Effect of unloading brace treatment on pain and function in patients with symptomatic knee osteoarthritis: the ROTOR randomized clinical trial
2018
Thoumie, P. | Marty, M. | Avouac, B. | Pallez, A. | Vaumousse, A. | Pipet, L. P. T. | Monroche, A. | Graveleau, N. | Bonnin, A. | Ben Amor, C. | Coudeyre, E. | CHU Rothschild [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) | Assistance aux Gestes et Applications THErapeutiques (AGATHE) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut des Systèmes Intelligents et de Robotique (ISIR) ; Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS) | Sorbonne Université (SU) | Institut National de la Santé et de la Recherche Médicale (INSERM) | Nukleus | Rhumatologie ; Hôpital Henri Mondor, Assistance Publique - Hôpitaux de Paris (AP-HP) | Societe Thuasne | Euraxi Pharma | Cabinet Médical | Clinique du Sport | Unité de Nutrition Humaine (UNH) ; Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]) | Université Clermont Auvergne [2017-2020] (UCA [2017-2020]) | Service Médecine Physique et de Réadaptation [CHU Clermont-Ferrand] ; CHU Gabriel Montpied [Clermont-Ferrand] ; CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand] ; CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand] ; CHU Clermont-Ferrand-Pôle Mobilité et exercice physique [CHU Clermont-Ferrand] (MOBEX) ; CHU Gabriel Montpied [Clermont-Ferrand] ; CHU Clermont-Ferrand-CHU Clermont-Ferrand
Evidence is still inconclusive for the benefits of bracing in patients with knee osteoarthritis. To assess the effect of REBEL RELIEVER unloading knee brace in conservative treatment of knee osteoarthritis, a randomized controlled trial was conducted in 67 patients with symptomatic medial knee osteoarthritis, who randomly received 6-week treatment with either REBEL RELIVER unloading knee brace + usual care (Brace group, N = 32) or usual care alone (Control group, N = 35). Primary outcome was the global last 24h-pain relief (100-mm visual analogic scale [VAS]) at 6 weeks. Secondary endpoints included pain on motion (100-mm VAS), function (Lequesne index), safety and observance. At 6 weeks, mean [SD] last 24h-pain decreased significantly more in Brace group versus Control group (-41.35 [3.37] vs -15.37 [3.23], difference - 25.98, 95% CI - 41.64 to - 10.33, P < 0.0001). Higher mean [SD] pain on motion decrease (-51.91 [3.49] vs - 19.91 [3.34], difference - 32.01, 95% CI - 48.21 to - 15.80, P < 0.0001) and better improvement of Lequesne index score (-5.8 [0.5] vs - 2.3 [0.5], difference - 3.5, 95% CI-5.0 to - 2.0, P < 0.0001) were observed in Brace group. Safety and observance to the brace were excellent. The additive clinical benefit of wearing REBEL RELIEVER unloading knee brace was demonstrated in knee osteoarthritis patients.
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