Guo Shiqi, Dai Xiaoqian, Chen Xueming, Zhao Guozhen, Xue Ying, Zhang Chunhui, Liu Jinyi, Ouyang Xiali, Li Zhili, Shi Yuqing, Yao Qin, Han Li, Li Bo, Zhao Baixiao
Department of School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine Beijing 100700, China.
China Astronaut Research and Training Center Beijing 100094, China.
Am J Transl Res. 2022 Nov 15;14(11):8191-8203. eCollection 2022.
The aim for this trial was to preliminarily evaluate the effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) for bone loss in patients with immobilization after surgical fixation of ankle and foot fractures.
A total of 80 patients with immobilization after surgical fixation of ankle and foot fractures were randomly divided into an intervention group (n=40) or control group (n=40). The intervention group was given TEAS treatment combined with routine orthopedic treatment, and the control group was given only routine orthopedic treatment. The CT attenuation values, bone turnover markers (ALP, PINP, BGP, CTX, Ca/Cr), bone mineral density (BMD), blood phosphorus, and blood calcium were observed and compared between the two groups at 8 weeks. This was a prospective study. The protocol was registered in the Chinese clinical trial registry (No. ChiCTR2000039944).
The CT attenuation values of the intervention group decreased more than those of the control group (<0.05), however the between group differences in ALP, BGP, Ca/Cr, CTX and BMD (all >0.05) were not statistically significant. Three mild adverse events were recorded.
TEAS treatment may confer additional benefits for bone loss in patients with immobilization after surgical fixation of ankle and foot fractures. Since this was a pilot study, the efficacy of TEAS requires further evaluation through full-scale randomized controlled trials.
本试验旨在初步评估经皮穴位电刺激(TEAS)对踝足部骨折手术固定后制动患者骨质流失的有效性和安全性。
将80例踝足部骨折手术固定后制动的患者随机分为干预组(n = 40)和对照组(n = 40)。干预组给予TEAS治疗联合骨科常规治疗,对照组仅给予骨科常规治疗。观察并比较两组在8周时的CT衰减值、骨转换标志物(碱性磷酸酶、I型前胶原氨基端前肽、骨钙素、I型胶原交联C端肽、尿钙/肌酐)、骨密度、血磷和血钙。这是一项前瞻性研究。该方案已在中国临床试验注册中心注册(注册号:ChiCTR2000039944)。
干预组的CT衰减值下降幅度大于对照组(P<0.05),然而,两组间碱性磷酸酶、骨钙素、尿钙/肌酐、I型胶原交联C端肽和骨密度的差异均无统计学意义(均P>0.05)。记录到3例轻度不良事件。
TEAS治疗可能对踝足部骨折手术固定后制动患者的骨质流失有额外益处。由于这是一项初步研究,TEAS的疗效需要通过大规模随机对照试验进一步评估。