Protocol for a multicenter, randomised controlled trial of surgeon-directed home therapy vs. outpatient rehabilitation by physical therapists for reverse total shoulder arthroplasty: the SHORT trial.
June S Kennedy, Emily K Reinke, Lisa G M Friedman, Chad Cook, Brian Forsythe, Robert Gillespie, Armodios Hatzidakis, Andrew Jawa, Peter Johnston, Sameer Nagda, Gregory Nicholson, Benjamin Sears, Brent Wiesel, Grant E Garrigues, Christopher Hagen, Insup Hong, Marcella Roach, Natasha Jones, Kuhan Mahendraraj, Evan Michaelson, Jackie Bader, Libby Mauter, Sunita Mengers, Nellie Renko, John Strony, Paul Hart, Elle Steele, Amanda Naylor, Jaina Gaudette, Katherine Sprengel
{"title":"Protocol for a multicenter, randomised controlled trial of surgeon-directed home therapy vs. outpatient rehabilitation by physical therapists for reverse total shoulder arthroplasty: the SHORT trial.","authors":"June S Kennedy, Emily K Reinke, Lisa G M Friedman, Chad Cook, Brian Forsythe, Robert Gillespie, Armodios Hatzidakis, Andrew Jawa, Peter Johnston, Sameer Nagda, Gregory Nicholson, Benjamin Sears, Brent Wiesel, Grant E Garrigues, Christopher Hagen, Insup Hong, Marcella Roach, Natasha Jones, Kuhan Mahendraraj, Evan Michaelson, Jackie Bader, Libby Mauter, Sunita Mengers, Nellie Renko, John Strony, Paul Hart, Elle Steele, Amanda Naylor, Jaina Gaudette, Katherine Sprengel","doi":"10.1186/s40945-021-00121-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Reverse total shoulder arthroplasty (RTSA) has emerged as a successful surgery with expanding indications. Outcomes may be influenced by post-operative rehabilitation; however, there is a dearth of research regarding optimal rehabilitation strategy following RTSA. The primary purpose of this study is to compare patient reported and clinical outcomes after RTSA in two groups: in one group rehabilitation is directed by formal, outpatient clinic-based physical therapists (PT group) as compared to a home therapy group, in which patients are instructed in their rehabilitative exercises by surgeons at post-operative appointments (HT group). Secondary aims include comparisons of complications, cost of care and quality of life between the two groups.</p><p><strong>Methods: </strong>This randomised controlled trial has commenced at seven sites across the United States. Data is being collected on 200 subjects by clinical research assistants pre-operatively and post-operatively at 2, 6, and 12 weeks, 6 months, 1 and 2 year visits. The following variables are being assessed: American Shoulder and Elbow Surgeons (ASES), pain level using the numeric pain scale, the Single Assessment Numeric Evaluation (SANE) score, and shoulder active and passive range of motion for analysis of the primary aim. Chi square and t-tests will be used to measure differences in baseline characteristics of both groups. Repeated measures linear mixed effects modeling for measurement of differences will be used for outcomes associated with ASES and SANE and scores, and range of motion measures. Secondary aims will be analyzed for comparison of complications, cost, and quality of life assessment scores using data obtained from the PROMIS 29 v. 2, questionnaires administered at standard of care post-operative visits, and the electronic health record. Subjects will be allowed to crossover between the PT and HT groups, and analysis will include both intention-to-treat including patients who crossed over, and a second with cross-over patients removed, truncated to the time they crossed over.</p><p><strong>Discussion: </strong>RTSA is being performed with increasing frequency, and the optimal rehabilitation strategy is unclear. This study will help clarify the role of formal physical therapy with particular consideration to outcomes, cost, and complications. In addition, this study will evaluate a proposed rehabilitation strategy.</p><p><strong>Trial registration: </strong>This study is registered as NCT03719859 at ClincialTrials.gov .</p>","PeriodicalId":72290,"journal":{"name":"Archives of physiotherapy","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2021-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8662891/pdf/","citationCount":"5","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of physiotherapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40945-021-00121-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"REHABILITATION","Score":null,"Total":0}
引用次数: 5
Abstract
Background: Reverse total shoulder arthroplasty (RTSA) has emerged as a successful surgery with expanding indications. Outcomes may be influenced by post-operative rehabilitation; however, there is a dearth of research regarding optimal rehabilitation strategy following RTSA. The primary purpose of this study is to compare patient reported and clinical outcomes after RTSA in two groups: in one group rehabilitation is directed by formal, outpatient clinic-based physical therapists (PT group) as compared to a home therapy group, in which patients are instructed in their rehabilitative exercises by surgeons at post-operative appointments (HT group). Secondary aims include comparisons of complications, cost of care and quality of life between the two groups.
