United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.
United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-017-2352-2
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发表时间：
2017-12-22
期刊：
影响因子：
2.5
通讯作者：
Rangan A
中科院分区：
文献类型：
--
作者：
Brealey S;Armstrong AL;Brooksbank A;Carr AJ;Charalambous CP;Cooper C;Corbacho B;Dias J;Donnelly I;Goodchild L;Hewitt C;Keding A;Kottam L;Lamb SE;McDaid C;Northgraves M;Richardson G;Rodgers S;Shah S;Sharp E;Spencer S;Torgerson D;Toye F;Rangan A
冻结肩（也称为粘连性关节囊炎）发生时，关节囊或球窝肩关节周围的软组织包膜，变得疤痕和收缩，使肩膀紧张，疼痛和僵硬。在工作年龄的男性中，每12人中就有1人受影响，每10名女性中就有1人受影响。虽然这种情况可以随着时间的推移而解决（通常需要1至3年），但对某些人来说，它会导致严重的症状，需要转诊到医院。我们的目的是评估两种侵入性和昂贵的手术干预的临床和成本效益，这两种手术干预通常用于国家卫生服务（NHS）的二级护理，与早期结构化物理治疗的非手术比较。我们将对500例临床诊断为冻结肩的成人患者进行随机对照试验（RCT），这些患者的X线照片排除了其他病理。将关节内类固醇注射的早期结构化物理治疗与麻醉下类固醇注射或关节镜（锁孔）囊袋松解后进行操作进行比较。两种手术干预后都将进行术后物理治疗。这些治疗将在英国各地的NHS医院进行。主要结局和终点为12个月时的牛津肩关节评分（患者自我报告的肩关节功能评估）。这也将在基线、随机化后3个月和6个月以及治疗开始当天和6个月后进行测量。次要结局包括臂肩手残疾（QuickDASH）评分、EQ-5D-5 L评分、疼痛、恢复程度和并发症。我们将采用定性方法探讨不同治疗方法对患者和医疗保健专业人员的可接受性。正在比较的三种治疗方法是NHS二级护理中最常用的，但哪种方法效果最好以及成本如何还不确定。英国FROST是一项设计严谨、动力充足的研究，旨在为成人这种常见疾病的治疗提供临床决策。国际标准随机对照试验注册，ID：ISRCTN 48804508。2014年7月25日登记。本文的在线版本（doi：10.1186/s13063-017-2352-2）包含补充材料，可供授权用户使用。
Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014. The online version of this article (doi:10.1186/s13063-017-2352-2) contains supplementary material, which is available to authorized users.
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