IMPORTANCE: Corticosteroid injection and physiotherapy, common treatments for lateral epicondylalgia, are frequently combined in clinical practice. However, evidence on their combined efficacy is lacking. OBJECTIVE: To investigate the effectiveness of corticosteroid injection, multimodal physiotherapy, or both in patients with unilateral lateral epicondylalgia. DESIGN, SETTING, AND PATIENTS: A 2x2 factorial, randomized, injection-blinded, placebo-controlled trial was conducted at a single university research center and 16 primary care settings in Brisbane, Australia. A total of 165 patients aged 18 years or older with unilateral lateral epicondylalgia of longer than 6 weeks' duration were enrolled between July 2008 and May 2010; 1-year follow-up was completed in May 2011. INTERVENTIONS: Corticosteroid injection (n = 43), placebo injection (n = 41), corticosteroid injection plus physiotherapy (n = 40), or placebo injection plus physiotherapy (n = 41). MAIN OUTCOME MEASURES: The 2 primary outcomes were 1-year global rating of change scores for complete recovery or much improvement and 1-year recurrence (defined as complete recovery or much improvement at 4 or 8 weeks, but not later) analyzed on an intention-to-treat basis (p < 0.01). Secondary outcomes included complete recovery or much improvement at 4 and 26 weeks. RESULTS: Corticosteroid injection resulted in lower complete recovery or much improvement at 1 year versus placebo injection (83% versus 96%, respectively; relative risk (RR), 0.86 (99% CI 0.75 to 0.99); p = 0.01) and greater 1-year recurrence (54% versus 12%; RR, 0.23 (99% CI 0.10 to 0.51); p < 0.001). The physiotherapy and no physiotherapy groups did not differ on 1-year ratings of complete recovery or much improvement (91% versus 88%, respectively; RR 1.04 (99% CI 0.90 to 1.19); p = 0.56) or recurrence (29% versus 38%; RR 1.31 (99% CI 0.73 to 2.35); p = 0.25). Similar patterns were found at 26 weeks, with lower complete recovery or much improvement after corticosteroid injection versus placebo injection (55% versus 85%, respectively; RR 0.79 (99% CI 0.62 to 0.99); p < 0.001) and no difference between the physiotherapy and no physiotherapy groups (71% versus 69%, respectively; RR 1.22 (99% CI 0.97 to 1.53); p = 0.84). At 4 weeks, there was a significant interaction between corticosteroid injection and physiotherapy (p = 0.01), whereby patients receiving the placebo injection plus physiotherapy had greater complete recovery or much improvement versus no physiotherapy (39% versus 10%, respectively; RR 4.00 (99% CI 1.07 to 15.00); p = 0.004). However, there was no difference between patients receiving the corticosteroid injection plus physiotherapy versus corticosteroid alone (68% versus 71%, respectively; RR 0.95 (99% CI 0.65 to 1.38); p = 0.57). CONCLUSION AND RELEVANCE: Among patients with chronic unilateral lateral epicondylalgia, the use of corticosteroid injection versus placebo injection resulted in worse clinical outcomes after 1 year, and physiotherapy did not result in any significant differences. TRIAL REGISTRATION: anzctr.org identifier ACTRN12609000051246.

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