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

2024-01-20 来源:BMJ

本文由小咖机器人翻译整理

期刊来源:BMJ

原文链接:https://doi.org/10.1136/bmj-2023-076925

摘要内容如下:

客观

评估在首次创伤性肩关节脱位的成人中增加物理治疗计划的效果,并与单次建议、支持材料和自我咨询物理治疗的选择进行比较。

设计

实用、多中心、随机对照试验(Artisan)。

设置和参与者

41个英国国民健康服务(NHS)信托机构的创伤研究小组对首次出现创伤性肩关节前脱位的成年人进行了筛查,并通过放射学证实,采用非手术治疗。排除双肩脱位、神经血管并发症或考虑手术治疗的患者。

干预措施

根据相同的建议和辅助材料以及额外的物理治疗计划(n=242),对一次会议的建议、辅助材料和自我推荐物理治疗的选择(n=240)进行评估。分析是在意向性治疗的基础上进行的,并进行了次要的符合方案分析。

主要结果指标

主要结果是牛津肩关节不稳定评分(肩关节功能的单一综合测量),在治疗分配后6个月进行测量。次要转归包括QuickDash、EQ-5D-5L和并发症。

结果

从英国的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仅分配给建议,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。在六个月的主要意向治疗调整分析中,建议与建议和物理治疗方案之间没有显著差异(两组之间的差异有利于物理治疗1.5(95%置信区间-0.3至3.5)),在更早的三个月和六周时间点也没有显著差异。两组的并发症情况相似(P>0.05)。

结论

当前物理治疗的额外方案并不优于建议、辅助材料和自我参考物理治疗的选择。

试用注册

目前的对照试验是RCTN63184243。

英文原文如下:

Abstracts

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.

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