针对肩痛患者的定制康复与标准强化方案的有效性：一项可行性随机对照试验（奥塔哥 MASTER 试验）方案。
Effectiveness of a tailored rehabilitation versus standard strengthening programme for patients with shoulder pain: a protocol for a feasibility randomised controlled trial (the Otago MASTER trial).
机构信息
School of Physiotherapy, University of Otago, Dunedin, New Zealand
School of Physiotherapy, University of Otago, Dunedin, New Zealand.
出版信息
BMJ Open. 2019 Jul 30;9(7):e028261. doi: 10.1136/bmjopen-2018-028261.
INTRODUCTION
Exercise therapy is the treatment of choice for the management of patients with shoulder subacromial pain. However, we do not know whether a tailored rehabilitation programme is more effective than a standardised strengthening programme. The aim of this feasibility trial is to assess: (1) participant recruitment rate, (2) the proportion of participants enrolled from the total number screened, (3) adherence to the rehabilitation programme, (4) drop-out rates, (5) obtain estimates of adverse reactions to treatment, (6) obtain estimates of intervention effects in order to inform the sample size of the fully-powered randomised controlled trial, (7) conduct a preliminary cost-effectiveness analysis of the standardised strengthening and the tailored rehabilitation interventions.
METHODS
The MAnagement of Subacromial disorders of The shouldER (MASTER) trial, is a two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial. Participants will be randomly allocated into one of the interventions group: tailored or standardised rehabilitation. To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. To determine whether it is feasible to conduct the full trial, we will consider 75% CI as the probability threshold at 3-month follow-up.
ETHICS AND DISSEMINATION
This study was approved by the University of Otago Ethics Committee (Ref: H17/080). Findings from this study will be presented at national and international conferences, and will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ANZCTR: 12617001405303.
简介
运动疗法是治疗肩峰下疼痛患者的首选治疗方法。然而，我们尚不清楚量身定制的康复方案是否比标准化的强化方案更有效。本可行性试验旨在评估：（1）参与者的招募率，（2）从筛查的总人数中招募参与者的比例，（3）对康复方案的依从性，（4）脱落率，（5）治疗不良反应的发生率，（6）获得干预效果的估计值，以告知完全随机对照试验的样本量，（7）对标准化强化和量身定制的康复干预措施进行初步成本效益分析。
方法
MAnagement of Subacromial disorders of The shouldER（MASTER）试验是一项两臂、患者盲法和评估者盲法、随机对照可行性试验。参与者将被随机分配到以下干预组之一：量身定制或标准化康复。为了评估干预效果，我们将使用重复混合模型方差分析比较两组干预措施之间疼痛和肩部相关残疾评分的变化，alpha 值设定为 0.05，效能为 80%。由于这是一项可行性研究，我们不会对多重比较进行 alpha 调整。为了确定是否可以进行全试验，我们将在 3 个月随访时考虑 75%CI 作为概率阈值。
伦理和传播
本研究已获得奥塔哥大学伦理委员会的批准（Ref：H17/080）。本研究的结果将在国内外会议上进行报告，并将提交给同行评议期刊发表。
试验注册编号
ANZCTR：12617001405303。
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