Extrait

Background and study aims Ankle sprains are one of the most common soft tissue injuries, mostly involving the ligaments (strong bands of tissue connecting together bones) on the outside of the ankle. Many people go to A&E with a sprained ankle every year, with the extent of injury varying from minor stretching to complete tear of the ligaments. The injury itself is painful and, unless minor, makes walking difficult. Symptoms generally last for weeks but, for a significant minority of people, they can actually last for months or years. Treatment generally depends on how bad the injury is but includes advice, self care, physiotherapy, ankle support, immobilisation and surgical repair. It is often very difficult to determine how serious the injury is at initial presentation, due to the swelling and pain caused by the injury. Simple tests like standing on one leg can help to determine how bad the injury is. Summaries of the research literature conclude there is a lack of good-quality evidence to help clinical decision-making. Probably as a result of this, there is no standard guideline for UK emergency department (ED) clinicians to follow, so clinical practice varies. Our group have completed a large study looking at which types of ankle support are best for severe sprains. We are planning to use the data from this trial to develop a tool that will help clinicians assess the risk of patients having a good or poor recovery. We will then check how well it works in a new set of patients recruited from A&Es around the UK. Who can participate? Adult patients with ankle sprains. What does the study involve? The participants taking part in this study are followed up at set times by questionnaire over nine months. We believe poor recovery means serious problems with level of activity, pain, confidence/stability of the ankle and/or recurrent injury. It is a combination of these measures that we try and predict using a combination of clinical and patient reported measures taken at A&E visits. Examples include age, sex, ability to walk, stability of the ankle and swelling. To aid us in developing the prognostic model, we review the current research literature and consult clinical experts and patients on what are important factors and outcomes. Decisions are made from a choice of candidate tools, options on the presentation of tools and potential additional measurements. The decisions will be made at a face to face meeting called a Modified Nominal Group which aims to gain consensus on decisions. At the end of the two and a half years of research we aim to have developed a tool that will give a guide as to the chances of recovery for individual patients. A&E clinicians could then modify treatment or refer patients early for specialist treatment if they are at risk of poor recovery which could lead to more successful treatments and reduced costs to the NHS and society. What are the possible benefits and risks of participating? As this research is focused on using information, some of which is already routinely collected, the risk of harm is very low. The study will not interfere with ankle sprain treatment or any later rehabilitation participants might receive from their General Practitioner or Physiotherapist. We do not promise the study will help participants in particular, but the information we get from this study may help improve the NHS treatment for people with ankle sprains in the future Where is the study run from? A&E departments run by one of eight NHS trusts in the UK. When is the study starting and how long is it expected to run for? June 2015 to April 2017 Who is funding the study? National Institute for Health Research (HTA programme). Who is the main contact? 1. Mr Daryl Hagan (public) [email protected] 2. Dr David Keene (scientific)

Critère d'inclusion

• ANKLE SPRAIN

Liens

• ictrp
• isrctn