Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial

Abstract Background Painful diabetic peripheral neuropathy (PDPN) has a great impact on an individual’s quality of life. The current researchers’ previous trial suggested that acupuncture was a promising adjunctive treatment for PDPN. However, the underlying mechanism of action of acupuncture treatm...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Mengyuan Li, Lin Yao, Haipeng Huang, Liying Zhang, Haizhu Zheng, Guan Wang, Zhen Zhong, Shiqi Ma, Shuo Yu, Hongfeng Wang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Electropuncture Painful diabetic peripheral neuropathy Central sensitization of the brain Functional magnetic resonance imaging; Clinical trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/9f2ab07becce4da88f2834d54b6e7a3a
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:9f2ab07becce4da88f2834d54b6e7a3a
record_format	dspace
spelling	oai:doaj.org-article:9f2ab07becce4da88f2834d54b6e7a3a2021-11-14T12:31:18ZMultimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial10.1186/s13063-021-05773-w1745-6215https://doaj.org/article/9f2ab07becce4da88f2834d54b6e7a3a2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05773-whttps://doaj.org/toc/1745-6215Abstract Background Painful diabetic peripheral neuropathy (PDPN) has a great impact on an individual’s quality of life. The current researchers’ previous trial suggested that acupuncture was a promising adjunctive treatment for PDPN. However, the underlying mechanism of action of acupuncture treatment for PDPN is still unclear, especially its effects at the cerebral level. The aim of this trial will be to explore how acupuncture works in treating PDPN by using multimodal cerebral imaging. Method and design This will be a randomized controlled trial. A total of 150 participants will be recruited and assigned to one of three groups: the healthy group, the DM without PDPN group and the DM with PDPN group. Participants in the DM without PDPN and the DM with PDPN groups will each be further divided between an electroacupuncture group and a sham electroacupuncture group. Participants will receive six treatment sessions per week for 4 weeks. Multimodal cerebral imaging includes resting-state functional magnetic resonance imaging (rs-fMRI), diffusion tensor imaging (DTI) and magnetic resonance spectroscopy (MRS); this neurophysiological testing will be the primary outcome measure. Subjective pain scales and blood analysis will be a secondary outcome measure and will be used to assess the clinical efficacy of the intervention. Multimodal cerebral imaging will be used to detect cerebral activity changes in each treatment group. The clinical data and fMRI data will be analysed for all the groups. Multiple correlation regression analyses will be used to assess the association between changes in cerebral functional activity and the improvement of clinical outcomes after acupuncture treatment. Discussion This study is based on the results of the researchers’ previous study, and using combined clinical and cerebral function changes, it will help evaluate the effects of acupuncture on PDPN. The investigation of acupuncture’s central mechanism of action will further expand the understanding of acupuncture treatment of PDPN. Trial registration Chinese Clinical Trial Registry ChiCTR1900024109 . Registered on 26 June 2019.Mengyuan LiLin YaoHaipeng HuangLiying ZhangHaizhu ZhengGuan WangZhen ZhongShiqi MaShuo YuHongfeng WangBMCarticleElectropuncturePainful diabetic peripheral neuropathyCentral sensitization of the brainFunctional magnetic resonance imaging; Clinical trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Electropuncture Painful diabetic peripheral neuropathy Central sensitization of the brain Functional magnetic resonance imaging; Clinical trial Medicine (General) R5-920
spellingShingle	Electropuncture Painful diabetic peripheral neuropathy Central sensitization of the brain Functional magnetic resonance imaging; Clinical trial Medicine (General) R5-920 Mengyuan Li Lin Yao Haipeng Huang Liying Zhang Haizhu Zheng Guan Wang Zhen Zhong Shiqi Ma Shuo Yu Hongfeng Wang Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial
description	Abstract Background Painful diabetic peripheral neuropathy (PDPN) has a great impact on an individual’s quality of life. The current researchers’ previous trial suggested that acupuncture was a promising adjunctive treatment for PDPN. However, the underlying mechanism of action of acupuncture treatment for PDPN is still unclear, especially its effects at the cerebral level. The aim of this trial will be to explore how acupuncture works in treating PDPN by using multimodal cerebral imaging. Method and design This will be a randomized controlled trial. A total of 150 participants will be recruited and assigned to one of three groups: the healthy group, the DM without PDPN group and the DM with PDPN group. Participants in the DM without PDPN and the DM with PDPN groups will each be further divided between an electroacupuncture group and a sham electroacupuncture group. Participants will receive six treatment sessions per week for 4 weeks. Multimodal cerebral imaging includes resting-state functional magnetic resonance imaging (rs-fMRI), diffusion tensor imaging (DTI) and magnetic resonance spectroscopy (MRS); this neurophysiological testing will be the primary outcome measure. Subjective pain scales and blood analysis will be a secondary outcome measure and will be used to assess the clinical efficacy of the intervention. Multimodal cerebral imaging will be used to detect cerebral activity changes in each treatment group. The clinical data and fMRI data will be analysed for all the groups. Multiple correlation regression analyses will be used to assess the association between changes in cerebral functional activity and the improvement of clinical outcomes after acupuncture treatment. Discussion This study is based on the results of the researchers’ previous study, and using combined clinical and cerebral function changes, it will help evaluate the effects of acupuncture on PDPN. The investigation of acupuncture’s central mechanism of action will further expand the understanding of acupuncture treatment of PDPN. Trial registration Chinese Clinical Trial Registry ChiCTR1900024109 . Registered on 26 June 2019.
format	article
author	Mengyuan Li Lin Yao Haipeng Huang Liying Zhang Haizhu Zheng Guan Wang Zhen Zhong Shiqi Ma Shuo Yu Hongfeng Wang
author_facet	Mengyuan Li Lin Yao Haipeng Huang Liying Zhang Haizhu Zheng Guan Wang Zhen Zhong Shiqi Ma Shuo Yu Hongfeng Wang
author_sort	Mengyuan Li
title	Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial
title_short	Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial
title_full	Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial
title_fullStr	Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial
title_full_unstemmed	Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial
title_sort	multimodal cerebral imaging study on the effects of “adjust zang dredge meridian” electroacupuncture on cerebral central sensitization in pdpn patients: a study protocol for a sham-controlled, randomized trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/9f2ab07becce4da88f2834d54b6e7a3a
work_keys_str_mv	AT mengyuanli multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT linyao multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT haipenghuang multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT liyingzhang multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT haizhuzheng multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT guanwang multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT zhenzhong multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT shiqima multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT shuoyu multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial AT hongfengwang multimodalcerebralimagingstudyontheeffectsofadjustzangdredgemeridianelectroacupunctureoncerebralcentralsensitizationinpdpnpatientsastudyprotocolforashamcontrolledrandomizedtrial
_version_	1718429183181324288

Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial

Ejemplares similares