Pragmatic randomised controlled trial.Objectives
To determine the effect of adding analgesics to a standardised rehabilitation program following lateral ankle sprain (LAS) on long-term outcome measures.Background
Recent guidelines report strong evidence that a short course of certain analgesics may decrease pain and improve function following lateral ankle sprain (LAS). However, reports of swelling and static instability in subjects receiving non-steroidal anti-inflammatories (NSAIDs) following LAS have led to concerns of adverse healing and have been criticised for short-term follow-ups and limited outcome measures.Methods and Measures
All Canadian Armed Forces (CAF) members reporting to Garrison Petawawa with an acute grade I/II LAS were invited to participate. Eligible subjects were provided a standardised rehabilitation program and randomised to receive either; no medication or a 7 day course of: acetaminophen 500 mg four times/day, celecoxib 100 mg twice/day, or naproxen 500 mg twice/day. In order to determine a statistically significant difference between groups in the Activities of Daily Living subscale of the Foot and Ankle Abilities Measure, using a two-sided significance set at 0.05, a power of 80%, and an estimated attrition rate of 25%, 40 subjects/group were required. Secondary outcome measures included clinical measures of pain, swelling, mobility and instability at 2, 4 and 52 weeks.Results
To date, 66 subjects have been enrolled and randomised into the; no medication (n=17, 28.3±9.9 years), acetaminophen (n=17, 28.6±7.2 years), celecoxib (n=16, 51.8±14.9 years), or naproxen (n=17, 32.7±10.7 years) groups. All subjects have reported clinically relevant changes in pain and self-reported function between baseline and 3 months, without any differences static instability. Interestingly, only subjects in the no medication or acetaminophen groups have reported clinically relevant changes in swelling.Conclusion
The preliminary results of this study suggest that the concerns regarding adverse effects on healing and delayed recovery in subjects receiving NSAIDs following LAS may require reconsideration.