Di Mascio Livio, Hamborg Thomas, Mihaylova Borislava, Kassam Jamila, Shah Bina, Stuart Beth, Griffin Xavier L
Barts Health NHS Trust, The Royal London Hospital, London, UK.
Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
Bone Jt Open. 2024 Mar 4;5(3):162-173. doi: 10.1302/2633-1462.53.BJO-2023-0114.
Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.
In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.
We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research.
We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder.
对于肩周炎患者，在社区环境中开展一项将皮质类固醇注射（CSI）与液压扩张（HD）进行对比的确定性多中心试验是否可行？在初级医疗保健中开展一项有足够效力的确定性随机对照试验（RCT），将告知临床医生和公众液压扩张是否是一种具有临床疗效且具成本效益的干预措施。在本研究中，在进行全面的RCT之前，我们提议开展一项可行性试验，以通过患者和临床医生对随机分组的意愿来评估招募和保留情况；退出、交叉和损耗率；以及从常规初级和二级医疗保健数据中收集结局数据的可行性。
在英国，国家卫生与临床优化研究所（NICE）建议在初级医疗保健环境中通过镇痛、物理治疗和关节注射对肩周炎进行及时的早期管理；大多数人无需手术即可得到治疗。目前，关节注射的类型存在差异：1）CSI，被认为可减轻关节囊炎症从而减轻疼痛；2）HD，即向肩关节内注射少量液体及类固醇，旨在拉伸肩关节囊以改善疼痛，并增加活动度。在全国范围内建立肌肉骨骼中心为肩周炎的早期有效管理提供了基础设施。这可能会降低个人和更广泛的国民医疗服务体系（NHS）的成本，或许无需转诊至二级医疗保健机构。
我们将开展一项多中心RCT，比较CSI与HD联合使用与单独使用CSI的效果。年龄在18岁及以上且临床诊断为肩周炎的患者将被随机分组并设盲，分别接受CSI与HD联合治疗或仅接受CSI治疗。可行性结局包括随机分组率（作为符合条件患者的比例）以及使用常规收集的数据进行结局评估的能力。本研究让患者和公众参与了试验设计、传播方法以及如何纳入研究服务不足的群体。
我们将通过英国骨科协会、特许物理治疗师协会、皇家放射科医师学院和皇家全科医师学院，在肌肉骨骼临床医生中传播研究结果。为确保广泛传播，除了准备孟加拉语和乌尔都语（伦敦东北部常用语言）的传播资料外，我们还将通过我们已建立的慈善机构和组织网络来传达研究结果。如果全面试验被证明可行，我们将寻求国家卫生与临床研究机构的额外资金以开展确定性RCT。这项确定性研究将为NICE的肩周炎管理指南提供参考。
