Research Group MOVANT, Department of Rehabilitation Sciences and Physiotherapy, University of Antwerp, Wilrijk, Belgium.
MORE Foundation, Antwerp Orthopedic Center, Algemeen Ziekenhuis Monica, Deurne, Belgium.
JMIR Res Protoc. 2024 Nov 18;13:e56522. doi: 10.2196/56522.
There is an increasing need for evidence-based postoperative rehabilitation strategies to optimize patient outcome. Knowledge of potential prognostic factors could steer the development of rehabilitation protocols and could result in better treatment outcomes and higher patient satisfaction.
This study aimed to investigate which potential prognostic factors predict baseline shoulder pain and function and its evolution in the first 2 years following surgery, in patients with total shoulder arthroplasty. The secondary objective is to investigate which potential prognostic factors predict baseline quality of life and its evolution in the first two years following surgery.
To reach the aims of this project, a prospective longitudinal study, running from January 2020 to March 2025, will be carried out with a follow-up of 48 months. Patients will be randomized based on sling wear. We will study factors such as shoulder function, patient expectations, psychosocial factors, lifestyle factors, sling wear, soft tissue integrity, and physiotherapy treatment. Test moments will take place preoperatively, at 6 weeks, 12 weeks, 6 months, 12 months, and 24 months. Descriptive statistics will be used to describe the patient population characteristics. Based on literature review, expert opinion, and univariate analyses, potential prognostic factors will be chosen as covariates. A mixed regression model for repeated measures will be used to assess both the evolution of the Shoulder Pain and Disability Index within persons from baseline over time and the differences in evolution between participants. Correlation analyses will be used to investigate associations between the other outcome measures such as the Constant and Murley Score, shoulder range of motion, shoulder muscle strength, and proprioception, and the primary outcome measure, the Shoulder Pain and Disability Index score. Potential prognostic factors not included in the model will be presented in a descriptive manner.
Data collection started in January 2020. In April 2023 the sample size was reached. Data collection will end in April 2025. Analyses will follow when data collection is completed.
Knowledge of potential prognostic factors will have implications toward better rehabilitation strategies of patients after total shoulder arthroplasty.
ClinicalTrials.gov NCT04258267; https://clinicaltrials.gov/study/NCT04258267.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56522.
为了优化患者的预后，需要更多基于证据的术后康复策略。了解潜在的预后因素可以指导康复方案的制定，并可能带来更好的治疗效果和更高的患者满意度。
本研究旨在探讨哪些潜在的预后因素可以预测全肩关节置换术后 2 年内的基线肩部疼痛和功能及其变化。次要目的是探讨哪些潜在的预后因素可以预测全肩关节置换术后 2 年内的基线生活质量及其变化。
为了实现本项目的目标，将开展一项前瞻性纵向研究，时间为 2020 年 1 月至 2025 年 3 月，随访时间为 48 个月。患者将根据吊带的佩戴情况进行随机分组。我们将研究肩部功能、患者预期、心理社会因素、生活方式因素、吊带佩戴、软组织完整性和物理治疗等因素。测试时间将在术前、6 周、12 周、6 个月、12 个月和 24 个月进行。将使用描述性统计方法描述患者人群的特征。基于文献回顾、专家意见和单变量分析，选择潜在的预后因素作为协变量。混合重复测量回归模型将用于评估个体从基线开始随时间推移的肩部疼痛和残疾指数的变化，以及参与者之间的变化差异。相关性分析将用于研究其他结局测量（如 Constant 和 Murley 评分、肩部活动范围、肩部肌肉力量和本体感觉）与主要结局测量（肩部疼痛和残疾指数评分）之间的关系。未包含在模型中的潜在预后因素将以描述性方式呈现。
数据收集于 2020 年 1 月开始。2023 年 4 月达到样本量。数据收集将于 2025 年 4 月结束。完成数据收集后将进行分析。
了解潜在的预后因素将对全肩关节置换术后患者的康复策略产生影响。
ClinicalTrials.gov NCT04258267；https://clinicaltrials.gov/study/NCT04258267。
国际注册报告标识符（IRRID）：DERR1-10.2196/56522。
