Afshari Fard Mohammad Reza, Mohammadi Ali, Ma Liang-Xiao, Mu Jie-Dan, Yu Wen-Yan, Song Yue, Wang Jun-Xiang, Gan Ying-Ying, Tian Yuan, Qian Xu, Sun Tian-Yi, Iravani Somayeh
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Medicine (Baltimore). 2020 Jan;99(3):e18847. doi: 10.1097/MD.0000000000018847.
Acupuncture has been widely used to treat primary dysmenorrhea (PD) with satisfactory outcomes. Sanyinjiao (SP6) is the most commonly used acupoint for PD. Different needling techniques may influence the effect of SP6, and its underlying mechanism needs to be explored. This randomized controlled parallel trial is designed to evaluate the immediate analgesic effect and hemodynamic responses in uterine arterial blood flow of perpendicular needling and transverse needling at SP6 in patients with PD of cold-dampness stagnation pattern using color doppler ultrasonography.
Forty-eight patients who meet inclusion criteria will be randomized in a ratio of 1:1 to either perpendicular needling or transverse needling groups. Every participant will receive 1 session of acupuncture treatment for 10 minutes at bilateral SP6. In the perpendicular needling group, needles will be inserted vertically 1 to 1.2 cun and will be manipulated to achieve needling sensation. In transverse needling group, the needles will be inserted transversely 1 to 1.2 cun toward the abdomen without any manipulation to avoid needling sensation. Color doppler ultrasonography will be performed before, during, and after needling. The primary outcome measure is visual analog scale for pain. The secondary outcome measures include the uterine artery blood flow changes by measuring pulsatility index, resistance index values, and ratio of systolic peak and diastolic peak, the Hamilton anxiety scale, blood pressure, and heart rate. Adverse events in both groups also will be recorded.
This trial will be the first study protocol designed to explore the influence of needling techniques on the analgesia effect of solo acupoint and its hemodynamic responses for PD. It will promote more widespread awareness of the benefits of using suitable needling techniques in acupuncture clinical setting and provide a further explanation of the underlying hemodynamic mechanism.
This study protocol was registered at the Chinese clinical trial registry (ChiCTR1900026051).
针灸已被广泛用于治疗原发性痛经（PD），疗效满意。三阴交（SP6）是治疗PD最常用的穴位。不同的针刺技术可能会影响SP6的疗效，其潜在机制有待探索。本随机对照平行试验旨在采用彩色多普勒超声评估寒湿凝滞型PD患者垂直针刺和横向针刺SP6后的即时镇痛效果及子宫动脉血流动力学反应。
48例符合纳入标准的患者将按1:1比例随机分为垂直针刺组或横向针刺组。每位参与者将在双侧SP6接受1次10分钟的针刺治疗。垂直针刺组，针垂直刺入1至1.2寸，并进行手法操作以获得针感。横向针刺组，针横向朝腹部刺入1至1.2寸，不进行任何手法操作以避免针感。针刺前、针刺期间和针刺后均进行彩色多普勒超声检查。主要结局指标是疼痛视觉模拟量表。次要结局指标包括通过测量搏动指数、阻力指数值以及收缩期峰值与舒张期峰值之比来评估子宫动脉血流变化、汉密尔顿焦虑量表、血压和心率。两组的不良事件也将被记录。
本试验将是首个旨在探索针刺技术对单一穴位镇痛效果及其对PD血流动力学反应影响的研究方案。它将提高人们对在针灸临床中使用合适针刺技术益处的更广泛认识，并为潜在的血流动力学机制提供进一步解释。
本研究方案已在中国临床试验注册中心注册（ChiCTR1900026051）。
