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Efficacy and safety of acupuncture for post-stroke spasticity: a study protocol for a randomized controlled trial
Zhihao Xiong1, Juwei Dong1, Yingying Zhu1
1Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Background:
Post-stroke spasticity (PSS) is a common motor complication during stroke recovery, imposing a substantial burden on both individuals and society owing to its high morbidity and disability rates. Current evidence suggests that acupuncture may be an effective intervention for alleviating PSS; however, the efficacy and safety remain uncertain owing to methodological limitations and the generally low quality of the existing evidence. Therefore, this study aims to evaluate the efficacy, feasibility, and safety of acupuncture for PSS and to explore the underlying anti-spasticity mechanisms.
Methods:
This study is a prospective, randomized, controlled trial. A total of 180 patients diagnosed with post-stroke spasticity (PSS) will be enrolled and randomly assigned in a 1:1:1 ratio to one of the three groups: acupuncture, sham acupuncture, or the basic treatment group. Participants in the acupuncture and sham acupuncture groups will receive a 4-week intervention, followed by a 4-week follow-up period. In contrast, the basic treatment group will receive only conventional medical management and standardized rehabilitation training without any acupuncture-related procedures. The primary outcome measure will be spasticity severity, assessed using the Modified Ashworth Scale (MAS). The secondary outcomes will include motor function (Fugl-Meyer Assessment, FMA), clinical spasticity (Clinical Spasticity Index, CSI), neurological impairment (National Institutes of Health Stroke Scale, NIHSS), activities of daily living (Modified Barthel Index, MBI), neuromuscular activity (surface electromyography, sEMG), and muscle mechanical properties (ultrasonographic elastography, UE). The FMA, CSI, NIHSS, and MBI will be evaluated at baseline, week 2, week 4 (end of treatment), and the 4-week follow-up visit. The MAS, sEMG, and UE will be assessed at baseline and at the end of the 4-week treatment period.
Discussion:
The results of this trial will help to clarify the preliminary efficacy, clinical feasibility, and safety of acupuncture for PSS patients and explore the anti-spastic mechanisms of acupuncture.
Clinical Trial Registration:
https://itmctr.ccebtcm.org.cn/mgt/project/view/1963190034123325440, ITMCTR2025001662.
