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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

Authors: Jun Wang, Jian Pei, Dhiaedin Khiati, Qinhui Fu, Xiao Cui, Yi Song, Minghang Yan, Lijun Shi, Yiwen Cai, Yuhong Ma

Published in: Trials | Issue 1/2017

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Abstract

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.
Appendix
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Metadata
Title
Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial
Authors
Jun Wang
Jian Pei
Dhiaedin Khiati
Qinhui Fu
Xiao Cui
Yi Song
Minghang Yan
Lijun Shi
Yiwen Cai
Yuhong Ma
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2000-x

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