Kearney Rebecca S, Ellard David R, Parsons Helen, Haque Aminul, Mason James, Nwankwo Henry, Bradley Helen, Drew Stephen, Modi Chetan, Bush Howard, Torgerson David, Underwood Martin
Bristol Trials Centre, University of Bristol, Bristol, UK
Warwick Clinical Trials Unit, University of Warwick, Warwick, UK.
BMJ. 2024 Jan 17;384:e076925. doi: 10.1136/bmj-2023-076925.
To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy.
Pragmatic, multicentre, randomised controlled trial (ARTISAN).
Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management.
One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses.
The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications.
482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05).
An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy.
Current Controlled Trials ISRCTN63184243.
评估针对首次创伤性肩关节脱位成人患者增加物理治疗方案的效果，并与单次的建议、辅助材料以及自我转诊至物理治疗的选项进行比较。
实用、多中心、随机对照试验（工匠研究）。
英国41个国民健康服务信托机构的创伤研究团队对经放射学确诊为首次创伤性前肩关节脱位且接受非手术治疗的成人进行筛查。若患者双肩均脱位、存在神经血管并发症或考虑接受手术治疗，则被排除。
将接受一次建议、辅助材料以及自我转诊至物理治疗选项的患者（n = 240）与接受相同建议和辅助材料以及额外物理治疗方案的患者（n = 242）进行评估比较。分析采用意向性分析，并进行次要的符合方案分析。
主要结局为牛津肩关节不稳定评分（一种肩关节功能的单一综合测量指标），在治疗分配后6个月进行测量。次要结局包括快速残疾评定量表、EQ - 5D - 5L以及并发症。
从英国40个地点招募了482名参与者。354名（73%）参与者完成了主要结局评分（n = 180名被分配至仅接受建议组，n = 174名被分配至接受建议和物理治疗组）。参与者大多为男性（66%），平均年龄45岁。在6个月时进行的主要意向性分析调整分析中，接受建议组与接受建议和物理治疗方案组之间未发现显著差异（组间差异有利于物理治疗，差值为1.5（95%置信区间 - 0.3至3.5）），在更早的3个月和6周时间点也未发现显著差异。两组的并发症情况相似（P>0.05）。
当前额外的物理治疗方案并不优于建议、辅助材料以及自我转诊至物理治疗的选项。
当前受控试验ISRCTN63184243。
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