Li Yanpi, Fan Bifa, Wang Xiyun, Hu Naichong, Zhou Xinyi, Zhang Yi, Mao Peng, Li Yifan
Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Department of Pain Management, China-Japan Friendship Hospital, Beijing, People's Republic of China.
J Pain Res. 2025 May 24;18:2663-2677. doi: 10.2147/JPR.S523538. eCollection 2025.
Fibromyalgia Syndrome (FMS) is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, and localized tenderness. Transcutaneous Electrical Acustimulation (TEA) is a non-invasive therapy that combines Traditional Chinese Medicine with electrical stimulation at specific acupoints. Previous studies have shown that TEA is effective in treating pain-related conditions. This study aims to evaluate the efficacy and mechanisms of TEA treatment for FMS.
This is a prospective, randomized, double-blind, and placebo-controlled trial with two parallel groups, conducted at a single center. Forty participants will be randomly assigned to either the TEA group or the sham-TEA group in a 1:1 ratio. Participants will receive 2 weeks of treatment followed by 2 weeks of follow-up. The primary outcome is the change in VAS pain scores before and after treatment. Secondary outcomes include FMS and pain-related questionnaire scales, infrared thermography (IRT), vibration-controlled transient elastography (VCTE), blood neurobiological markers, cytokines, and metabolomics.
http://itmctr.ccebtcm.org.cn/ identifier ITMCTR2024000638.
纤维肌痛综合征（FMS）是一种慢性疾病，其特征为广泛的肌肉骨骼疼痛、疲劳和局部压痛。经皮电刺激疗法（TEA）是一种将中医与特定穴位的电刺激相结合的非侵入性疗法。先前的研究表明，TEA在治疗疼痛相关病症方面有效。本研究旨在评估TEA治疗FMS的疗效和机制。
这是一项在单一中心进行的前瞻性、随机、双盲、安慰剂对照试验，有两个平行组。40名参与者将按1:1的比例随机分配到TEA组或假TEA组。参与者将接受2周的治疗，随后进行2周的随访。主要结局是治疗前后视觉模拟评分（VAS）疼痛评分的变化。次要结局包括FMS和疼痛相关问卷量表、红外热成像（IRT）、振动控制瞬时弹性成像（VCTE）、血液神经生物学标志物、细胞因子和代谢组学。
http://itmctr.ccebtcm.org.cn/ 标识符ITMCTR2024000638。
