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Open Access 01-12-2022 | Acupuncture | Study protocol

Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial

Authors: Jiao Chen, Siyuan Zhou, Mingsheng Sun, Yanan Wang, Xiaoqin Chen, Taipin Guo, Lu Liu, Jing Luo, Xixiu Ni, Xuguang Yang, Dehua Li, Shan Gao, Zhenxi He, Dingjun Cai, Ling Zhao

Published in: Trials | Issue 1/2022

Abstract

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.

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Title: Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial
Authors: Jiao Chen
Siyuan Zhou
Mingsheng Sun
Yanan Wang
Xiaoqin Chen
Taipin Guo
Lu Liu
Jing Luo
Xixiu Ni
Xuguang Yang
Dehua Li
Shan Gao
Zhenxi He
Dingjun Cai
Ling Zhao
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Acupuncture
Migraine
Aura
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06510-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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