doenças musculoesqueléticas
- Atividade motora
- Movimento
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Terapêutica
- Procedimentos cirúrgicos, operatórios
- Modalidades de fisioterapia
- Atendimento ao paciente
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Condicionamento físico, humano
- Fototerapia
- Técnicas de ablação
- Exercício
- Terapia de exercícios
- Treinamento de resistência
- Terapia com luz de baixo nível
- Terapia a laser
Outros números de identificação do estudo
- 422/2023
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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