Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
29 de janeiro de 2020 atualizado por: Cid André Fidelis de Paula Gomes, University of Nove de Julho
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world.
The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA.
To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20).
12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus.
For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group.
A significance level of 5% will be adopted.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
60
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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São Paulo, Brasil, 01504-001
- University of Nove de Julho
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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
40 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- knee pain to at least six months and minimum of 4 points in pain scale
- diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
Exclusion Criteria:
- Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- knee trauma;
- Cognitive impairment;
- Psychological disorder;
- Neurological disorder (sensory or motor);
- Cancer;
- Diabetes any acute adverse health condition;
- Signs of hip OA;
- Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
- Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
- If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Exercises with blood flow restriction
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
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Experimental: Exercises with blood flow restriction + photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
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Comparador de Placebo: Blood flow restriction exercises + placebo photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Placebo photobiomodulation - photobiomodulation device turned off.
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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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Functional pain
Prazo: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Stiffness
Prazo: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Physical functional
Prazo: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Intensity of pain
Prazo: Change from Baseline in The Numerical rating pain scale at 12 weeks
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The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
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Change from Baseline in The Numerical rating pain scale at 12 weeks
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Functional capacity for sitting and standing
Prazo: Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
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sitting-rising test
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Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
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Level of pressure pain
Prazo: Change from Baseline in ThePressure Pain Threshold at 12 weeks
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Pressure Pain Threshold in the knee with algometer dynamometer.
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Change from Baseline in ThePressure Pain Threshold at 12 weeks
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Muscle skin temperature
Prazo: Change from Baseline in the muscle skin temperature at 12 weeks
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Infrared thermography, thermal imaging.
Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
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Change from Baseline in the muscle skin temperature at 12 weeks
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Maximum voluntary isometric contraction
Prazo: Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
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A portable dynamometer will be used to assess muscle contraction.
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Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
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Colaboradores e Investigadores
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Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Antecipado)
1 de novembro de 2020
Conclusão Primária (Antecipado)
1 de novembro de 2020
Conclusão do estudo (Antecipado)
1 de dezembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
27 de janeiro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de janeiro de 2020
Primeira postagem (Real)
30 de janeiro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de janeiro de 2020
Última verificação
1 de janeiro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20123719.1.0000.5511
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Indeciso
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