Prosthesis versus exercise for rotator cuff tear arthropathy - protocol of a randomised controlled trial.

IF 1.2 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL
Josefine Beck Larsen, Theis Muncholm Thillemann, Antti P Launonen, Helle Kvistgaard Østergaard, Thomas Falstie-Jensen, Aleksi Reito, Steen Lund Jensen, Inger Mechlenburg
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引用次数: 0

Abstract

Introduction: Reverse total shoulder arthroplasty is a well-established treatment for patients with rotator cuff tear arthropathy. The outcome after reverse total shoulder arthroplasty has been investigated in several studies and national registries. However, the treatment has not been compared to non-surgical treatment. The primary aim of this trial is to investigate whether reverse total shoulder arthroplasty is superior to exercise in patients with rotator cuff tear arthropathy who are eligible for reverse total shoulder arthroplasty.

Methods: In this Nordic multicentre, randomised, controlled clinical trial, 102 patients with rotator cuff tear arthropathy who are eligible for reverse total shoulder arthroplasty will be allocated (1:1) to either reverse total shoulder arthroplasty followed by usual care or to an exercise intervention. The exercise intervention comprises 12 weeks of exercise with one weekly physiotherapist-supervised session and two home-based exercises. The primary outcome is the total Western Ontario Osteoarthritis of the Shoulder index score at a 12-month follow-up.

Conclusions: The ongoing randomised controlled trial will provide insights into treatment decisions for patients with rotator cuff tear arthropathy.

Funding: This study is funded by Aarhus University, the Health Research Foundation of the Central Denmark Region, the Danish Rheumatism Association, the Association of Danish Physiotherapists, the Health Foundation (Helsefonden), the Hartmann's Foundation and the Emil Hertz Foundation in Denmark.

Trial registration:

Clinicaltrials: gov ID: NCT04864158.

假体与运动治疗肩袖撕裂性关节病-一项随机对照试验方案。
简介:反向全肩关节置换术是一种完善的治疗肩袖撕裂性关节病的方法。反向全肩关节置换术后的结果已经在几个研究和国家登记处进行了调查。然而,这种治疗方法尚未与非手术治疗方法进行比较。本试验的主要目的是研究肩袖撕裂性关节病患者逆行全肩关节置换术是否优于运动,这些患者适合逆行全肩关节置换术。方法:在这项北欧多中心、随机、对照临床试验中,102例符合逆行全肩关节置换术条件的肩袖撕裂性关节病患者将按1:1的比例被分配到逆行全肩关节置换术后的常规护理组或运动干预组。运动干预包括12周的运动,每周一次由物理治疗师监督的运动和两次以家庭为基础的运动。主要结局是在12个月的随访中,西部安大略省肩关节骨关节炎指数的总得分。结论:正在进行的随机对照试验将为肩袖撕裂性关节病患者的治疗决策提供见解。资助:本研究由奥胡斯大学、丹麦中部地区健康研究基金会、丹麦风湿病协会、丹麦物理治疗师协会、丹麦健康基金会(Helsefonden)、Hartmann基金会和Emil Hertz基金会资助。试验注册:Clinicaltrials: gov ID: NCT04864158。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Danish medical journal
Danish medical journal MEDICINE, GENERAL & INTERNAL-
CiteScore
2.30
自引率
6.20%
发文量
78
审稿时长
3-8 weeks
期刊介绍: The Danish Medical Journal (DMJ) is a general medical journal. The journal publish original research in English – conducted in or in relation to the Danish health-care system. When writing for the Danish Medical Journal please remember target audience which is the general reader. This means that the research area should be relevant to many readers and the paper should be presented in a way that most readers will understand the content. DMJ will publish the following articles: • Original articles • Protocol articles from large randomized clinical trials • Systematic reviews and meta-analyses • PhD theses from Danish faculties of health sciences • DMSc theses from Danish faculties of health sciences.
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