The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial
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 in...
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doaj-b1c376bf54d84240956aa40eda260db32021-06-13T11:36:09ZengBMCTrials1745-62152021-06-0122111110.1186/s13063-021-05332-3The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trialWei Peng0Xiaojuan Hong1Yaru Huangfu2Zhao Sun3Wei Shen4Fen Feng5Liang Gong6Zhifu Shen7Baojun Guo8Leixiao Zhang9Yanan Wang10Ying Zhao11Tianmin Zhu12Youping Hu13Siyi Yu14Acupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineHainan Medical UniversityHainan Medical UniversityAffiliated Hospital of Chengdu University of Traditional Chinese MedicineChengdu Second People’s HospitalNorth Sichuan Medical CollegeHenan Provincial People’s HospitalAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineRehabilitation and Health Preservation College, Chengdu University of Traditional Chinese MedicineAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineAcupuncture & Tuina College, Chengdu University of Traditional Chinese MedicineAbstract 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.https://doi.org/10.1186/s13063-021-05332-3Chronic insomnia disorderGastrointestinal disorderMultimodal magnetic resonance imagingAcupuncture |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Wei Peng Xiaojuan Hong Yaru Huangfu Zhao Sun Wei Shen Fen Feng Liang Gong Zhifu Shen Baojun Guo Leixiao Zhang Yanan Wang Ying Zhao Tianmin Zhu Youping Hu Siyi Yu |
spellingShingle |
Wei Peng Xiaojuan Hong Yaru Huangfu Zhao Sun Wei Shen Fen Feng Liang Gong Zhifu Shen Baojun Guo Leixiao Zhang Yanan Wang Ying Zhao Tianmin Zhu Youping Hu Siyi Yu The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial Trials Chronic insomnia disorder Gastrointestinal disorder Multimodal magnetic resonance imaging Acupuncture |
author_facet |
Wei Peng Xiaojuan Hong Yaru Huangfu Zhao Sun Wei Shen Fen Feng Liang Gong Zhifu Shen Baojun Guo Leixiao Zhang Yanan Wang Ying Zhao Tianmin Zhu Youping Hu Siyi Yu |
author_sort |
Wei Peng |
title |
The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial |
title_short |
The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial |
title_full |
The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial |
title_fullStr |
The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial |
title_full_unstemmed |
The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial |
title_sort |
cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-06-01 |
description |
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. |
topic |
Chronic insomnia disorder Gastrointestinal disorder Multimodal magnetic resonance imaging Acupuncture |
url |
https://doi.org/10.1186/s13063-021-05332-3 |
work_keys_str_mv |
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