Functional treatment is a widely used and generally accepted treatment for ankle sprain. A number of studies assessing the effectiveness of different conservative treatments of acute ankle sprain have been performed, but until now, little was known about patient satisfaction in relation to the functional outcome. The results of this randomized controlled trial comparing semi-rigid ankle brace with tape treatment demonstrated improved patient satisfaction with less local complications in patients treated with a semi-rigid brace, but overall showed no improved functional outcome.
Previously, two studies compared patient satisfaction with treatment using brace. In total 76% of patients treated with a brace in the study by Jongen et al. [8
] were very satisfied or satisfied with brace treatment, while in our study 95% of patients qualified their satisfaction as excellent or good. This higher percentage may be due to another design of the brace with a more rigid lateral and medial support in our study. Patients in the ankle brace group in the randomized trial from Boyce et al. [16
] reported higher levels of comfort and satisfaction, although the used methods to evaluate satisfaction were not specified. The functional outcome Karlsson score was also significantly higher in the brace group compared to that in the elastic bandage group at 10
days and one month.
Kerkhoffs et al. [5
] reviewed different functional treatment strategies for acute lateral ankle ligament injuries in adults in a meta-analysis. Although it was impossible to make definitive conclusions about the most effective functional treatment because diversity of outcome results prohibited pooling of results, there seemed to be no evidence that using a semi-rigid brace is superior to taping concerning functional outcome in the individual studies. A semi-rigid ankle support provided more stability and a quicker return to work and sport than an elastic bandage [5
]. In addition, as for the functional outcome, objective (ROM) as well as patient-reported functional outcome score (Karlsson scale), this study shows that there was no difference functional ability between the two groups. In addition, the pain score was similar between the tape and semi-rigid brace treatment at 3
months. However, tape treatment resulted in significantly more complications, the majority being skin irritations, when compared with treatment with an elastic bandage [5
] . In line with these data, this study showed that functional treatment with a semi-rigid brace leads to significant less complications than treatment by taping (RR 0.11; 95% CI 0.01 to 0.86). These results match previous other published studies [5
A number of remarks must be made when interpreting these observations. Although the loss of follow-up for the primary outcome parameters was 17% at 5
weeks, incomplete data on the secondary outcome parameters was higher with a loss to follow-up for the secondary outcome parameter of 29% at 13
weeks. This loss to follow-up may have introduced misclassification bias [17
]. Although the lost-to-follow up was equally distributed among treatment groups and remains below the cut-off value of 80% for the primary outcome parameter, this is not the case for the secondary outcome parameter (Fewtrell MS. Arch Dis Child, 2008;93(6):458-461). Post hoc power analysis indicated that 25 patients should be analyzed in both groups to detect the differences in patients satisfaction score as found in our study. For detecting differences in Karlsson score post hoc power analysis indicated >100.000 patients should be included.
In addition, the costs of treatment with a semi-rigid brace are higher than the treatment with a tape. Diercks et al. [18
] described the effectiveness and costs in relation to the patient satisfaction in a small study on the treatment of acute ankle sprain with tape and treatment with a brace and found higher patient satisfaction, but also higher costs of the treatment with a semi-rigid brace (€183 versus €238) Specification of the costs are illustrated in the article by Diercks et al. This comparison seems to be different when tape and brace interventions are used as a preventive measure. In a study by Olmsted et al. found that the costs of preventing one ankle sprain was significantly higher using preventive tape treatment compared to preventive brace treatment [19
]. The treatment of an ankle sprain using tape in our study was cheaper mainly due to material costs than treatment with a semi-rigid brace (total costs: €167 (diagnostic costs 121; working costs 27; material costs 8; overhead 11) versus €204, (diagnostic costs 121; working costs 22; material costs 35; overhead 26), respectively). A higher level of comfort during treatment of an ankle sprain therefore comes at the expense at higher treatment costs.