OBJECTIVE: To assess the efficacy and safety of intra-articular injections of sodium hyaluronate combined with a home exercise program (HEP) in the management of pain associated with osteoarthritis (OA) of the knee. DESIGN: Single-blinded, parallel-design, 1-year clinical study with sequential enrollment. SETTING: University-based outpatient physiatric practice. PARTICIPANTS: Sixty patients (18 men, 42 women; age >= 50 y) with moderate-to-severe pain associated with OA of the knee. INTERVENTIONS: (1) Five weekly intra-articular hyaluronate injections (5-HYL); (2) 3 weekly intra-articular hyaluronate injections (3-HYL); or (3) a combination of an HEP with 3 weekly intra-articular hyaluronate injections (3-HYL+HEP). MAIN OUTCOME MEASURES: The primary outcome measure was a 100-mm visual analog scale for pain after a 50-foot walk (15.24 m). Secondary measures included the Western Ontario and McMaster Universities Osteoarthritis Index subscales. RESULTS: The 3-HYL+HEP group had significantly faster onset of pain relief compared with the 3-HYL (p < 0.01) and 5-HYL groups (p = 0.01). All groups showed a mean symptomatic improvement from baseline (reduction in baseline pain at 3 mo was 59%, 49%, and 48% for the 3-HYL+HEP, 3-HYL, and 5-HYL groups, respectively) that was clinically and statistically significant. There were no between-group differences in the incidence or nature of adverse events. CONCLUSIONS: The combined use of hyaluronate injections with HEP should be considered for management of moderate-to-severe pain in patients with knee OA.

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