BACKGROUND: Guidelines recommend a corticosteroid injection or exercise therapy for shoulder pain in primary care, but long-term comparative studies are lacking. OBJECTIVE: To examine the effectiveness of a corticosteroid injection versus physiotherapist-led exercise therapy over 12 months in patients with shoulder pain presenting in primary care. DESIGN: A pragmatic randomized controlled trial. METHODS: Patients with a new episode of shoulder pain were included and randomly allocated to a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. Questionnaires were administered at baseline, 6 weeks, 3, 6, 9 and 12 months. The primary outcome was pain and function measured with the Shoulder Pain and Disability Index (SPADI) over 12 months. RESULTS: 99 patients were included in the injection group and 101 in the exercise therapy group. Side effects were reported in 25% of the exercise therapy group and 7% of the injection group. At 12 months follow-up, the exercise therapy group showed a statistically significantly greater improvement of SPADI-score (mean difference 8.5, 95% CI 1.2 to 15.8) compared to the injection group. This was also seen at 6 months (mean difference 9.6, 95% CI 2.3 to 16.9) and 9 months (mean difference 7.9, 95% CI 0.4 to 15.4). The injection group showed a statistically significantly greater improvement of SPADI-score at 6 weeks (mean difference -7.7, 95% CI -14.9 to -0.6). CONCLUSION: There is an indication that treatment with exercise therapy gives statistically significant better SPADI-scores over 12 months follow-up. However, wide confidence intervals indicate uncertainty in the effect estimates. REGISTRATION: The Netherlands Trial Registry (NL-OMON52854).

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