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Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial
The BMJ ( IF 105.7 ) Pub Date : 2024-01-17 , DOI: 10.1136/bmj-2023-076925
Rebecca S Kearney , David R Ellard , Helen Parsons , Aminul Haque , James Mason , Henry Nwankwo , Helen Bradley , Stephen Drew , Chetan Modi , Howard Bush , David Torgerson , Martin Underwood

Objective 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. Design Pragmatic, multicentre, randomised controlled trial (ARTISAN). Setting and participants 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. Interventions 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. Main outcome measures 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. Results 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). Conclusions An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. Trial registration Current Controlled Trials [ISRCTN63184243.][1] All data requests should be submitted to WCTUDataAccess@warwick.ac.uk for consideration. Access to anonymised data may be granted following review. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN63184243.

中文翻译:

创伤性肩关节前脱位后的急性康复(ARTISAN):务实、多中心、随机对照试验

目的 评估与单次咨询、支持材料和自我参考物理治疗选择相比,额外物理治疗方案对首次创伤性肩关节脱位成人的效果。设计务实、多中心、随机对照试验 (ARTISAN)。环境和参与者 英国 NHS 信托基金会 41 个地点的创伤研究小组对经放射学证实首次发生外伤性肩关节前脱位的成年人进行了筛查,并进行了非手术治疗。如果患者出现双肩脱臼、有神经血管并发症或考虑进行手术治疗,则被排除在外。干预措施 根据相同的建议和支持材料以及额外的物理治疗计划(n = 242),对一次建议、支持材料和自我参考物理治疗的选择(n = 240)进行评估。分析是在意向治疗的基础上进行的,并根据方案进行二次分析。主要结果指标 主要结果是牛津肩部不稳定评分(肩部功能的单一综合指标),在治疗分配后六个月进行测量。次要结局包括 QuickDASH、EQ-5D-5L 和并发症。结果 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果评分(n=180 分配给仅建议,n=174 分配给建议和物理治疗)。参与者大多为男性 (66%),平均年龄为 45 岁。在主要意向治疗调整分析中,与建议和物理治疗计划相比,建议与物理治疗计划之间没有显着差异(支持物理治疗的组间差异为 1.5(95% 置信区间 -0.3 至 3.5))或前三个一个月和六周的时间点。两组的并发症情况相似(P>0.05)。结论 当前物理治疗的附加计划并不优于建议、支持材料和自我参考物理治疗的选择。试验注册 当前对照试验 [ISRCTN63184243.][1] 所有数据请求均应提交至 WCTUDataAccess@warwick.ac.uk 供考虑。经过审查后可能会授予对匿名数据的访问权限。[1]:/external-ref?link_type=ISRCTN&access_num=ISRCTN63184243。
更新日期:2024-01-18
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