Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN, Quebec, Canada.
Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec, Canada.
BMJ Open. 2017 Sep 24;7(9):e017951. doi: 10.1136/bmjopen-2017-017951.
Rotator cuff tendinopathy (RCTe) is the most frequent cause of shoulder pain, resulting in considerable losses to society and public resources. Muscle imbalance and inadequate sensorimotor control are deficits often associated with RCTe. Kinesiotaping (KT) is widely used by clinicians for rehabilitation of RCTe. While previous studies have examined the immediate effects of KT on shoulder injuries or the effects of KT as an isolated method of treatment, no published study has addressed its mid-term and long-term effects when combined with a rehabilitation programme for patients with RCTe. The primary objective of this randomised controlled trial (RCT) will be to assess the efficacy of therapeutic KT, added to a rehabilitation programme, in reducing pain and disabilities in individuals with RCTe. Secondary objectives will look at the effects of KT on the underlying factors involved in shoulder control, such as muscular activity, acromiohumeral distance (AHD) and range of motion (ROM).
A single-blind RCT will be conducted. Fifty-two participants, randomly allocated to one of two groups (KT or no-KT), will take part in a 6-week rehabilitation programme. The KT group will receive KT added to the rehabilitation programme, whereas the no-KT group will receive only the rehabilitation programme. Measurements will be taken at baseline, week 3, week 6, week 12 and 6 months. Primary outcomes will be symptoms and functional limitations assessed by the Disabilities of the Arm, Shoulder and Hand questionnaire. Secondary outcomes will include shoulder ROM, AHD at rest and at 60° of abduction, and muscle activation during arm elevation. The added effects of KT will be assessed through a two-way analysis of variance for repeated measures.
Ethics approval was obtained from the Ethics Committee of Quebec Rehabilitation Institute of the Centre Integrated University Health and Social Services. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.
Protocol was registered at ClinicalTrials.gov (NCT02881021) on 25 August 2016. The WHO Trial Registration Data Set can also be found as an online supplementary file.
肩袖肌腱病(RCTe)是肩部疼痛最常见的原因,给社会和公共资源造成了巨大损失。肌肉失衡和感觉运动控制不足是与 RCTe 相关的常见缺陷。运动贴扎(KT)被临床医生广泛用于 RCTe 的康复。虽然之前的研究已经检查了 KT 对肩部损伤的即时影响,或者 KT 作为一种孤立的治疗方法的效果,但没有发表的研究涉及当 KT 与 RCTe 患者的康复计划结合使用时的中期和长期效果。这项随机对照试验(RCT)的主要目的将是评估治疗性 KT 对减轻 RCTe 患者疼痛和残疾的疗效。次要目标将着眼于 KT 对肩部控制相关因素的影响,如肌肉活动、肩峰肱骨关节距离(AHD)和运动范围(ROM)。
将进行一项单盲 RCT。52 名参与者随机分配到两组(KT 组或非-KT 组)之一,将参加为期 6 周的康复计划。KT 组将接受 KT 加康复计划,而非-KT 组仅接受康复计划。测量将在基线、第 3 周、第 6 周、第 12 周和 6 个月进行。主要结果将是由手臂、肩部和手残疾问卷评估的症状和功能限制。次要结果将包括肩部 ROM、休息时和 60°外展时的 AHD 以及手臂抬高时的肌肉激活。KT 的附加效果将通过重复测量的双向方差分析进行评估。
魁北克康复研究所中心综合大学健康与社会服务伦理委员会已批准该研究。结果将通过在同行评议期刊上发表国际出版物以及国际会议报告来传播。
方案于 2016 年 8 月 25 日在 ClinicalTrials.gov(NCT02881021)注册。还可以在在线补充文件中找到世界卫生组织试验注册数据集。