针刺头皮运动区治疗缺血性脑卒中患者运动功能障碍：一项随机对照试验的研究方案
Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial.
作者信息
Wang Jun, Pei Jian, Khiati Dhiaedin, Fu Qinhui, Cui Xiao, Song Yi, Yan Minghang, Shi Lijun, Cai Yiwen, Ma Yuhong
机构信息
Department of Acupuncture, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South WanPing Road, XuHui District, Shanghai, 200032, China.
Department of Rehabilitation, Shanghai Changning District Tianshan Hospital of Traditional Chinese Medicine, No. 868 Loushanguan Road, Changning District, Shanghai, 20005l, China.
出版信息
Trials. 2017 Jun 20;18(1):287. doi: 10.1186/s13063-017-2000-x.
BACKGROUND
Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in patients with stroke in China, especially the motor area of Jiao's scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for stroke remains uncertain. Meanwhile, no randomized controlled trials on Jiao's scalp acupuncture have been performed. The aim of this study is to evaluate the efficacy and safety of Jiao's scalp acupuncture for motor dysfunction in ischemic stroke.
METHODS/DESIGN: This is an assessor- and analyst-blinded, randomized controlled trial. One hundred and eight stroke patients with motor dysfunction meeting the inclusion criteria will be allocated by a 1:1 ratio into either an acupuncture treatment group or a control group. Stroke patients in the control group will receive conventional rehabilitation treatment, whereas a combination of Jiao's scalp acupuncture and conventional rehabilitation treatment will be applied to the acupuncture group. Forty treatment sessions will be performed over an 8-week period. The Fugl-Meyer Assessment scale will be assessed as the primary outcome measure. The Modified Barthel Index, the Stroke-Specific Quality of Life, and the Stroke Syndrome of Traditional Chinese Medicine scales will be selected as secondary outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 20), week 8 (treatment 40), week 12 (follow-up), and week 16 (follow-up).
DISCUSSION
This is the first trial evaluating the efficacy and safety of Jiao's scalp acupuncture for motor dysfunction in ischemic stroke. The results of this trial are expected to provide relevant evidence demonstrating that Jiao's scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in ischemic stroke.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02871453 . Registered on 17 July 2016.
背景
在中国，头皮针疗法对中风患者的运动功能障碍显示出显著的治疗效果，尤其是焦氏头皮针的运动区，这是应用最为广泛的治疗方法。然而，既往研究总结认为针刺治疗中风的临床疗效仍不明确。同时，尚未开展关于焦氏头皮针的随机对照试验。本研究旨在评估焦氏头皮针对缺血性中风运动功能障碍的疗效和安全性。
方法/设计：这是一项评估者和分析者双盲的随机对照试验。108例符合纳入标准的有运动功能障碍的中风患者将按1:1的比例随机分为针刺治疗组和对照组。对照组的中风患者将接受传统康复治疗，而针刺组将采用焦氏头皮针结合传统康复治疗。在8周内进行40次治疗。Fugl-Meyer评估量表将作为主要结局指标进行评估。改良Barthel指数、中风特异性生活质量量表和中医中风证候量表将作为次要结局指标。所有评估将在基线、第4周（治疗20次）、第8周（治疗40次）、第12周（随访）和第16周（随访）进行。
讨论
这是第一项评估焦氏头皮针对缺血性中风运动功能障碍的疗效和安全性的试验。预计本试验结果将提供相关证据，证明焦氏头皮针可作为改善缺血性中风运动功能障碍的一种有效的康复治疗方法。
试验注册
ClinicalTrials.gov，NCT02871453。于2016年7月17日注册。
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