Abstract
BackgroundCryotherapy (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/DesignThe 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 (activPAL™ 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).DiscussionThis 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.Trial RegistrationISRCTN13903946
Highlights
Cryotherapy is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury
Sprains of the lateral ankle ligaments are associated with significant costs [1] and account for an estimated 302,000 annual admissions to Accident & Emergency (A&E) Departments in the UK [2]
We have described the rationale and design of a randomised controlled trial comparing standard intermittent versus cryokintic ice applications in the early management of acute grade I and grade II ankle sprain. Such injuries are often regarded as being fairly innocuous, recurrent sprains and sensations of instability are a frequent sequelae of lateral ankle sprain
Summary
We have described the rationale and design of a randomised controlled trial comparing standard intermittent versus cryokintic ice applications in the early management of acute grade I and grade II ankle sprain. Such injuries are often regarded as being fairly innocuous, recurrent sprains and sensations of instability are a frequent sequelae of lateral ankle sprain. The process of ensuring all potential patients are assessed for study eligibility will be aided by the researchers being based in A&E on a day to day basis, by working closely with Emergency Nurse Practitioners responsible for triage assessment, and by providing regular trial updates for other relevant clinical staff. Results of the trial will be disseminated through publication in relevant peer-reviewed journals and conference proceedings
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