Methods: This randomised controlled trial has commenced at seven sites across the United States. Data is being collected on 200 subjects by clinical research assistants pre-operatively and post-operatively at 2, 6, and 12 weeks, 6 months, 1 and 2 year visits. The following variables are being assessed: American Shoulder and Elbow Surgeons (ASES), pain level using the numeric pain scale, the Single Assessment Numeric Evaluation (SANE) score, and shoulder active and passive range of motion for analysis of the primary aim. Chi square and t-tests will be used to measure differences in baseline characteristics of both groups. Repeated measures linear mixed effects modeling for measurement of differences will be used for outcomes associated with ASES and SANE and scores, and range of motion measures. Secondary aims will be analyzed for comparison of complications, cost, and quality of life assessment scores using data obtained from the PROMIS 29 v. 2, questionnaires administered at standard of care post-operative visits, and the electronic health record. Subjects will be allowed to crossover between the PT and HT groups, and analysis will include both intention-to-treat including patients who crossed over, and a second with cross-over patients removed, truncated to the time they crossed over.
Discussion: RTSA is being performed with increasing frequency, and the optimal rehabilitation strategy is unclear. This study will help clarify the role of formal physical therapy with particular consideration to outcomes, cost, and complications. In addition, this study will evaluate a proposed rehabilitation strategy.
Trial registration: This study is registered as NCT03719859 at ClincialTrials.gov .
背景:反向全肩关节置换术(RTSA)已成为一种成功的手术,适应症扩大。结果可能受术后康复的影响;然而,关于RTSA后最佳康复策略的研究还很缺乏。本研究的主要目的是比较两组RTSA后患者报告和临床结果:一组康复由正式的门诊物理治疗师(PT组)指导,而家庭治疗组,患者在术后预约时由外科医生指导他们的康复练习(HT组)。次要目的包括比较两组之间的并发症、护理费用和生活质量。方法:这项随机对照试验在美国的7个地点开始。由临床研究助理在术前和术后2周、6周和12周、6个月、1年和2年随访时收集200名受试者的数据。评估了以下变量:美国肩关节外科医生(ase),使用数字疼痛量表的疼痛程度,单一评估数字评估(SANE)评分,以及用于分析主要目标的肩部主动和被动活动范围。卡方检验和t检验将用于测量两组基线特征的差异。用于测量差异的重复测量线性混合效应模型将用于与asas和SANE相关的结果和评分,以及运动范围测量。次要目的将分析比较并发症、成本和生活质量评估得分,使用从PROMIS 29 v. 2获得的数据、在标准护理术后就诊时进行的问卷调查和电子健康记录。受试者将被允许在PT组和HT组之间进行交叉,分析将包括包括交叉患者在内的治疗意向,以及将交叉患者移除的第二组,截断到他们交叉的时间。讨论:RTSA的实施频率越来越高,最佳的康复策略尚不清楚。这项研究将有助于明确正式物理治疗的作用,特别是考虑到结果、成本和并发症。此外,本研究将评估拟议的康复策略。试验注册:本研究在ClincialTrials.gov注册为NCT03719859。