Add-on effect of Kinesiotape in patients with acute lateral ankle sprain: a randomized controlled trial
Abstract Background: Evidence on the add-on effect of Kinesiotape (KT) on acupuncture for treating ankle sprains remains insufficient. We assessed the add-on effect of KT on ankle sprains by comparing acupuncture combined with KT (AcuKT) with acupuncture alone in patients with acute lateral ankle sprain (ALAS). Methods: This study was a multicenter, randomized, controlled clinical trial that included a per-protocol analysis of the add-on effect of KT on ALAS. The randomization was software-based and only the assessors were blinded. Sixty participants (20 each from three centers) with Grade I or II ALAS were randomly assigned to acupuncture (n=30) or AcuKT (n=30) group. Both groups received acupuncture treatment once daily, 5 days per week for 1 week. The AcuKT group received additional KT treatment. Visual analog scale (VAS) scores for pain and Foot and Ankle Outcome Score (FAOS) were obtained, and edema measurements were performed at baseline (Week 0), at the end of the intervention (Week 1), and at 4 weeks after intervention (Week 5). The European Quality of Life Five Dimension-Five Level Scale (EQ-5D-5L) measurements were conducted at Week 0, Week 1, Week 5, and Week 26 after the intervention. The number of recurrent ankle sprains was determined at 4, 8, 12, and 26 weeks after the intervention. Results: Fifty-six patients with ALAS completed the trial (AcuKT group, 27; acupuncture group, 29). There were significant changes in VAS score (AcuKT: p<0.001; acupuncture: p<0.001), FAOS (AcuKT: p<0.001; acupuncture: p<0.001), and EQ-5D-5L measurements (AcuKT: p<0.001; acupuncture: p<0.001) within both groups. There were no significant differences between groups in terms of any outcome and in a subanalysis based on symptom severity. Conclusions: These results indicate that AcuKT did not show positive add-on effects of KT on acupuncture in terms of pain reduction, edema, recovery of function, activities of daily living, quality of life, and relapse of ALAS.