肌内效贴对急性外踝扭伤患者的附加效应：一项随机对照试验。
Add-on effect of kinesiotape in patients with acute lateral ankle sprain: a randomized controlled trial.
机构信息
Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, DongShin University, Naju City, 58245, Republic of Korea.
Clinical Research Center, DongShin University Gwangju Korean Medicine Hospital, 141, Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea.
出版信息
Trials. 2020 Feb 12;21(1):176. doi: 10.1186/s13063-020-4111-z.
BACKGROUND
Evidence for the add-on effect of kinesiotape (KT) with 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) groups. 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 the 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-5 L) 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, n = 27; acupuncture group, n = 29). There were significant changes in visual analog scale score (AcuKT, P < 0.001; acupuncture, P < 0.001), the FAOS (AcuKT, P < 0.001; acupuncture, P < 0.001), and EQ-5D-5 L measurements (AcuKT, P < 0.001; acupuncture, P < 0.001) within both groups. There were no significant differences between groups in terms of any outcome or in a subanalysis based on symptom severity.
CONCLUSIONS
These results indicate that AcuKT did not show a positive add-on effect of KT with acupuncture in terms of pain reduction, edema, recovery of function, activities of daily living, quality of life or relapse of ALAS.
TRIAL REGISTRATION
Clinical Research Information Service (cris.nih.go.kr), KCT0002257. Registered on 27 February 2017.
背景
关于运动贴布（KT）联合针刺治疗踝关节扭伤的附加疗效证据仍然不足。我们通过比较急性外踝扭伤（ALAS）患者针刺联合 KT（AcuKT）与单纯针刺的疗效，评估 KT 的附加疗效。
方法
这是一项多中心、随机对照临床试验，对 KT 的附加疗效进行了意向性治疗分析。随机化基于软件，仅评估者设盲。60 名 I 或 II 级 ALAS 患者（每个中心 20 名）被随机分为针刺组（n=30）或 AcuKT 组（n=30）。两组均接受每日 1 次、每周 5 天、持续 1 周的针刺治疗。AcuKT 组接受额外的 KT 治疗。在基线（第 0 周）、干预结束时（第 1 周）和干预后 4 周（第 5 周）时测量视觉模拟评分（VAS）疼痛评分和足踝结局评分（FAOS），并测量肿胀。欧洲生活质量五维问卷-五水平量表（EQ-5D-5L）测量在第 0 周、第 1 周、第 5 周和干预后 26 周进行。在干预后 4、8、12 和 26 周时确定复发性踝关节扭伤的次数。
结果
56 名 ALAS 患者完成了试验（AcuKT 组，n=27；针刺组，n=29）。两组 VAS 评分（AcuKT，P<0.001；针刺，P<0.001）、FAOS（AcuKT，P<0.001；针刺，P<0.001）和 EQ-5D-5L 测量值（AcuKT，P<0.001；针刺，P<0.001）均有显著变化。两组在任何结局或基于症状严重程度的亚分析中均无显著差异。
结论
这些结果表明，在减轻疼痛、消肿、功能恢复、日常生活活动、生活质量或 ALAS 复发方面，AcuKT 并未显示 KT 联合针刺的阳性附加疗效。
试验注册
临床研究信息服务（cris.nih.go.kr），KCT0002257。注册于 2017 年 2 月 27 日。
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