OBJECTIVE: To evaluate the impact of standardised consultations on patients with osteoarthritis of the knee. DESIGN: Open pragmatic cluster randomised controlled trial. SETTING: Primary care in France. PARTICIPANTS: 198 primary care rheumatologists, each of whom had to include two consecutive patients who met the American College of Rheumatology criteria for osteoarthritis of the knee. INTERVENTIONS: Standardised consultation was provided during three goal oriented visits (education on osteoarthritis and treatment management; information on physical exercises; information on weight loss) or usual care. MAIN OUTCOME MEASURES: Change in body weight and in time spent on physical exercises (Baecke index) at four months. RESULTS: 336 patients were included (154 allocated to standardised consultation and 182 to usual care). Nine patients were excluded because of lack of baseline data (standardised consultation, n=8; usual care, n=1). At four months, taking into account the clustering effect, the decrease in weight was greater in the standardised consultation group than in the usual care group (mean -1.11 (SD 2.49) kg v -0.37 (2.39) kg; P=0.007). The physical activity score was higher for the standardised consultation group than for the usual care group (mean 0.20 (0.65) v 0.04 (0.78); P=0.013). The standardised consultation and usual care groups did not differ in secondary outcomes, except for global assessment of disease activity (0-10 numeric scale: mean -1.66 (2.26) v -0.90 (2.48); P=0.003) and pain level (0-10 numeric scale: mean -1.65 (2.32) v -1.18 (2.58); P=0.04). CONCLUSIONS: A structured consultation programme for patients with osteoarthritis of the knee resulted in short term improvement in weight loss and time spent on physical activity. TRIAL REGISTRATION: Clinical trials NCT00462319.
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