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Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial
BACKGROUND: Parkinson’s disease (PD) is the second most common neurodegenerative disorder and seriously affects quality of life globally. Moxibustion is widely used to treat neurodegenerative diseases in the clinic and has achieved a beneficial clinical effect. However, strict control and high-quali...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10258984/ https://www.ncbi.nlm.nih.gov/pubmed/37303044 http://dx.doi.org/10.1186/s12906-023-03995-w |
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author | Wu, Chunxiao Zhao, Lijun Guo, Yuelin Hao, Xiaoqian Fan, Yaohua Wu, Peipei Han, Jiajun Li, Qinglian Wang, Xiaoling Wang, Qizhang Luo, Xiaodong Zhu, Meiling |
author_facet | Wu, Chunxiao Zhao, Lijun Guo, Yuelin Hao, Xiaoqian Fan, Yaohua Wu, Peipei Han, Jiajun Li, Qinglian Wang, Xiaoling Wang, Qizhang Luo, Xiaodong Zhu, Meiling |
author_sort | Wu, Chunxiao |
collection | PubMed |
description | BACKGROUND: Parkinson’s disease (PD) is the second most common neurodegenerative disorder and seriously affects quality of life globally. Moxibustion is widely used to treat neurodegenerative diseases in the clinic and has achieved a beneficial clinical effect. However, strict control and high-quality randomized controlled trials are still lacking. Therefore, this trial aims to evaluate the clinical efficacy and safety of moxibustion in patients with PD and preliminarily explore the underlying mechanism. METHODS: This is a randomized, single-blind and placebo-controlled trial design in which 70 eligible participants will be randomly divided into a moxibustion group and a sham moxibustion group. Baihui (DU20) and Sishenchong (EX-HN1) are selected for both groups. The treatment will be performed for 30 min per session, two sessions a week for 8 weeks. The mean change in MDS-UPDRS scores (including MDS-UPDRS II, III subscale scores and total scores) from baseline to the observation points will be the primary outcome. The secondary outcomes will include scores on the Parkinson’s Disease Questionnaire-39 (PDQ-39), Fatigue Severity Scale (FSS), Parkinson Disease Sleep Scale (PDSS), Montreal Cognitive Assessment (MoCA), and Self-Rating Depression Scale (SDS) as well as the Wexner constipation score. All the above outcomes will be assessed at 4 and 8 weeks. Laboratory blood biochemical analysis and functional magnetic resonance imaging (fMRI) will be conducted at baseline and at the end of treatment to explore the potential mechanisms of moxibustion in regulating PD. DISCUSSION: In conclusion, the results of this trial will reveal whether moxibustion is effective for treating motor and nonmotor symptoms in PD. This trial will also preliminarily explore the underlying mechanism of the regulatory effect of moxibustion in PD, which will contribute to providing a theoretical basis for the treatment of PD. TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000029745. Registered on 9 August 2021. |
format | Online Article Text |
id | pubmed-10258984 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-102589842023-06-13 Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial Wu, Chunxiao Zhao, Lijun Guo, Yuelin Hao, Xiaoqian Fan, Yaohua Wu, Peipei Han, Jiajun Li, Qinglian Wang, Xiaoling Wang, Qizhang Luo, Xiaodong Zhu, Meiling BMC Complement Med Ther Study Protocol BACKGROUND: Parkinson’s disease (PD) is the second most common neurodegenerative disorder and seriously affects quality of life globally. Moxibustion is widely used to treat neurodegenerative diseases in the clinic and has achieved a beneficial clinical effect. However, strict control and high-quality randomized controlled trials are still lacking. Therefore, this trial aims to evaluate the clinical efficacy and safety of moxibustion in patients with PD and preliminarily explore the underlying mechanism. METHODS: This is a randomized, single-blind and placebo-controlled trial design in which 70 eligible participants will be randomly divided into a moxibustion group and a sham moxibustion group. Baihui (DU20) and Sishenchong (EX-HN1) are selected for both groups. The treatment will be performed for 30 min per session, two sessions a week for 8 weeks. The mean change in MDS-UPDRS scores (including MDS-UPDRS II, III subscale scores and total scores) from baseline to the observation points will be the primary outcome. The secondary outcomes will include scores on the Parkinson’s Disease Questionnaire-39 (PDQ-39), Fatigue Severity Scale (FSS), Parkinson Disease Sleep Scale (PDSS), Montreal Cognitive Assessment (MoCA), and Self-Rating Depression Scale (SDS) as well as the Wexner constipation score. All the above outcomes will be assessed at 4 and 8 weeks. Laboratory blood biochemical analysis and functional magnetic resonance imaging (fMRI) will be conducted at baseline and at the end of treatment to explore the potential mechanisms of moxibustion in regulating PD. DISCUSSION: In conclusion, the results of this trial will reveal whether moxibustion is effective for treating motor and nonmotor symptoms in PD. This trial will also preliminarily explore the underlying mechanism of the regulatory effect of moxibustion in PD, which will contribute to providing a theoretical basis for the treatment of PD. TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000029745. Registered on 9 August 2021. BioMed Central 2023-06-12 /pmc/articles/PMC10258984/ /pubmed/37303044 http://dx.doi.org/10.1186/s12906-023-03995-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Wu, Chunxiao Zhao, Lijun Guo, Yuelin Hao, Xiaoqian Fan, Yaohua Wu, Peipei Han, Jiajun Li, Qinglian Wang, Xiaoling Wang, Qizhang Luo, Xiaodong Zhu, Meiling Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial |
title | Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial |
title_full | Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial |
title_fullStr | Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial |
title_full_unstemmed | Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial |
title_short | Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial |
title_sort | moxibustion treatment for parkinson’s disease: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10258984/ https://www.ncbi.nlm.nih.gov/pubmed/37303044 http://dx.doi.org/10.1186/s12906-023-03995-w |
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