Abstract：
BACKGROUND: Rotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder pain. Currently, exercise is proposed as the first-line treatment for patients suffering from RCRSP. However, adherence to therapeutic exercise programmes can be poor in the long term in a home setting. The aim of this study is to evaluate the effects of adding video animations to a traditional paper-based exercise programme.
METHODS: A single-centre, randomised, open-labelled clinical trial will be conducted in a hospital in Spain. Adults aged between 18 and 80 years diagnosed with RCRSP who meet the eligibility criteria will be included. Patients (n=132) will be randomised into two groups, with both receiving paper-based exercises, and the experimental group will also be provided with video animations. The participants will receive seven face-to-face physical therapy sessions and will be asked to perform the exercises at home for 6 months. The primary outcome measure will be the Shoulder Pain and Disability Index, measured at baseline, 3 weeks, 3 months (primary analysis) and 6 months. Secondary outcomes will be the patient\'s pain intensity during the last week (rest, during movement and at night); expectations of improvement; satisfaction with treatment; impression of improvement; perceived usability, usefulness and satisfaction of multimedia animations; and adherence to exercises. Generalised least squares regression models with an autoregressive-moving average lag one correlation structure will be implemented, with an intention-to-treat analysis.
BACKGROUND: This study has been approved by the ethics committee of Hospital Universitario Fundación Alcorcón (Madrid, Spain), reference number CI18/16. All participants will sign an informed consent. The results will be published in a peer-reviewed scientific journal.
BACKGROUND: ClinicalTrials.gov, NCT05770908.
METHODS: A single-centre, randomised, open-labelled clinical trial will be conducted in a hospital in Spain. Adults aged between 18 and 80 years diagnosed with RCRSP who meet the eligibility criteria will be included. Patients (n=132) will be randomised into two groups, with both receiving paper-based exercises, and the experimental group will also be provided with video animations. The participants will receive seven face-to-face physical therapy sessions and will be asked to perform the exercises at home for 6 months. The primary outcome measure will be the Shoulder Pain and Disability Index, measured at baseline, 3 weeks, 3 months (primary analysis) and 6 months. Secondary outcomes will be the patient\'s pain intensity during the last week (rest, during movement and at night); expectations of improvement; satisfaction with treatment; impression of improvement; perceived usability, usefulness and satisfaction of multimedia animations; and adherence to exercises. Generalised least squares regression models with an autoregressive-moving average lag one correlation structure will be implemented, with an intention-to-treat analysis.
BACKGROUND: This study has been approved by the ethics committee of Hospital Universitario Fundación Alcorcón (Madrid, Spain), reference number CI18/16. All participants will sign an informed consent. The results will be published in a peer-reviewed scientific journal.
BACKGROUND: ClinicalTrials.gov, NCT05770908.
摘要：
背景：肩袖相关性肩痛（RCRSP）是肩痛的最常见原因。目前,建议将运动作为RCRSP患者的一线治疗方法。然而,在家庭环境中，长期坚持治疗性锻炼计划可能很差。这项研究的目的是评估在传统的纸质运动计划中添加视频动画的效果。
方法：单中心，随机化，开放标签的临床试验将在西班牙的一家医院进行.符合资格标准的18至80岁被诊断患有RCRSP的成年人将被包括在内。患者（n=132）将被随机分为两组，双方都接受纸质练习，实验组还将提供视频动画。参与者将接受7次面对面的物理治疗，并将被要求在家中进行6个月的练习。主要结果指标将是肩痛和残疾指数，在基线测量，3周,3个月（主要分析）和6个月。次要结果将是患者上周的疼痛强度(休息，在运动中和夜间)；改善的期望；对治疗的满意度；改善的印象；感知可用性，多媒体动画的有用性和满意度；以及对练习的坚持。将实现具有自回归移动平均滞后一个相关结构的广义最小二乘回归模型，进行意向治疗分析。
背景：本研究已获得Alcorcón医院大学伦理委员会的批准（马德里，西班牙),参考编号CI18/16。所有参与者将签署知情同意书。研究结果将发表在同行评审的科学杂志上。
背景：ClinicalTrials.gov，NCT05770908。
方法：单中心，随机化，开放标签的临床试验将在西班牙的一家医院进行.符合资格标准的18至80岁被诊断患有RCRSP的成年人将被包括在内。患者（n=132）将被随机分为两组，双方都接受纸质练习，实验组还将提供视频动画。参与者将接受7次面对面的物理治疗，并将被要求在家中进行6个月的练习。主要结果指标将是肩痛和残疾指数，在基线测量，3周,3个月（主要分析）和6个月。次要结果将是患者上周的疼痛强度(休息，在运动中和夜间)；改善的期望；对治疗的满意度；改善的印象；感知可用性，多媒体动画的有用性和满意度；以及对练习的坚持。将实现具有自回归移动平均滞后一个相关结构的广义最小二乘回归模型，进行意向治疗分析。
背景：本研究已获得Alcorcón医院大学伦理委员会的批准（马德里，西班牙),参考编号CI18/16。所有参与者将签署知情同意书。研究结果将发表在同行评审的科学杂志上。
背景：ClinicalTrials.gov，NCT05770908。
