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

• Published in: Scientific reports Vol. 8; no. 1; pp. 10519 - 9
• Main Authors: Thoumie, Philippe, Marty, Marc, Avouac, Bernard, Pallez, Adeline, Vaumousse, Arnaud, Pipet, Linh Pham Thi, Monroche, André, Graveleau, Nicolas, Bonnin, Armand, Amor, Cyrine Ben, Coudeyre, Emmanuel
• Format: Journal Article
• Language: English
• Published: England Nature Publishing Group 12.07.2018; Nature Publishing Group UK
• Subjects: Arthritis; Clinical trials; Human health and pathology; Knee; Life Sciences; Orthopedic apparatus; Osteoarthritis; Pain; Patients; Unloading
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-018-28782-3

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.