Acknowledgements

We wish to acknowledge that CAST was funded by the UK Department of Health through its Health Technology Assessment Programme.
The opinions and conclusions expressed here are those of the authors and do not necessarily reflect those of the UK National Health Service or the Department of Health.

Aim of the Project                         Results are now available                                 

A randomised controlled trial designed to estimate the clinical and cost effectiveness of three different methods of mechanical support compared with Tubigrip in the treatment of severe ankle sprains.  The three supports being compared with Tubigrip are below knee cast (for 10 days only), an Aircast brace and a Bledsoe Boot.  Supports will be applied two to three days after injury in order to allow the initial swelling to subside.

Method

600 patients who present with severe ankle sprains (are unable to weight-bear) and give informed consent will be recruited, randomised to one of the four treatment groups, and followed up 4 weeks, 12 weeks and 9 months after injury. The primary outcome measure of return to function will be assessed using the Foot and Ankle Outcome Score (FAOS) questionnaire, and the Functional Limitations Profile (FLP) questionnaire.  A resource use questionnaire will be used to collect economic data and the Short Form 12 (SF-12) and EURO-QoL (EQ-5D) questionnaires will be used to assess quality of life pre- and post-injury.

Project Schedule

November 2002 - June 2006

Personnel

Collaborating Centres

Results (June 2006)

584 patients with severe ankle sprain were recruited to the trial and followed up for nine months.  Analysis of the data has just finished, and  has produced some very interesting results, although perhaps not quite what we might have expected before the trial began.

At 4 weeks after injury, comparing the three supports listed above with Tubigrip, plaster was the one that gave the best result in terms of patients' pain, other symptoms and ankle-related quality of life.  The Aircast brace gave slightly better results than Tubigrip but not as good as below knee cast.  Bledsoe boot was not any better than Tubigrip. 

At 12 weeks following injury, below knee cast was still better than Tubigrip for pain and also gave a better result than Tubigrip for patients' ability to perform sports, activities of daily living and their ankle-related quality of life. The Aircast brace also gave good results for quality of life and a faster return to normal than below knee cast when looking at mental well-being.

By 9 months there were no significant differences between the four different supports.

Below knee cast was also the most cost-effective treatment when healthcare costs and sick-leave were taken into account.

Publications/Presentations to Date

A survey of current consultant practice of treatment of severe ankle sprains in emergency departments in the United Kingdom. Cooke MW*, Lamb SE**, Marsh J*, Dale J*. Presented at Faculty of A&E Medicine Conference, Plymouth, November 2002 and published in EMJ 2004

Conducting clinical trials in accident and emergency medicine - a pilot study highlights recruitment challenges . Nakash RA, Lamb SE, Cooke MW. Presented at FAEM conference, London, November 2003.  Click here for poster.

Tubigrip

Plaster of Paris

Aircast brace

Bledsoe boot

PUBLIC INFORMATION

Patient study information (pdf)

Patient injury information (pdf)

HTA project information

ISRCTN register entry