Fang Qinqin, Xie Jing, Zheng Shiyu, Hou Yuchao, Wu Mengdie, Chen Yijing, Yang Yuechang, Wang Gengqi, Li Jing
Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Department of Anesthesiology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
J Pain Res. 2025 Jun 28;18:3289-3297. doi: 10.2147/JPR.S511236. eCollection 2025.
Electroacupuncture is effective in treating perioperative neurocognitive disorder (PND) and has good application prospects in the prevention and treatment of PND. However, the mechanism of electroacupuncture treatment for PND is comparatively unexplored.
METHODS/DESIGN: This is a single-center clinical, prospective randomized controlled clinical trial protocol. 180 patients will be randomly divided into the treatment group and the control group in a ratio of 1:1. Both groups of subjects received routine care, while the treatment group will receive electroacupuncture treatment twice a day for 10 days. Acupoints will include Baihui (DU20), Shangxing (DU23), Yintang (EX-HN3), Meichong (BL3), Fengchi (GB20), Cuanzhu (BL2), Laogong (PC8), Hegu (LI4), and Zusanli (ST36). The primary outcome measure is the Mini-mental State Examination (MMSE). And the secondary outcome measures are the Confusion Assessment Method (CAM), Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), neuron-specific enolase (NSE), superoxide dismutase (SOD), central nervous system-specific protein (s100-β) in serum. The outcome measures will be evaluated at baseline, during treatment and 1 week after treatment. What's more, the incidence of non-delirium complications and mortality within 30 days will also be measured.
Results of this trial are expected to clarify the value of electroacupuncture performed on perioperative cognitive impairment in elderly patients undergoing hip surgery.
This trial has been approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (No.2024-037).
International Traditional Medicine Clinical Trial Registry, ITMCTR2024000298 (http://itmctr.ccebtcm.org.cn/), registered on 25 August, 2024. The trial will comply with the Declaration of Helsinki.
电针疗法在治疗围手术期神经认知障碍（PND）方面有效，在PND的防治中具有良好的应用前景。然而，电针治疗PND的机制尚有待深入研究。
方法/设计：这是一项单中心临床前瞻性随机对照临床试验方案。180例患者将按1:1的比例随机分为治疗组和对照组。两组受试者均接受常规护理，而治疗组将接受电针治疗，每天2次，共10天。穴位包括百会（DU20）、上星（DU23）、印堂（EX-HN3）、眉冲（BL3）、风池（GB20）、攒竹（BL2）、劳宫（PC8）、合谷（LI4）和足三里（ST36）。主要结局指标是简易精神状态检查表（MMSE）。次要结局指标包括意识模糊评估法（CAM）、视觉模拟量表（VAS）、匹兹堡睡眠质量指数（PSQI）、广泛性焦虑障碍量表（GAD-7）、患者健康问卷-9（PHQ-9）以及血清中的白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）、神经元特异性烯醇化酶（NSE）、超氧化物歧化酶（SOD）、中枢神经系统特异性蛋白（s100-β）。结局指标将在基线、治疗期间及治疗后1周进行评估。此外，还将测定30天内非谵妄并发症的发生率和死亡率。
本试验结果有望阐明电针疗法对老年髋关节手术患者围手术期认知障碍的治疗价值。
本试验已获得上海中医药大学附属岳阳中西医结合医院伦理委员会批准（编号：2024-037）。
国际传统医学临床试验注册中心，注册号ITMCTR2024000298（http://itmctr.ccebtcm.org.cn/），于2024年8月25日注册。本试验将遵循《赫尔辛基宣言》。
