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Journal of Integrative Medicine: 2019   Online First

DOI: 10.1016/j.joim.2019.03.002
Study Protocol
Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial
1. Xin-yu Yue (School of Traditional Chinese Medicine, Naval Medical University, Shanghai 200082, China )
2. Zhuo-qi Feng (School of Traditional Chinese Medicine, Naval Medical University, Shanghai 200082, China )
3. Xi-yi Yu (School of Traditional Chinese Medicine, Naval Medical University, Shanghai 200082, China )
4. Jia-min Hu (School of Traditional Chinese Medicine, Naval Medical University, Shanghai 200082, China )
5. Xiao-jing He (Beijing He’s SanTong Acupuncture and Fire-needle Moxibustion Clinic, Beijing 100032, China )
6. Shi Shu (Basic Medical School, Shanghai University of Traditional Chinese Medicine; Shanghai 200082, China )

Abstract

Background

Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis (ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.

Methods/Design
A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients (n?=?120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group (FAG), filiform-needle acupuncture group (FFAG) and rehabilitation treatment group (RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5?d in a row and then rest for 2?d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.

Discussion
Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.

Trial registration
Chinese Clinical Trial Registry (identifier: ChiCTR-IOR-17013875; registration date: 28 December 2016).

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Please cite this article as:
Yue XY, Feng ZQ, Yu XY, Hu JM, He XJ, Shu S. Fire-needle acupuncture for upper limb spastic paralysis after stroke: study protocol for a randomized controlled trial. J Integr Med. 2019; Epub ahead of print.
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