1Acupuncture & Tuina College, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075 Sichuan China

2Hainan Medical University, Haikou, 571199 Hainan China

3Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072 Sichuan China

4Chengdu Second People’s Hospital, Chengdu, 610017 Sichuan China

5North Sichuan Medical College, Nanchong, 637100 Sichuan China

6Henan Provincial People’s Hospital, Zhengzhou, 450003 Henan China

7Rehabilitation and Health Preservation College, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075 Sichuan China

Youping Hu, Email: ten.haey@mctudcpyh.

Abstract

Background

Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI).

Methods

A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations.

Discussion

This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173). Registered on July 11, 2018.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05332-3.

Keywords: Chronic insomnia disorder, Gastrointestinal disorder, Multimodal magnetic resonance imaging, Acupuncture