Li Hao, Zhou Li, Zhang Xin, Wen Qian, Tian Li, Yang Han, Chen Xirong, Yuan Jinghan, Li Ning, Zhu Bingmei, Zhang Lin, Lu Lingyun
Division of internal Medicine, Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Division of internal Medicine, Institute of Integrated Traditional Chinese and Western Medicine, Regenerative Medicine Research Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
BMC Complement Med Ther. 2024 Dec 28;24(1):428. doi: 10.1186/s12906-024-04723-8.
Sarcopenia is a disease primarily characterized by age-related loss of skeletal muscle mass, muscle strength, and/or decline in physical performance. Sarcopenia has an insidious onset which can cause functional impairment in the body and increase the risk of falls and disability in the elderly. It significantly increases the likelihood of fractures and mortality, severely impairing the quality of life and health of the elderly people. This disease poses a heavy burden on the healthcare system and society in our country, and currently, there are limited clinical intervention strategies for sarcopenia. This study aims to explore the clinical efficacy and safety of electroacupuncture in treating sarcopenia.
In this parallel-design, randomized, sham-controlled trial, a total of 168 elderly sarcopenia patients will be randomly assigned in a 1:1 ratio to receive either electroacupuncture (EA) or sham electroacupuncture (sEA) treatment. The acupuncture points used in the study are Hegu (LI4), Shousanli (LI10), Quchi (LI11), Binao (LI14), Futu (ST32), Liangqiu (ST34), Zusanli (ST36), and Jiexi (ST41). The participants will receive EA or sEA treatment three times per week for eight weeks. The primary outcome measure is the change in grip strength (GS) of the patients after the eight-week treatment. The secondary outcome measures include the changes in grip strength at the fourth and twentieth weeks, changes in appendicular skeletal muscle mass index (ASMI), the Short Physical Performance Battery (SPPB) score, the physical activity level (PAL) assessed by the International Physical Activity Questionnaire (IPAQ), assessment of expectations regarding the efficacy of acupuncture, patient subjective evaluation of efficacy, and evaluation of blinding efficacy of acupuncture. All statistical analyses will be conducted according to the intention-to-treat principle and as per the study protocol.
This study protocol was reviewed and approved by the Institutional Review Board of West China Hospital of Sichuan University (permission number: 2023 - 525). The participants will provide written informed consent to participate in this study.
Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), Registration number: ChiCTR2300079294. Date of Registration: 2023-12-29.
肌少症是一种主要以与年龄相关的骨骼肌质量丢失、肌肉力量下降和/或身体机能衰退为特征的疾病。肌少症起病隐匿，可导致身体功能受损，并增加老年人跌倒和残疾的风险。它显著增加了骨折和死亡率的可能性，严重损害了老年人的生活质量和健康。这种疾病给我国的医疗保健系统和社会带来了沉重负担，目前，针对肌少症的临床干预策略有限。本研究旨在探讨电针治疗肌少症的临床疗效和安全性。
在这项平行设计、随机、假对照试验中，总共168例老年肌少症患者将按1:1的比例随机分配，接受电针（EA）或假电针（sEA）治疗。本研究中使用的穴位为合谷（LI4）、手三里（LI10）、曲池（LI11）、臂臑（LI14）、伏兔（ST32）、梁丘（ST34）、足三里（ST36）和解溪（ST41）。参与者将每周接受3次EA或sEA治疗，共8周。主要结局指标是8周治疗后患者握力（GS）的变化。次要结局指标包括第4周和第20周握力的变化、四肢骨骼肌质量指数（ASMI）的变化、简短体能状况量表（SPPB）评分、通过国际体力活动问卷（IPAQ）评估的体力活动水平（PAL）、对针灸疗效的期望评估、患者对疗效的主观评价以及针灸盲法疗效评估。所有统计分析将根据意向性分析原则并按照研究方案进行。
本研究方案已通过四川大学华西医院伦理委员会审查并批准（批准号：2023 - 525）。参与者将提供书面知情同意书以参与本研究。
中国临床试验注册中心（http://www.chictr.org.cn），注册号：ChiCTR2300079294。注册日期：2023年12月29日。
