Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China.
Clinical Research Center for Acupuncture and Moxibustion in Sichuan Province, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China.
Trials. 2022 Jul 19;23(1):574. doi: 10.1186/s13063-022-06510-7.
Migraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA).
METHODS/DESIGN: This is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up.
In this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial.
The trial has been registered in the Chinese Clinical Trial Registry (approval no. ChiCTR2000032308 ) in April 2020.
偏头痛是一种常见的神经系统疾病。它是全球第三大常见疾病，第七大导致残疾的原因。针灸可能是一种可行的预防性偏头痛治疗选择。比较针灸和假针灸的临床研究尚未得出一致结论，无法确定针灸是否对偏头痛预防性治疗有效。针灸的效果主要取决于穴位和针的操作。我们发现，以前研究中的假针灸安慰剂设计包括在假穴位进行浅针刺、在假穴位进行非穿透性针刺以及在非活性穴位进行针刺以达到对照组的惰性效果，但忽略了在真穴位进行非穿透性针刺。本随机对照试验旨在使用真穴位进行非穿透性针刺作为对照，评估手动针刺对无先兆偏头痛（MWoA）的预防性作用。
方法/设计：这是一项单盲、随机、对照、前瞻性、多中心试验，设有两个平行治疗组。共纳入 198 例符合条件的 MWoA 患者，随机分为两组（1:1 分配比例）。干预组接受手动针刺，对照组接受安慰剂针刺（非穿透性）。患者每周接受 3 次针刺治疗，连续 4 周。所有患者将随后接受 12 周的随访。
在这项研究中，我们评估了手动针刺预防 MWoA 的疗效和安全性。安慰剂对照采用非穿透性真穴位针刺。确定适当的对照方法对于确保随机对照试验的方法学质量至关重要。
该试验于 2020 年 4 月在中国临床试验注册中心（注册号：ChiCTR2000032308）注册。
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