Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland
TAYS Hatanpää/Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland.
Br J Sports Med. 2021 Jan;55(2):99-107. doi: 10.1136/bjsports-2020-102216. Epub 2020 Oct 5.
To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison).
We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry.
In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events.
ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome.
通过与诊断性关节镜检查（主要比较）、安慰剂手术干预以及非手术替代方法——运动疗法（次要比较）进行比较，评估关节镜下肩峰下减压术（ASD）的长期疗效。
我们进行了一项多中心、三组、随机、对照的优势试验。我们纳入了 210 名年龄在 35-65 岁之间、肩部撞击综合征症状持续超过 3 个月的患者。175 名参与者（83%）完成了 5 年随访。患者招募于 2005 年 2 月 1 日开始，2018 年 10 月 10 日完成了 5 年随访。两个主要结局是静息时和手臂活动时的肩部疼痛，使用视觉模拟量表（VAS）进行测量。最小有意义差异（MID）设定为 15。我们使用参与者为随机因素、基线值为协变量的混合模型重复测量方差分析，并假设具有复合对称的协方差结构。
在主要意向治疗分析（ASD 与诊断性关节镜检查）中，在 5 年时，两组之间没有超过主要结局 MID 的差异：组间差异（ASD 减去诊断性关节镜检查）在静息时为-2.0（95%CI-8.5 至 4.6；p=0.56），在手臂活动时为-8.0（-17.3 至 1.3；p=0.093）。两组之间在次要结局或不良事件方面没有超过 MID 的差异。在我们的次要比较（ASD 与运动疗法）中，组间差异（ASD 减去运动疗法）在静息时为 1.0（-5.6 至 7.6；p=0.77），在手臂活动时为-3.9（-12.8 至 5.1；p=0.40）。两组之间在次要结局或不良事件方面没有显著差异。
对于肩部撞击综合征患者，5 年时 ASD 与诊断性关节镜检查（或运动疗法）相比没有获益。
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