None listed
Conditions
Brief summary
The standard treatment regimen for uncomplicated ankle sprains comprises ‘RICE’ (Rest, Ice, Compression and Elevation). Assuming the patient is compliant then rest, compression and elevation can be applied with some consistency. Anecdotally, however, the application of ice to the affected area is more variable. This results from the availability of ice itself and the variability in which it is applied. Large ice blocks, chipped ice and ‘frozen peas’ could be expected to have differing levels of effectiveness. Furthermore, the areas of the affected part actually in contact with this ‘ice’ may vary considerably, depending upon the technique. Frozen gel packs have been used as an alternative to ice. However, these can be too cold and have been known to induce skin and subcutaneous tissue damage. They also lack ‘compliance’ when frozen and may be difficult to wrap around the injured area effectively. Recently, a polymer gel has been developed that has the properties of gentle and sustained extraction of heat from the environment (convection) and contacting surfaces (conduction). This gel can be modified to continue heat extraction until its own temperature reaches a pre-determined level of 6oC. This polymer gel can be fashioned into small or large plates that can be inserted into a variety of cloth garments for application to a range of body parts. It has been successfully employed in cooling vests to avoid heat stress and improve the performance of elite athletes. Does treatment with a gel polymer cooling regimen result in better function and reduced pain compared to traditional ice in the acute management of uncomplicated ankle sprains? This study will be a non-blinded randomised controlled trial comparing the use of standard ice with a cloth booty containing cooling gel polymer as an adjunct for treating sprained ankles. 135 patients will be randomised to one of three groups: episodic ankle cooling with ice, episodic cooling with gel polymer booty and continuous daytime cooling with the gel polymer booty. Each cooling regimen will last for at least 48 hours and all other treatments provided will be follow usual guidelines. Outcome measures of pain and ankle function will be sought at 5 and 15 days post-injury by telephone follow up. The findings of this study will inform best practice management of this common injury.
Interventions
Randomised to 1 of 3 groups. The first group will apply ice to the affected ankle for 20 minutes every 2 hours while awake, for at least 48 hours, in keeping with standard discharge advice. The second grou
Randomised to 1 of 3 groups. The first group will apply ice to the affected ankle for 20 minutes every 2 hours while awake, for at least 48 hours, in keeping with standard discharge advice. The second group will wear a booty (containing cooling gel polymer) on the affected ankle for 20 minutes every 2 hours while awake, for at least 48 hours. The third group will wear the gel polymer booty on the affected ankle continuously throughout the day, for at least 48 hours. All participants will be telephoned on days 5 and 15 after the injury.
Sponsors
Royal Melbourne Hospital Emergency department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Grades 1, 2 and 3 lateral ligament sprains after an ankle inversion injury, presenting within 24 hours of injury.
Exclusion criteria
Isolated deltoid ligament injury, >24 hours since injury occurrence, fractures, multiple injuries, residual symptoms from a previous injury, dementia, mental illness, intoxication (alcohol or drugs), long term disability problems, neurological problems, inability to contact for follow up, language or other communication difficulties.
Outcome results
None listed