Clausen Mikkel Bek, Bandholm Thomas, Rathleff Michael Skovdal, Christensen Karl Bang, Zebis Mette Kreutzfeldt, Graven-Nielsen Thomas, Hölmich Per, Thorborg Kristian
Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, Metropolitan University College, Sigurdsgade 26, DK-2200, Copenhagen N, Denmark.
Sports Orthopaedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Kettegårds Allé 30, DK-2650, Hvidovre, Denmark.
Trials. 2018 Mar 2;19(1):154. doi: 10.1186/s13063-018-2509-7.
Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4-13%. As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation. The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established.
A pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts.
If effective, the simple shoulder strengthening exercise programme investigated in this trial could easily be added to usual care. The usefulness of the trial is further supported by the magnitude of the problem, the information gained from the study and the pragmatism, patient centeredness and transparency of the trial.
The trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.
肩峰下撞击综合征（SIS）是一种疼痛且通常持续时间较长的肩部疾病，会影响患者的功能和生活质量。在最近的一项研究中，我们观察到在患有明显且长期的SIS的患者群体中，肩部外旋和外展力量有显著损伤（约30%）。然而，目前针对此类力量损伤的康复治疗可能并不充分，包括运动疗法的新型康复方案仅能使外旋力量提高4% - 13%。由于这些先前的研究是当前实践的基础，这表明在这些患者的康复中，强化部分可能不足，似乎应该更加强调加强这部分康复。本研究的目的是调查一项由使用弹力带进行渐进式家庭抗阻训练组成的方案的有效性，该方案旨在提高肩部外旋和外展力量，在确诊后不久添加到常规护理中。
将进行一项实用的随机对照优势试验，纳入200例根据预定义标准诊断为明显且长期的SIS的患者。参与者将按1:1的分配比例随机接受除常规护理外使用弹力带进行渐进式家庭抗阻训练的附加干预或仅接受常规护理。随机化序列由计算机生成，采用随机大小的置换块。主要结局将是从基线到16周随访时肩痛与功能障碍指数（SPADI）评分的变化。结局评估者对分组情况不知情。干预接受者在分组最终确定之前，通过关于附加干预和对照情况内容的最少信息，对治疗分配不知情。由不知情的数据分析师进行分析。
如果有效，本试验中研究的简单肩部强化运动方案可以很容易地添加到常规护理中。该问题的严重程度、从研究中获得的信息以及试验的实用性、以患者为中心和透明度进一步支持了该试验的有用性。
该试验于2016年4月19日在ClinicalTrials.gov上进行预注册，标识符为NCT02747251。
