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Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial

BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases...

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Autores principales: Kang, Ha-Ra, Jung, Chan-Yung, Lee, Seung-Deok, Kim, Kyung-Ho, Kim, Kap-Sung, Kim, Eun-Jung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5836464/
https://www.ncbi.nlm.nih.gov/pubmed/29506572
http://dx.doi.org/10.1186/s13063-018-2514-x
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author Kang, Ha-Ra
Jung, Chan-Yung
Lee, Seung-Deok
Kim, Kyung-Ho
Kim, Kap-Sung
Kim, Eun-Jung
author_facet Kang, Ha-Ra
Jung, Chan-Yung
Lee, Seung-Deok
Kim, Kyung-Ho
Kim, Kap-Sung
Kim, Eun-Jung
author_sort Kang, Ha-Ra
collection PubMed
description BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS: This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION: This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2514-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-58364642018-03-07 Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial Kang, Ha-Ra Jung, Chan-Yung Lee, Seung-Deok Kim, Kyung-Ho Kim, Kap-Sung Kim, Eun-Jung Trials Study Protocol BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS: This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION: This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2514-x) contains supplementary material, which is available to authorized users. BioMed Central 2018-03-05 /pmc/articles/PMC5836464/ /pubmed/29506572 http://dx.doi.org/10.1186/s13063-018-2514-x 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
Kang, Ha-Ra
Jung, Chan-Yung
Lee, Seung-Deok
Kim, Kyung-Ho
Kim, Kap-Sung
Kim, Eun-Jung
Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title_full Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title_fullStr Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title_full_unstemmed Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title_short Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title_sort efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5836464/
https://www.ncbi.nlm.nih.gov/pubmed/29506572
http://dx.doi.org/10.1186/s13063-018-2514-x
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