Lu Lingyun, Zheng Hui, Zheng Qianhua, Hao Xinyu, Zhou Siyuan, Zhang Shusen, Wei Tao, Gao Tao, Duan Duoxi, Zhao Ling, Li Ning, Li Ying
Chengdu University of Traditional Chinese Medicine, 37 Shi'er Qiao Road, Jinniu District, Chengdu, Sichuan, 610075, People's Republic of China.
West China School of Medicine/West China Hospital of Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 610041, People's Republic of China.
Trials. 2017 Oct 3;18(1):453. doi: 10.1186/s13063-017-2188-9.
The effectiveness of acupuncture for patients with chronic tension-type headache (CTTH) is controversial. In this article, we report the protocol for a randomized controlled trial aiming to evaluate the long-term effect of acupuncture for CTTH, in comparison with superficial acupuncture.
A two-armed, parallel-design, patient-assessor blind, randomized controlled trial is underway in China. A total of 218 participants with CTTH will be randomly assigned to the treatment group or the control group in a 1:1 ratio. Participants in the treatment group and control group will receive acupuncture or superficial acupuncture treatments in a fixed prescription of acupoints respectively, for a total of 20 sessions over 8 weeks. The posttreatment follow-up period will be 24 weeks. The primary outcome will be the proportion of responders assessed at week 16 after randomization. The secondary outcomes will include the number of headache days, the mean intensity of headache, the reduction of medication intake, results from the 36-item short form health survey, the Hamilton Depression Scale and the Hamilton Anxiety Scale, the number of participants with adverse events, the expectation value of acupuncture treatment, and the intensity of deqi sensation. The first five secondary outcomes will be assessed or calculated at baseline, and at 4, 8, 12, 16, 20, 24, 28, and 32 weeks after randomization. Moreover, the expectation value will be collected at baseline and at week 8 after randomization, the intensity of deqi sensation will be assessed at 5 minutes after each treatment and adverse events will be summarized at the end of the follow-up period.
Results from this trial will provide evidence for the long-term effect of acupuncture for CTTH with a long follow-up period.
ClinicalTrial.gov NCT03133884 . Registered on 25 April 2017.
针刺治疗慢性紧张型头痛（CTTH）患者的疗效存在争议。在本文中，我们报告一项随机对照试验方案，旨在评估针刺与浅刺相比治疗CTTH的长期效果。
一项双臂、平行设计、患者和评估者双盲的随机对照试验正在中国进行。总共218名CTTH患者将按1:1的比例随机分配到治疗组或对照组。治疗组和对照组的参与者将分别接受固定穴位处方的针刺或浅刺治疗，共8周20次。治疗后随访期为24周。主要结局将是随机分组后第16周评估的有反应者的比例。次要结局将包括头痛天数、头痛平均强度、药物摄入量减少情况、36项简短健康调查问卷结果、汉密尔顿抑郁量表和汉密尔顿焦虑量表结果、不良事件参与者数量、针刺治疗期望值以及得气感觉强度。前五个次要结局将在基线以及随机分组后第4、8、12、16、20、24、28和32周进行评估或计算。此外，期望值将在基线和随机分组后第8周收集，每次治疗后5分钟评估得气感觉强度，随访期结束时总结不良事件。
该试验结果将为针刺治疗CTTH的长期效果提供具有长期随访期的证据。
ClinicalTrial.gov NCT03133884。于2017年4月25日注册。
