Central Mechanism of Acupuncture Treatment in Patients with Migraine: Study Protocol for Randomized Controlled Neuroimaging Trial

Abstract

Purpose

Acupuncture has been recognized as an effective and safe alternative therapy for migraine, but its central mechanism has not yet been adequately explained. Meanwhile, research into the clinical efficacy and central mechanism of true acupuncture (TA) and sham acupuncture (SA) is lacking. It is necessary to investigate whether TA has better efficacy than SA, and how they achieve different effects. This study aims to evaluate the efficacy of TA and SA, observe the brain response caused by TA and SA, and further investigate the central nervous mechanism of TA and SA treatment for patients with migraine.

Patients and Methods

This is a randomized controlled neuroimaging trial combining acupuncture treatment with functional magnetic resonance imaging, with patients and outcome assessors blinded. A total of 60 patients with migraine will be randomly allocated to receive 12 sessions of either TA or SA treatments (three sessions per week for 4 weeks), and 30 healthy participants will be recruited as the healthy control (HC) group. Outcome assessment and neuroimaging will be conducted before and after the entire intervention. A headache diary and questionnaires of life quality and psychological properties will be used to evaluate clinical efficacy. Multimodal magnetic resonance imagining data analysis will be used to investigate the central mechanism of TA or SA in treating migraine. Pearson’s correlation analysis will be used to reveal the relationship between the brain response and clinical improvements.

Conclusion

The results of this study will reveal the brain response to TA and SA in patients with migraine and contribute to further expanding the knowledge of their central mechanism.

Study Registration

This trial has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2020-38) and registered in the Chinese Clinical Trial Registry (registration number ChiCTR2000033995).

Keywords:

• migraine
• acupuncture
• functional magnetic resonance imaging
• protocol

Abbreviations

AE, adverse event; BOLD, blood oxygen level dependent; CONSORT, Consolidated Standards of Reporting Trials; CRF, case report form; DPARSF, Data Processing Assistant and Resting-State fMRI; DTI, diffusion tensor imaging; EPI, echo planar imaging; FA, flip angle; fMRI, functional magnetic resonance imaging; HC, healthy control; HIS, International Headache Society; MRI, magnetic resonance imaging; MwoA, migraine without aura; NPSA, nonpenetrative sham acupuncture; PSA, penetrative sham acupuncture; SA, sham acupuncture; SPIRIT, Standard Protocol Items: Recommendations for Intervention Trials; TA, true acupuncture; TCM, traditional Chinese medicine; TE, echo time; TR, repetition time; WHO, World Health Organization; 3D-T1WI, three-dimensional T1-weighted imaging.

Data Sharing Statement

The datasets analyzed during this study will be available from the corresponding author on reasonable request after they have been published in a peer-reviewed international journal.

Ethics and Dissemination

This trial has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2020-38). The results of this trial will be disseminated through peer-reviewed publications and scientific conferences.

Acknowledgments

The authors sincerely thank all medical workers on the front line for fighting the COVID-19 epidemic.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. Among them, JNJ contributed most to this work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This study was supported by grants from the National Natural Science Foundation of China Youth Fund (82004197) and Project for New Teachers of Beijing University of Chinese Medicine (2020-JYB-XJSJJ-045).