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BACKGROUND AND OBJECTIVES: Osteoarthritis (OA) is the most common arthropathy and one of the major causes of chronic pain in the elderly population, which may lead to major functional incapacity of these individuals. Aiming at treating pain of elderly patients with knee OA, we have used lysine clonixinate (LC) and have evaluated its effectiveness METHOD: Randomized, double-blind, placebo-controlled clinical trial with 109 elderly patients with knee OA-related pain. Participants were distributed in two groups: Group LC and Group P (placebo), who received tablets to be used three times a day for 30 days. Evaluations were performed initially, 15 days after and at study completion, as to pain intensity at rest, at initial movement, ambulation and joint compression; and the need for additional analgesia, morning stiffness; pain-related functional incapacity, adherence, tolerability and global treatment evaluation. RESULTS: LC has significantly decreased pain at initial movement and ambulation already in the first 15 days, with 30% decrease in protokinetic pain and 31.6% in ambulation, but best results were seen after 30 days, when reductions were 42.3% and 45.5%, respectively. Additional analgesia was significantly lower with LC: 2.6% and 9.5% for groups LC and P, respectively. There were no differences between groups in morning stiffness and functional incapacity. There has been major adherence and tolerability. Global evaluation was favorable to LC, being excellent or good for 50% of patients. CONCLUSION: Lysine clonixinate was effective to treat knee OA-related pain in elderly people.JUSTIFICATIVA E OBJETIVOS: A osteoartrose (OA) é a artropatia mais comum e uma das principais causas de dor crônica na população idosa, podendo levar a grande incapacidade funcional nestes indivíduos. Objetivando o tratamento da dor em idosos com OA de joelho utilizou-se o clonixinato de lisina (CL) e avaliou-se a sua efetividade. MÉTODO: Estudo clínico e duplamente encoberto, aleatório e placebo controlado com 109 idosos com dor associada à OA de joelho. Os participantes foram divididos em dois grupos: Grupo CL e P (placebo) que receberam comprimidos para uso três vezes ao dia por 30 dias. Realizadas avaliações iniciais, após 15 dias e ao final do estudo, quanto à intensidade de dor em repouso, ao movimento inicial, à deambulação e à compressão articular; necessidade de analgesia complementar, rigidez matinal; incapacidade funcional associada à dor, aderência, tolerabilidade e avaliação global do tratamento. RESULTADOS: O CL reduziu significantemente a dor ao início do movimento e à deambulação já nos primeiros 15 dias, redução de 30% da dor protocinética e de 31,6% à deambulação, mas os melhores resultados ocorreram com 30 dias, quando as reduções foram de 42,3% e 45,5%, protocinética e à deambulação, respectivamente. A analgesia complementar foi significantemente menor com o CL: 2,6% e 9,5%, grupos CL e P, respectivamente. Não ocorreram diferenças entre os grupos para rigidez matinal e incapacidade funcional. Houve grande aderência e tolerabilidade. A avaliação global foi favorável para o CL, sendo excelente ou boa em 50%. CONCLUSÃO: O clonixinato de lisina foi efetivo no tratamento da dor associada à osteoartrite de joelho em idosos

Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate