Ice versus “synthetic ice” gel polymer for the treatment of ankle sprain: a randomized, controlled clinical trial

INTERVENTION: 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. CONDITION: Grades 1, 2 and 3 lateral ligament sprains following an ankle inversion injury PRIMARY OUTCOME: Ankle joint function will be assessed using the “Karlsson scoring system” (see Boyce 2005). This is a validated composite of eight “weighted” variables (eg. pain, swelling, stiffness etc). A score of 90 indicates no ankle problem and the lower the score, the worse the ankle. Does treatment of acute ankle sprains with the polymer gel compression boot improve the Karlsson ankle score by at least 15 points when compared with traditional treatment using ice? SECONDARY OUTCOME: Likert 0‐10 pain score on walking 4 steps Patient’s Global Assessment of Ankle Injury (see Petrella 2004) Patient’s reported outcome (see Patrick 1995) INCLUSION CRITERIA: Grades 1, 2 and 3 lateral ligament sprains after an ankle inversion injury, presenting within 24 hours of injury.