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| The effect of adding a large dose of shoulder strengthening to nonoperative care for subacromial impingement on shoulder disability, quality of life, sick days, and surgery rates: 1-year results from a pragmatic, double-blind randomized controlled trial (SExSI) |
| Clausen MB, Krohn LM, Rathleff MS, Bandholm T, Jensen SN, Christensen KB, Holmich P, Thorborg K |
| Orthopaedic Journal of Sports Medicine 2025 Oct;13(10):23259671251374314 |
| clinical trial |
| This trial has not yet been rated. |
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BACKGROUND: Subacromial impingement syndrome (SIS) is the most common and costly cause of shoulder pain. Recent guidelines emphasize reducing surgical interventions in favor of exercise-based care, but many patients experience suboptimal outcomes. PURPOSE: To investigate the effect of prescribing a large dose of resistance exercises in addition to nonoperative care compared with nonoperative care alone, in patients with long-standing SIS at 1-year follow-up, on the following outcomes: shoulder disability, health-related quality of life, number of days of sick leave, and surgery rates. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This study analyzed the effect at 1 year after randomization in the Strengthening Exercises in Shoulder Impingement (SExSI) trial, a pragmatic, double-blinded randomized controlled trial with a 2-group parallel design. A total of 200 participants with long-standing SIS were randomized to 16 weeks of standard nonoperative care alone (control) or standard nonoperative care plus a large dose of progressive resistance exercises targeting the shoulder (intervention). Outcomes were assessed at 1 year and included shoulder disability (using the Shoulder Pain and Disability Index (SPADI)), health-related quality of life, days of sick leave due to the shoulder disorder (reported weekly through text messages), and surgery rates. RESULTS: At 1 year, no significant differences were observed between groups for improvements in SPADI scores (mean difference 4 (95% CI -13 to 5)) or quality of life. We observed no difference in the odds of any sick leave (odds ratio 0.84 (95% CI 0.30 to 2.30)). For those reporting sick leave, the duration was 12% shorter in the intervention group (mean ratio 0.88 (95% CI 0.38 to 2.02)), but this did not constitute a significant difference. We also did not observe any difference in surgery rates between the control and intervention groups (12.1% versus 10.8%, respectively; risk difference -1.3% (95% CI -10.9% to 8.3%)). CONCLUSION: Adding a large dose of shoulder strengthening exercises to nonoperative care for 16 weeks did not significantly improve long-term outcomes in terms of shoulder disability, health-related quality of life, sick leave, or surgery rates at 1 year. This demonstrates that adding a structured, high-volume exercise program to exercise therapy may not provide further benefits in the long-term management of SIS. Registration: NCT02747251 (ClinicalTrials.gov).
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