Bleakley Chris M, O'Connor Seán, Tully Mark A, Rocke Laurence G, Macauley Domnhall C, McDonough Suzanne M
Health & Rehabilitation Sciences Research Institute, University of Ulster, Jordanstown, Northern Ireland, UK.
BMC Musculoskelet Disord. 2007 Dec 19;8:125. doi: 10.1186/1471-2474-8-125.
Cryotherapy (the application of ice for therapeutic purposes) is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury. Despite its widespread clinical use, the precise physiological responses to therapeutic cooling have not been fully elucidated, and effective evidence-based treatment protocols are yet to be established. Intermittent ice applications are thought to exert a significant analgesic effect. This could facilitate earlier therapeutic exercise after injury, potentially allowing for a quicker return to activity. The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain.
METHODS/DESIGN: The study is a randomised controlled trial. 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic. Subjects will be randomised under strict double-blind conditions to either a standard cryotherapy (intermittent ice applications with compression) or cryokinetic treatment group (intermittent ice applications with compression and therapeutic exercise). After the first week, treatment will be standardised across groups. Assessor blinding will be maintained throughout the trial. Primary outcome will be function, assessed using the Lower Extremity Functional Scale (LEFS). Additional outcomes will include pain (10 cm Visual Analogue Scale), swelling (modified figure-of-eight method) and activity levels (activPALtrade mark physical activity monitor, PAL Technologies, Glasgow, UK). Diagnostic Ultrasound (Episcan-1-200 high frequency ultrasound scanning system, Longport International Ltd, PA) will also be used to assess the degree of soft tissue injury. After baseline assessment subjects will be followed up at 1, 2, 3 & 4 weeks post injury. All data will be analysed using repeated measures analysis of co-variance (ANCOVA).
This paper describes the rationale and design of a randomised controlled trial which will examine the effectiveness of two different cryotherapy protocols in the early management of acute ankle sprain.
ISRCTN13903946.
冷冻疗法（将冰敷用于治疗目的）是急性软组织损伤即时处理中最常用的治疗方式之一。尽管其在临床广泛应用，但对治疗性降温的确切生理反应尚未完全阐明，且基于证据的有效治疗方案尚未确立。间歇性冰敷被认为具有显著的镇痛效果。这可能有助于损伤后更早地进行治疗性锻炼，有可能使伤者更快恢复活动。因此，即将开展的这项研究的主要目的是，检验急性踝关节扭伤后第一周内，间歇性冰敷与治疗性锻炼相结合的安全性和有效性。
方法/设计：本研究为一项随机对照试验。将从急诊室和一所大学的运动损伤诊所招募120名急性I级或II级踝关节扭伤患者。在严格的双盲条件下，将受试者随机分为标准冷冻疗法组（间歇性冰敷并加压）或冷冻运动疗法组（间歇性冰敷并加压以及进行治疗性锻炼）。第一周后，各治疗组的治疗方法将实现标准化。在整个试验过程中，评估人员保持盲态。主要结局指标为功能，采用下肢功能量表（LEFS）进行评估。其他结局指标将包括疼痛（10厘米视觉模拟量表）、肿胀（改良的8字形法）和活动水平（activPAL商标身体活动监测仪，PAL Technologies公司，格拉斯哥，英国）。还将使用诊断超声（Episcan - 1 - 200高频超声扫描系统，Longport International Ltd公司，宾夕法尼亚州）评估软组织损伤程度。在基线评估后，将在受伤后1、2、3和4周对受试者进行随访。所有数据将采用重复测量协方差分析（ANCOVA）进行分析。
本文描述了一项随机对照试验的原理和设计，该试验将检验两种不同冷冻疗法方案在急性踝关节扭伤早期处理中的有效性。
ISRCTN13903946
