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Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram
INTRODUCTION: Cerebral palsy is the most common motor disability of childhood. Spastic cerebral palsy accounts for 60% to 70% of cases. Research has shown that acupuncture can improve the quality of life of children with cerebral palsy, but the mechanism of action remains unclear. This study aims to...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386969/ https://www.ncbi.nlm.nih.gov/pubmed/32791681 http://dx.doi.org/10.1097/MD.0000000000021082 |
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author | Chen, Dong Bao, Chao Geng, Yan-Xia Yang, Ming Teo, Elsie Sin May Li, Jan-Bing Li, Yan-Cai Wang, Nan Yuan, Meng-Qian Zou, Qin Tang, Ping-Ping Zhu, Li-Li Xu, Bin |
author_facet | Chen, Dong Bao, Chao Geng, Yan-Xia Yang, Ming Teo, Elsie Sin May Li, Jan-Bing Li, Yan-Cai Wang, Nan Yuan, Meng-Qian Zou, Qin Tang, Ping-Ping Zhu, Li-Li Xu, Bin |
author_sort | Chen, Dong |
collection | PubMed |
description | INTRODUCTION: Cerebral palsy is the most common motor disability of childhood. Spastic cerebral palsy accounts for 60% to 70% of cases. Research has shown that acupuncture can improve the quality of life of children with cerebral palsy, but the mechanism of action remains unclear. This study aims to determine the effectiveness of acupuncture for treatment of children with spastic cerebral palsy and to assess the value of multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG) for evaluation of treatment effect. METHODS AND ANALYSIS: This randomized controlled trial will enroll a total of 72 children with CP from 2 hospitals—Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric—with 36 participants from each hospital. Patients will be randomly assigned (1:1 ratio) to receive “Tonifying Kidney and Invigorating Brain” acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group). All participants will receive 3 treatment sessions per week for 3 consecutive months; they will then be followed up for another 3 months. The primary outcome measures will include multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules. The secondary outcome measures will include Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score. Outcome measures (including primary and secondary outcome measures) were collected at the baseline, 3 months and 6 months prior to the intervention. Ethics and dissemination PATIENTS CONSENT: Obtained. ETHICS APPROVAL: The central independent ethics committee of Jiangsu Province Hospital of Traditional Chinese Medicine approved the protocol (2017NL-115-02). SAFETY CONSIDERATIONS: Routine blood tests and liver and kidney function tests will be conducted to exclude patients with severe heart, liver, or kidney diseases. The same examinations will be performed again at the end of the study to detect any possible side effects. Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented. Serious adverse events will be reported to the principal investigator immediately. All unexpected and unintended responses, even those not necessarily related to the acupuncture intervention, will be documented as adverse events. CASE DROPOUT MANAGEMENT: Participants have a right to withdraw from the study at any time if they feel uncomfortable upon receiving the treatments or being diagnosed with serious complications or diseases. They will then be referred to the preferred department for further treatment and management. If cases of dropout, the researcher need to contact the participant to reason the problem out, collect and record all the necessary assessments on the last visit as well as the date of last visit. All data available until the date of withdrawal will be stored for further statistical analysis. DISCUSSION: This research is being conducted to assess the value of acupuncture as an intervention for rehabilitation of children with spastic cerebral palsy and also to evaluate the usefulness of multimodal MRI and ambulatory EEG for identifying changes in brain function. TRIAL REGISTRATION: This trial is registered with Chinese Clinical Trials Register, ChiCTR 1900024546 (registered 15 July 2019; retrospective registration, http://www.chictr.org.cn/showproj.aspx?proj=35763). |
format | Online Article Text |
id | pubmed-7386969 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-73869692020-08-05 Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram Chen, Dong Bao, Chao Geng, Yan-Xia Yang, Ming Teo, Elsie Sin May Li, Jan-Bing Li, Yan-Cai Wang, Nan Yuan, Meng-Qian Zou, Qin Tang, Ping-Ping Zhu, Li-Li Xu, Bin Medicine (Baltimore) 3800 INTRODUCTION: Cerebral palsy is the most common motor disability of childhood. Spastic cerebral palsy accounts for 60% to 70% of cases. Research has shown that acupuncture can improve the quality of life of children with cerebral palsy, but the mechanism of action remains unclear. This study aims to determine the effectiveness of acupuncture for treatment of children with spastic cerebral palsy and to assess the value of multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG) for evaluation of treatment effect. METHODS AND ANALYSIS: This randomized controlled trial will enroll a total of 72 children with CP from 2 hospitals—Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric—with 36 participants from each hospital. Patients will be randomly assigned (1:1 ratio) to receive “Tonifying Kidney and Invigorating Brain” acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group). All participants will receive 3 treatment sessions per week for 3 consecutive months; they will then be followed up for another 3 months. The primary outcome measures will include multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules. The secondary outcome measures will include Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score. Outcome measures (including primary and secondary outcome measures) were collected at the baseline, 3 months and 6 months prior to the intervention. Ethics and dissemination PATIENTS CONSENT: Obtained. ETHICS APPROVAL: The central independent ethics committee of Jiangsu Province Hospital of Traditional Chinese Medicine approved the protocol (2017NL-115-02). SAFETY CONSIDERATIONS: Routine blood tests and liver and kidney function tests will be conducted to exclude patients with severe heart, liver, or kidney diseases. The same examinations will be performed again at the end of the study to detect any possible side effects. Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented. Serious adverse events will be reported to the principal investigator immediately. All unexpected and unintended responses, even those not necessarily related to the acupuncture intervention, will be documented as adverse events. CASE DROPOUT MANAGEMENT: Participants have a right to withdraw from the study at any time if they feel uncomfortable upon receiving the treatments or being diagnosed with serious complications or diseases. They will then be referred to the preferred department for further treatment and management. If cases of dropout, the researcher need to contact the participant to reason the problem out, collect and record all the necessary assessments on the last visit as well as the date of last visit. All data available until the date of withdrawal will be stored for further statistical analysis. DISCUSSION: This research is being conducted to assess the value of acupuncture as an intervention for rehabilitation of children with spastic cerebral palsy and also to evaluate the usefulness of multimodal MRI and ambulatory EEG for identifying changes in brain function. TRIAL REGISTRATION: This trial is registered with Chinese Clinical Trials Register, ChiCTR 1900024546 (registered 15 July 2019; retrospective registration, http://www.chictr.org.cn/showproj.aspx?proj=35763). Wolters Kluwer Health 2020-07-24 /pmc/articles/PMC7386969/ /pubmed/32791681 http://dx.doi.org/10.1097/MD.0000000000021082 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | 3800 Chen, Dong Bao, Chao Geng, Yan-Xia Yang, Ming Teo, Elsie Sin May Li, Jan-Bing Li, Yan-Cai Wang, Nan Yuan, Meng-Qian Zou, Qin Tang, Ping-Ping Zhu, Li-Li Xu, Bin Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram |
title | Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram |
title_full | Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram |
title_fullStr | Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram |
title_full_unstemmed | Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram |
title_short | Effect of “Tonifying Kidney and Invigorating Brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram |
title_sort | effect of “tonifying kidney and invigorating brain” acupuncture in children with spastic cerebral palsy analyzed by multi-modality mri combined with dynamic electroencephalogram |
topic | 3800 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386969/ https://www.ncbi.nlm.nih.gov/pubmed/32791681 http://dx.doi.org/10.1097/MD.0000000000021082 |
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