Abstract
BACKGROUND: Exercise is the first-line treatment for knee osteoarthritis (KOA). Cryotherapy is used to control pain and inflammation, but robust evidence on its benefits is lacking. OBJECTIVE: Analyze the additional effects of cryotherapy, when associated with an exercise protocol, on pain, function, and quality of life in people with KOA. METHODS: A randomized controlled trial with sham and control groups, concealed allocation, blinded assessors, and intention-to-treat analysis. Individuals (n = 120) aged from 40 to 75, with knee pain ≥ 4 cm on 10 cm visual analog scale, and radiographic diagnosis of grade 2 or 3 (Kellgren and Lawrence) were included and divided into 3 groups (n = 40 per group): Exercise; Exercise + Cryotherapy; Exercise + Sham Cryotherapy Treatment was delivered 3 times per week for 8 weeks (24 sessions). Primary outcome was pain intensity (Visual Analog Scale). Secondary outcomes were physical function [Western Ontario and McMaster Universities (WOMAC)] and functional tests: 30-second sit-to-stand test, stair climbing test, 40-meter fast walking test, and quality of life [36-item Short Form Health Survey (SF-36)]. RESULTS: At post-intervention, for pain at rest, there were no between-group differences: Exercise vs. Exercise + Cryotherapy (mean difference, MD = -0.46 [confidence interval, 95 % CI: -1.97, 1.05]), Exercise vs. Exercise + Sham (MD = -1.27 [95 % CI: -2.78, 0.23]), Exercise + Cryotherapy vs. Exercise + Sham (MD = -0.82 [95 % CI: -2.32, 0.69]). At follow-up period, the results also did not show between-group differences (p > 0.05). CONCLUSION: Results showed the beneficial effects of exercise in the treatment of KOA, without additional effects of cryotherapy.