Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: a randomized controlled trial.

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 2 × 2 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 < .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 vs placebo injection (83% vs 96%, respectively; relative risk [RR], 0.86 [99% CI, 0.75-0.99]; P = .01) and greater 1-year recurrence (54% vs 12%; RR, 0.23 [99% CI, 0.10-0.51]; P < .001). The physiotherapy and no physiotherapy groups did not differ on 1-year ratings of complete recovery or much improvement (91% vs 88%, respectively; RR, 1.04 [99% CI, 0.90-1.19]; P = .56) or recurrence (29% vs 38%; RR, 1.31 [99% CI, 0.73-2.35]; P = .25). Similar patterns were found at 26 weeks, with lower complete recovery or much improvement after corticosteroid injection vs placebo injection (55% vs 85%, respectively; RR, 0.79 [99% CI, 0.62-0.99]; P < .001) and no difference between the physiotherapy and no physiotherapy groups (71% vs 69%, respectively; RR, 1.22 [99% CI, 0.97-1.53]; P = .84). At 4 weeks, there was a significant interaction between corticosteroid injection and physiotherapy (P = .01), whereby patients receiving the placebo injection plus physiotherapy had greater complete recovery or much improvement vs no physiotherapy (39% vs 10%, respectively; RR, 4.00 [99% CI, 1.07-15.00]; P = .004). However, there was no difference between patients receiving the corticosteroid injection plus physiotherapy vs corticosteroid alone (68% vs 71%, respectively; RR, 0.95 [99% CI, 0.65-1.38]; P = .57).

CONCLUSION AND RELEVANCE: Among patients with chronic unilateral lateral epicondylalgia, the use of corticosteroid injection vs 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.