The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial
Open Access
- 7 June 2021
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 22 (1), 1-11
- https://doi.org/10.1186/s13063-021-05332-3
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.Funding Information
- Sichuan Province Science and Technology Support Program (2018JY0249)
This publication has 69 references indexed in Scilit:
- Altered Hub Configurations within Default Mode Network following Acupuncture at ST36: A Multimodal Investigation Combining fMRI and MEGPLOS ONE, 2013
- InsomniaJAMA, 2013
- Effect of Acupuncture in Mild Cognitive Impairment and Alzheimer Disease: A Functional MRI StudyPLOS ONE, 2012
- Cortical GABA Levels in Primary InsomniaSleep, 2012
- Acupuncture for Treatment of Insomnia in Patients With Traumatic Brain InjuryJournal of Head Trauma Rehabilitation, 2012
- Nighttime Insomnia Symptoms and Perceived Health in the America Insomnia Survey (AIS)Sleep, 2011
- Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (Stricta): Extending the Consort StatementAcupuncture in Medicine, 2010
- The shape of motor resonance: Right- or left-handed?NeuroImage, 2010
- The salient characteristics of the central effects of acupuncture needling: Limbic‐paralimbic‐neocortical network modulationHuman Brain Mapping, 2008
- Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: A six-country studyHealth and Quality of Life Outcomes, 2008