Objective: To compare the effectiveness of subacromial corticosteroid injection combined with timely exercise and manual therapy (injection plus exercise) or exercise and manual therapy alone (exercise only) in patients with subacromial impingement syndrome.
Design: Pragmatic randomised clinical trial.
Setting: Primary care based musculoskeletal service. Patients Adults aged 40 or over with subacromial impingement syndrome with moderate or severe shoulder pain.
Interventions: Injection plus exercise or exercise only.
Main outcome measures: Primary outcome was the difference in improvement in the total shoulder pain and disability index at 12 weeks.
Results: 232 participants were randomised (115 to injection plus exercise, 117 to exercise only). The mean age was 56 (range 40-78), 127 were women, and all had had a median of 16 weeks of shoulder pain (interquartile range 12-28). At week 12 there was no significant difference between the groups in change in total pain and disability index (mean difference between change in groups 3.26 (95% confidence interval -0.81 to 7.34), P=0.116). Improvement was significantly greater in the injection plus exercise group at week 1 (6.56, 4.30 to 8.82) and week 6 (7.37, 4.34 to 10.39) for the total pain and disability index (P<0.001), with no differences at week 24 (-2.26, -6.77 to 2.25, P=0.324).
Conclusions: In the treatment of patients with subacromial impingement syndrome, injection plus exercise and exercise only are similarly effective at 12 weeks. Trial registration ISRCT 25817033; EudraCT No 2005-003628-20.