Fu Qin-hui, Pei Jian, Jia Qi, Song Yi, Gu Yue-hua, You Xiao-xin
Department of Acupuncture and Moxibustion, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Zhong Xi Yi Jie He Xue Bao. 2012 May;10(5):516-24. doi: 10.3736/jcim20120506.
Stroke is responsible for increasingly high rates of mortality and disability worldwide. Approximately two million people suffer from stroke for the first time in China each year. The high incidence (50%) of post-stroke disability brings a heavy burden to patients and their caregivers. Acupuncture has been widely used in the communities for post-stroke rehabilitation in China. The objective of this trial is to apply our acupuncture research achievement to treatment and evaluation of post-stroke hemiplegic patients in community.
A multicenter, randomized, controlled trial will be performed in Longhua Hospital and a number of community health service centers in Shanghai. A total of 124 patients (estimated sample size) with post-stroke hemiplegia will be randomly divided into an acupuncture group and a control group. The patients undergoing randomization should be stratified according to National Institutes of Health Stroke Scale score at baseline. Within the acupuncture group, different acupuncture protocols are administered to patients with flaccid paralysis or spastic paralysis based on the Ashworth Scale. Patients in the acupuncture group will also be treated with comprehensive rehabilitation therapy. The control group will be treated with comprehensive rehabilitation therapy only. The primary outcome measures are the Simplified Fugl-Meyer Motor Scale, the Modified Barthel Index, and the Burden of Stroke Scale. Secondary outcome measures are the modified Rankin Scale, the modified Ashworth Scale and the Stroke Scale of Traditional Chinese Medicine. Outcome measures will be performed after 4 and 8 weeks of treatment. The patients will be followed up after 6 months.
The results of this study are expected to demonstrate that our standardized acupuncture protocol for treating and evaluating post-stroke hemiplegic patients will improve motor function and lessen the burden of post-stroke patients within the communities. This will provide the evidence to support successful translation of acupuncture therapy for post-stroke hemiplegic patients in community hospital use.
This trial was registered in Chinese Clinical Trial Registry with the registration number ChiCTR-TRC-11001347.
在全球范围内，中风导致的死亡率和残疾率日益升高。中国每年约有200万人首次发生中风。中风后残疾的高发生率（50%）给患者及其照料者带来了沉重负担。在中国，针灸已在社区中广泛用于中风后的康复治疗。本试验的目的是将我们的针灸研究成果应用于社区中风偏瘫患者的治疗和评估。
将在上海龙华医院和多家社区卫生服务中心进行一项多中心、随机、对照试验。总共124例（估计样本量）中风偏瘫患者将被随机分为针灸组和对照组。进行随机分组的患者应根据基线时的美国国立卫生研究院卒中量表评分进行分层。在针灸组中，根据Ashworth量表，对弛缓性麻痹或痉挛性麻痹患者采用不同的针灸方案。针灸组的患者还将接受综合康复治疗。对照组仅接受综合康复治疗。主要结局指标为简化Fugl-Meyer运动量表、改良Barthel指数和卒中负担量表。次要结局指标为改良Rankin量表、改良Ashworth量表和中医卒中量表。在治疗4周和8周后进行结局指标评估。患者将在6个月后进行随访。
本研究结果有望表明，我们用于治疗和评估中风偏瘫患者的标准化针灸方案将改善社区中风患者的运动功能并减轻其负担。这将为支持针灸疗法在社区医院成功应用于中风偏瘫患者提供证据。
本试验已在中国临床试验注册中心注册，注册号为ChiCTR-TRC-11001347。
