肩の痛みに対するステロイド注射と運動療法の有効性に関する比較（SIX-Shoulder Study）：無作為化比較試験

Guidelines recommend a corticosteroid injection or exercise therapy for shoulder pain in primary care, but long-term comparative studies are lacking.

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.

A pragmatic randomized controlled trial.

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.

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).

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.

The Netherlands Trial Registry (NL-OMON52854).