Terapia de ondas de choque focal para osteoartrose de joelho: um ensaio clínico randomizado duplo-cego
DOI:
https://doi.org/10.5935/0104-7795.20170033Palavras-chave:
Ondas de Choque de Alta Energia, Osteoartrite do Joelho, Avaliação da DeficiênciaResumo
Objetivo: Avaliar eficácia da terapia de ondas de choque focal (f-ESWT) comparada ao placebo para dor e incapacidade em pacientes com osteoartrose de joelho (OA). Métodos: Ensaio clínico randomizado, duplo-cego, placebo controlado, pacientes com OA primária de joelhos realizaram exercícios (alongamentos de isquiotibiais e fortalecimento de quadríceps) e randomizados em f-ESWT ou placebo. Todos os pacientes foram submetidos a 4 sessões semanais de 7.000 pulsos, e no grupo f-ESWT a energia foi de até 0.15mJ/mm2. O desfecho primário foi a escala analógica visual (VAS) para dor em 1 mês. Os desfechos secundários foram WOMAC, TUG, Lequesne e índice de resposta OMERACT-OARSI em 1 e 3 meses; bem como VAS aos 3 meses e eventos adversos (EAs). O teste de Mann-Whitney U e o teste exato Fisher foram utilizados com alfa = 5% e poder = 80% em uma análise de intenção de tratar. Os desfechos contínuos foram relatados como média ± desvio padrão. Resultados: 18 pacientes (9 em cada grupo), idade de 60.6±8.7 com 33.3% homens. Não houve diferença significativa entre grupos em qualquer variável. F-ESWT não foi superior ao placebo em 1 mês: VAS = -2,97 ± 3,18 e -2,68 ± 2,33 cm, respectivamente, p = 0,96. Somente o TUG no 1º mês foi significativo: 9.09 ± 2.30 e 11.01 ± 2.85 seg, p = 0.01. Conclusão: f-ESWT não foi superior ao placebo para osteoartrose de joelhos. Este estudo foi insuficiente para detectar diferenças. Novos estudos devem usar WOMAC A (subescala dor) como desfecho primário e recrutar 92 pacientes.
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