Abstract
BACKGROUND: Neuromuscular exercise (NEXA) and celecoxib each are effective for treating knee osteoarthritis (OA), but the potential benefits of combination therapy remain unclear. The aim of this study was to investigate the effects of NEXA in addition to celecoxib compared to celecoxib alone on pain and physical function in patients with symptomatic and radiographic knee OA. METHODS: A prospective, assessor-blinded, two-arm, superiority randomised controlled trial. Sixty participants with Kellgren and Lawrence (KL) grade 2-3 symptomatic knee OA were included and randomly assigned 1:1 to undergo 12 weeks NEXA and celecoxib or to receive celecoxib 200 mg once daily alone. The primary outcomes were visual analog scale (VAS) and total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 6 months. The secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS), six-minute walk test, and Timed Up and Go (TUG) test at 3 months and 6 months. RESULTS: At 6 months, the between-group differences in the VAS score (mean difference, -10.30; 95% CI, -19.38 to -1.23; P = 0.026) and total WOMAC score (mean difference, -10.40; 95% CI, -15.54 to -5.27; P < 0.001) were statistically in favour of the NEXA and celecoxib group. There was evidence that NEXA in addition to celecoxib were superior to celecoxib alone for KOOS symptoms score (P = 0.040), KOOS activities of daily living score (P < 0.001), KOOS sport and recreation score (P = 0.014), KOOS quality of life score (P = 0.036), six-min walk test (P = 0.006), and TUG test (P = 0.001) at 6 months. The NEXA and celecoxib group achieved significantly higher proportions of patients above the minimal clinically important difference in total WOMAC score (78.6% vs. 51.9% for absolute improvement; 75% vs. 37% for relative improvement) at 6 months. CONCLUSIONS: Compared with celecoxib alone, there was a beneficial effect of NEXA in addition to celecoxib on pain and physical function in patients with symptomatic and radiographic knee OA at 6 months. TRIAL REGISTRATION: ChiCTR-IOR-14,005,414, 31/10/2014.