PMID- 35854329 OWN - NLM STAT- MEDLINE DCOM- 20220721 LR - 20220724 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 23 IP - 1 DP - 2022 Jul 19 TI - Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial. PG - 574 LID - 10.1186/s13063-022-06510-7 [doi] LID - 574 AB - BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: The trial has been registered in the Chinese Clinical Trial Registry (approval no. ChiCTR2000032308 ) in April 2020. CI - (c) 2022. The Author(s). FAU - Chen, Jiao AU - Chen J AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. AD - Clinical Research Center for Acupuncture and Moxibustion in Sichuan Province, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Zhou, Siyuan AU - Zhou S AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. AD - Clinical Research Center for Acupuncture and Moxibustion in Sichuan Province, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Sun, Mingsheng AU - Sun M AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Wang, Yanan AU - Wang Y AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Chen, Xiaoqin AU - Chen X AD - Chengdu Pidu District Hospital of Traditional Chinese Medicine, No. 342, South Street, Pidu District, Chengdu, 610075, Sichuan, China. FAU - Guo, Taipin AU - Guo T AD - Acupuncture and Massage-Rehabilitation School, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Kunming, 650500, Yunnan, China. FAU - Liu, Lu AU - Liu L AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Luo, Jing AU - Luo J AD - Hospital (T. C. M) Affiliated to Southwest Medical University, No.182 Chunhui Road, Longmatan District, Luzhou City, 610075, Sichuan, China. FAU - Ni, Xixiu AU - Ni X AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Yang, Xuguang AU - Yang X AD - Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, No.63, Dongming Road, Zhengzhou, 450000, Henan, China. FAU - Li, Dehua AU - Li D AD - Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, No.39 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Gao, Shan AU - Gao S AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - He, Zhenxi AU - He Z AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Cai, Dingjun AU - Cai D AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. AD - Clinical Research Center for Acupuncture and Moxibustion in Sichuan Province, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. FAU - Zhao, Ling AU - Zhao L AUID- ORCID: 0000-0002-3955-0072 AD - Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. zhaoling@cdutcm.edu.cn. AD - Clinical Research Center for Acupuncture and Moxibustion in Sichuan Province, No.37 Shier Qiao Road, Chengdu, 610075, Sichuan, China. zhaoling@cdutcm.edu.cn. LA - eng GR - 2019YFC1709700/national key research and development project/ GR - 81973962/national natural science foundation of china/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20220719 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Acupuncture Points MH - *Acupuncture Therapy/adverse effects/methods MH - Humans MH - *Migraine without Aura/etiology MH - Multicenter Studies as Topic MH - Prospective Studies MH - Randomized Controlled Trials as Topic MH - Treatment Outcome PMC - PMC9295267 OTO - NOTNLM OT - Clinical trial protocol OT - Migraine without aura OT - Randomized controlled trial COIS- The authors declare that they have no competing interests. EDAT- 2022/07/20 06:00 MHDA- 2022/07/22 06:00 PMCR- 2022/07/19 CRDT- 2022/07/19 23:48 PHST- 2021/07/15 00:00 [received] PHST- 2022/07/05 00:00 [accepted] PHST- 2022/07/19 23:48 [entrez] PHST- 2022/07/20 06:00 [pubmed] PHST- 2022/07/22 06:00 [medline] PHST- 2022/07/19 00:00 [pmc-release] AID - 10.1186/s13063-022-06510-7 [pii] AID - 6510 [pii] AID - 10.1186/s13063-022-06510-7 [doi] PST - epublish SO - Trials. 2022 Jul 19;23(1):574. doi: 10.1186/s13063-022-06510-7.