The efficacy of Duloxetine and exercise compared to exercise alone in patients with knee osteoarthritis: a 12-week, randomized, double-blinded, parallel trial.

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Deise Uema
Ana Beatriz Gomes
Antonio Schlesinger
Danilo Hackner
Diego Garcia Choza
Dyego Nunes
Fernando Bernoit Peña
Giovana Negrao de Figuereido
Humberto Paredes Martinez de Arredondo
Katerina Geroula
La Zhang
Maria Flavia Luiz
Mariane Rodeigues
Muneera Al-Muhannadi
Musa Mansour
Paula Regina Fortes
Pedro Giglio
Renata Obadia
Rene Diaz
Sayuri Nakane
Stefanie Hort
Talyta Almeida

Abstract

Ostheoarthritis (OA) is an irreversible disease, which affects the population worldwide, predominantly those over 60 years of age. The treatments available comprehend conservative and surgical treatment. The complications related to disease and side effects of these interventions can impact directly on patient’s quality of life, with impairment of work capacity and daily activities. Nowadays the standard therapy for OA is exercise and adjunctive medication, as needed. Important to note that opioids should be avoided in this population, limiting the theurapetical arsenal in the management of pain. Duloxetine is an effective treatment for chronic pain as it acts on central pain sensitization, neuropathic pain and also improves associated depressive or anxiety symptoms. We considered that the synergistic effect of Duloxetine and exercise on pain and mood symptoms may offer a better control as compared to current standard treatment of patients with OA. Therefore, this 12-week multicentre double blind randomized trial will evaluate the improvement in WOMAC score (frequently used in OA to assess pain and functional limitation) of patients with knee OA treated with Duloxetine + exercise vs Placebo + exercise. Secondary outcomes include impact in quality of life (i.e. EQ-5D-5L - mobility, self-care, usual activities, pain/discomfort, anxiety/depression), frequency of use a rescue drug for pain and occurrence of major depression (DSM-V).

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How to Cite
Uema, D., Gomes, A. B., Schlesinger, A., Hackner, D., Garcia Choza, D., Nunes, D., Peña, F. B., de Figuereido, G. N., Martinez de Arredondo, H. P., Geroula, K., Zhang, L., Luiz, M. F., Rodeigues, M., Al-Muhannadi, M., Mansour, M., Fortes, P. R., Giglio, P., Obadia, R., Diaz, R., Nakane, S., Hort, S., & Almeida, T. (2019). The efficacy of Duloxetine and exercise compared to exercise alone in patients with knee osteoarthritis: a 12-week, randomized, double-blinded, parallel trial. Principles and Practice of Clinical Research, 5(1), 14-20. Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/64
Section
Study Design

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