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Trials. 2017 Jun 20;18(1):287. doi: 10.1186/s13063-017-2000-x.

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

Author information

1
Department of Acupuncture, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South WanPing Road, XuHui District, Shanghai, 200032, China. 13512183795@163.com.
2
Department of Rehabilitation, Shanghai Changning District Tianshan Hospital of Traditional Chinese Medicine, No. 868 Loushanguan Road, Changning District, Shanghai, 20005l, China. 13512183795@163.com.
3
Department of Acupuncture, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South WanPing Road, XuHui District, Shanghai, 200032, China. jianpei99@yahoo.com.
4
School of Medicine, Royal College of Surgeons in Ireland - Medical University of Bahrain, 15503, Adilya, Bahrain.
5
Department of Acupuncture, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South WanPing Road, XuHui District, Shanghai, 200032, China.
6
Department of Rehabilitation, Shanghai Changning District Tianshan Hospital of Traditional Chinese Medicine, No. 868 Loushanguan Road, Changning District, Shanghai, 20005l, China.

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.

KEYWORDS:

Ischemic stroke; Jiao’s scalp acupuncture; Motor dysfunction; Study protocol

PMID:
28633675
PMCID:
PMC5479040
DOI:
10.1186/s13063-017-2000-x
[Indexed for MEDLINE]
Free PMC Article

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