Effect of unloading brace treatment on pain and function in patients with symptomatic knee osteoarthritis: the ROTOR randomized clinical trial

摘要

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.