Kim Jae-Hong, Cho Myung-Rae, Park Ju-Hyung, Shin Jeong-Cheol, Cho Ji-Hyun, Park Gwang-Cheon, Nam Dongwoo
Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dong-Shin University, Naju City, Republic of Korea.
Clinical Research Center, DongShin University Gwangju Oriental Hospital, Gwangju City, Republic of Korea.
Trials. 2018 Feb 20;19(1):125. doi: 10.1186/s13063-018-2527-5.
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.
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.
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).
踝关节扭伤是肌肉骨骼系统最常见的损伤之一。然而，尚无确凿证据支持哪种治疗策略更优。使用肌内效贴布（KT）进行贴扎是一种新方法，可替代用于预防和治疗踝关节扭伤的更成熟的贴扎和支具技术。本研究的目的是通过比较急性外侧踝关节扭伤患者中针刺联合KT（AcuKT）与单纯针刺的疗效，来检验KT对踝关节扭伤的效果。
方法/设计：本研究是一项前瞻性、多中心（东新大学光州韩医医院、东新大学木浦韩医医院和庆熙韩医医院）、结局评估者盲法、随机对照临床试验，分配比例为1:1。研究开始后1周内发生外侧踝关节扭伤的参与者（n = 60）将被随机分配到针刺组（每个中心n = 10（共n = 30））或AcuKT组（每个中心n = 10（共n = 30））。针刺组将在足三里（ST36）、解溪（ST41）、昆仑（BL60）、仆参（BL62）、太溪（KI3）、照海（KI6）、丘墟（GB39）和足临泣（GB40）接受针刺治疗，每天1次，每周5天（周六和周日除外），共1周。AcuKT组将在足三里（ST36）、解溪（ST41）、昆仑（BL60）、仆参（BL62）、太溪（KI3）、照海（KI6）、丘墟（GB39）和足临泣（GB40）接受针刺治疗，并对踝关节经络肌腱肌肉组织进行KT治疗，呈8字形贴扎，每天1次，每周5天（周六和周日除外），共1周。主要结局将根据视觉模拟量表（VAS）评估疼痛，而足踝结局评分（FAOS）、水肿、欧洲五维健康量表（EQ-5D-5L）评分和踝关节扭伤复发次数将被视为次要结局指标。VAS、FAOS和水肿测量将在基线（干预前）、首次干预后5天（即干预结束时）和干预完成后4周进行。EQ-测量将在基线、首次干预后5天、干预完成后4周和干预完成后26周进行。踝关节扭伤复发次数将在干预完成后4、8、12和26周确定。
本研究将提供关于KT治疗急性外侧踝关节扭伤疗效的数据。结果可能有助于深入了解KT在治疗急性外侧踝关节扭伤中的作用。
cris.nih.go.kr，ID：KCT0002257。于2017年2月27日注册，并获得食品药品安全部批准（医疗器械临床试验方案批准号#737）。
