针刺结合语言训练治疗中风后运动性失语症的疗效和安全性：一项多中心随机假针刺对照试验的研究方案。

The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial.

机构信息

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.

National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.

出版信息

Trials. 2022 Jun 30;23(1):540. doi: 10.1186/s13063-022-06280-2.

DOI:10.1186/s13063-022-06280-2

PMID:35773693

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9245218/

Abstract

BACKGROUND

Motor aphasia after stroke is a common and intractable complication of stroke. Acupuncture and language training may be an alternative and effective approach. However, the efficacy of acupuncture and language training for motor aphasia after stroke has not been confirmed. The main objectives of this trial are to evaluate the effectiveness and safety of acupuncture and low-intensity, low-dose language training in treating ischemic motor aphasia after stroke from 15 to 90 days.

METHODS

This is a multicenter randomized sham-controlled clinical trial. We will allocate 252 subjects aged between 45 and 75 years diagnosed with motor aphasia after stroke with an onset time ranging from 15 to 90 days into two groups randomly in a 1:1 ratio. Patients in the experimental group will be treated with "Xing-Nao Kai-Qiao" acupuncture therapy plus language training, and those in the control group will be treated with sham-acupoint (1 cun next to the acupoints) acupuncture therapy plus language training. All the patients will be given acupuncture and language training for 6 weeks, with a follow-up evaluation 6 weeks after the end of the treatment and 6 months after the onset time. The patients will mainly be evaluated using the Western Aphasia Battery and Chinese Functional Communication Profile, and the incidence of treatment-related adverse events at the 2nd, 4th, and 6th weeks of treatment will be recorded. The baseline characteristics of the patients will be summarized by group, the chi-squared test will be used to compare categorical variables, and repeated measures of analysis of variance or a linear mixed model will be applied to analyze the changes measured at different time points.

DISCUSSION

The present study is designed to investigate the effectiveness and safety of traditional acupuncture therapy and language training in ischemic motor aphasia after stroke and explore the correlation between the treatment time and clinical effect of acupuncture. We hope our results will help doctors understand and utilize acupuncture combined with language training.

TRIAL REGISTRATION

ChiCTR ChiCTR1900026740 . Registered on 20 October 2019.

摘要

背景

脑卒中后运动性失语是脑卒中常见且难以治疗的并发症。针刺和语言训练可能是一种替代且有效的方法。然而，针刺和语言训练治疗脑卒中后运动性失语的疗效尚未得到证实。本试验的主要目的是评估针刺和低强度、低剂量语言训练治疗脑卒中后 15-90 天缺血性运动性失语的有效性和安全性。

方法

这是一项多中心随机假对照临床试验。我们将把 252 名年龄在 45-75 岁之间、脑卒中后被诊断为运动性失语且发病时间在 15-90 天的患者随机分为两组，每组 126 人，比例为 1:1。实验组患者接受“醒脑开窍”针刺疗法加语言训练，对照组患者接受假穴位（穴位旁 1 寸）针刺疗法加语言训练。所有患者均接受针刺和语言训练 6 周，治疗结束后 6 周和发病后 6 个月进行随访评估。患者主要采用西方失语症成套测验和汉语功能沟通量表进行评估，并记录治疗相关不良事件的发生率在治疗第 2、4、6 周。通过组间比较总结患者的基线特征，采用卡方检验比较分类变量，采用重复测量方差分析或线性混合模型分析不同时间点的测量变化。