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Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial

BACKGROUND: According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has...

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Autores principales: Xu, Huanfang, Zhao, Hong, Kang, Liping, Huang, Shixi, Shi, Yin, Su, Wei, Han, Mingjuan, Wang, Wenyan, Wang, Chunyan, Zhang, Yuan, Guo, Lanping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063012/
https://www.ncbi.nlm.nih.gov/pubmed/30053899
http://dx.doi.org/10.1186/s13063-018-2794-1
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author Xu, Huanfang
Zhao, Hong
Kang, Liping
Huang, Shixi
Shi, Yin
Su, Wei
Han, Mingjuan
Wang, Wenyan
Wang, Chunyan
Zhang, Yuan
Guo, Lanping
author_facet Xu, Huanfang
Zhao, Hong
Kang, Liping
Huang, Shixi
Shi, Yin
Su, Wei
Han, Mingjuan
Wang, Wenyan
Wang, Chunyan
Zhang, Yuan
Guo, Lanping
author_sort Xu, Huanfang
collection PubMed
description BACKGROUND: According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA. METHODS: This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study. DISCUSSION: This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007. Registered on 29 February 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2794-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-60630122018-07-31 Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial Xu, Huanfang Zhao, Hong Kang, Liping Huang, Shixi Shi, Yin Su, Wei Han, Mingjuan Wang, Wenyan Wang, Chunyan Zhang, Yuan Guo, Lanping Trials Study Protocol BACKGROUND: According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA. METHODS: This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study. DISCUSSION: This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007. Registered on 29 February 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2794-1) contains supplementary material, which is available to authorized users. BioMed Central 2018-07-27 /pmc/articles/PMC6063012/ /pubmed/30053899 http://dx.doi.org/10.1186/s13063-018-2794-1 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Xu, Huanfang
Zhao, Hong
Kang, Liping
Huang, Shixi
Shi, Yin
Su, Wei
Han, Mingjuan
Wang, Wenyan
Wang, Chunyan
Zhang, Yuan
Guo, Lanping
Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
title Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
title_full Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
title_fullStr Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
title_full_unstemmed Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
title_short Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
title_sort moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063012/
https://www.ncbi.nlm.nih.gov/pubmed/30053899
http://dx.doi.org/10.1186/s13063-018-2794-1
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