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Physiotherapist-supervised exercises versus unsupervised home-based exercises after nonsurgically treated proximal humerus fracture: a multicenter randomized controlled trial |
Ostergaard HK, Launonen AP, Toft M, Fjalestad T, Sumrein BO, Dossing KV, Axelsen MH, Noe SS, Wagle T, Engebretsen KB, Laitinen MK, Mattila VM, Mechlenburg I |
Journal of Shoulder and Elbow Surgery 2024 May;33(5):994-1003 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Proximal humerus fracture (PHF) is a common fragility fracture in older adults and can have a substantial impact on upper limb function. Although most patients with PHF can be treated non-surgically, it is unknown whether older adults benefit from supervised exercise therapy after PHF. Therefore, the objective of this trial was to investigate whether 10 weeks of physiotherapist-supervised exercises once a week was superior to 10 weeks of non-supervised home-based exercises in older adults with a non-surgically treated displaced 2-part PHF. METHODS: This was designed as an assessor-blinded, prospective, randomized controlled trial and took place in three Nordic countries. In total, 72 patients (>= 60 years) with non-surgically treated displaced 2-part PHF were randomized to either physiotherapist-supervised exercises once a week for 10 weeks combined with daily home-based exercises were compared to 10 weeks of daily non-supervised home-based exercises. The primary outcome measure was the Disability of the Arm, Shoulder, and Hand (DASH) with a primary endpoint at 3 months. Secondary outcomes were DASH (at 12 months), Constant-Murley Score, the 15D-instrument, Visual Analog Scale, General Self-Efficacy Scale, and Pain Catastrophizing Scale, with follow-up visits after 3 and 12 months. Non-union and patient death within 3 months were counted as complications. RESULTS: The mean age of the patients in both groups was 73 years. At 3 months follow-up, the mean DASH score in the supervised group was 25.9 (SD 16.0) compared to 22.4 (18.9) in the non-supervised group. The mean between-group difference (3.5, 95% CI -5.0 to 12.5) was not clinically relevant. None of the secondary outcome measures presented any clinically relevant or statistically significant between-group differences at 3 or 12 months follow-up. One patient in the supervised group and three in the non-supervised group were diagnosed with non-union. One patient from each group died before 3 months follow-up. CONCLUSIONS: This trial provides no evidence that supervised exercises are superior to non-supervised home-based exercises in improving functional outcome or quality of life in older patients with a non-surgically treated 2-part PHF. Further, our results suggest that most older adults with a non-surgically treated 2-part PHF can perform home-based exercises without the supervision of a physiotherapist.
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