Journal Article

The effects of Kinesiotape on acute lateral ankle sprain: study protocol for a randomized controlled trial

Myung-Rae Cho, Jae-Hong Kim, Ju-Hyung Park, Jeong-Cheol Shin, Gwang-Cheon Park, Dongwoo Nam, Ji-Hyun Cho

2018

Overview

Background Ankle sprains are some of the most frequent injuries of the musculoskeletal system. However, there is no substantive evidence supporting which treatment strategy is superior. Taping with Kinesiotape (KT) is a new method that is used as an alternative to the more established taping and bracing techniques used for the prophylaxis and treatment of ankle sprains. The aim of this study is to examine the efficacy of KT on ankle sprain by comparing acupuncture combined with KT (AcuKT) with acupuncture alone in patients with acute lateral ankle sprains. Methods/design This study is a prospective, multi-center (DongShin University Gwangju Oriental Hospital, DongShin University Mokpo Oriental Hospital, and KyungHee Korean Medicine Hospital), outcome assessor-blinded, randomized controlled clinical trial with a 1:1 allocation ratio. Participants ( n = 60) with a lateral ankle sprain occurring within 1 week of the study will be randomly assigned to either an acupuncture group ( n = 10 at each center (total n = 30)) or an AcuKT group ( n = 10 at each center (total n = 30)). The acupuncture group will receive acupuncture treatment at ST36, ST41, BL60, BL62, KI3, KI6, GB39, and GB40 once per day, 5 days per week (excluding Saturday and Sunday) for 1 week. The AcuKT group will receive acupuncture treatment at ST36, ST41, BL60, BL62, KI3, KI6, GB39, and GB40 and the ankle meridian tendino-musculature and a figure-of-eight shape form of KT treatment once per day, 5 days per week (excluding Saturday and Sunday) for 1 week. The primary outcome will be pain evaluation assessed according to a Visual Analogue Scale (VAS), while Foot and Ankle Outcome Score (FAOS), edema, European Quality of Life Five Dimension-Five Level Scale (EQ-5D-5 L) score, and number of recurrent ankle sprains will be considered as secondary outcome measures. VAS, FAOS, and edema measurements will be performed at baseline (before intervention), 5 days after the first intervention (i.e. , at the end of the intervention), and 4 weeks after the completion of intervention. EQ-5D-5 L measurements will be conducted at baseline, 5 days after the first intervention, 4 weeks after the completion of intervention, and 26 weeks after the completion of intervention. The number of recurrent ankle sprains will be determined at 4, 8, 12, and 26 weeks after the completion of the intervention. Discussion This study will provide data regarding the efficacy of KT for the treatment of acute lateral ankle sprain. The results may lead to insights into the usefulness of KT in the treatment of acute lateral ankle sprain. Trial registration cris.nih.go.kr, ID: KCT0002257. Registered on 27 February 2017, and approved by the Ministry of Food and Drug Safety (Medical Device Clinical Trial Plan Approval #737).

• Publisher: Springer Science and Business Media LLC,BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Acupuncture / Acupuncture Therapy / Acupuncture Therapy - adverse effects / Acute Disease / Adhesive tape / Adult / Ankle / Ankle Injuries / Ankle Injuries - therapy / Ankle sprain / Athletic Tape / Athletic Tape - adverse effects / Athletic taping / Biomedicine / Clinical trials / Data Interpretation, Statistical / Health aspects / Health Sciences / Hemorrhage / Hospitals / Humans / Hypotheses / Informed consent / Injuries / Intervention / Kinesiotape / Ligaments / Medicine / Medicine & Public Health / Medicine (General) / Multicenter Studies as Topic / Nervous system / Outcome Assessment, Health Care / Pain / Prospective Studies / Quality Assurance, Health Care / R5-920 / Randomized controlled trial / Randomized Controlled Trials as Topic / Skin / Statistics for Life Sciences / Study Protocol