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Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial
BACKGROUND: Previous studies have shown that electroacupuncture (EA) has a significant effect on acute pain, but it has not solved the clinical problem of the chronification of acute pain. Diffuse noxious inhibitory controls (DNIC) function as a reliable indicator to predict the risk of chronic pain...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411929/ https://www.ncbi.nlm.nih.gov/pubmed/25873092 http://dx.doi.org/10.1186/s13063-015-0636-y |
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author | Shen, Lin-lin Huang, Guo-fu Tian, Wen Yu, Ling-ling Yuan, Xiao-cui Zhang, Zhao-qing Yin, Jing Ma, Chao-yang Cai, Guo-wei Li, Jian-wu Ding, Ming-qiao He, Wei Gao, Xin-yan Zhu, Bing Jing, Xiang-hong Li, Man |
author_facet | Shen, Lin-lin Huang, Guo-fu Tian, Wen Yu, Ling-ling Yuan, Xiao-cui Zhang, Zhao-qing Yin, Jing Ma, Chao-yang Cai, Guo-wei Li, Jian-wu Ding, Ming-qiao He, Wei Gao, Xin-yan Zhu, Bing Jing, Xiang-hong Li, Man |
author_sort | Shen, Lin-lin |
collection | PubMed |
description | BACKGROUND: Previous studies have shown that electroacupuncture (EA) has a significant effect on acute pain, but it has not solved the clinical problem of the chronification of acute pain. Diffuse noxious inhibitory controls (DNIC) function as a reliable indicator to predict the risk of chronic pain events. DNIC function in knee osteoarthritis (KOA) patients has been demonstrated to gradually decrease during the development of chronic pain. The purpose of this study is to conduct a randomized, controlled clinical trial to determine if EA can repair impaired DNIC function and thus prevent chronification of the acute pain of KOA. METHODS/DESIGN: This is a multicenter, single blind, randomized, controlled, three-arm, large-scale clinical trial. A total of 450 KOA patients will be randomly assigned to three groups. The strong EA group will receive EA with high-intensity current (2 mA < current < 5 mA) at the ipsilateral ‘Neixiyan’ (EX-LE5), ‘Dubi’(ST35), ‘Liangqiu’(ST34) and ‘Xuehai’ (SP10). The weak EA group will receive EA with low-intensity current (0 mA < current < 0.5 mA) on the same acupoints. The sham EA group will receive EA with low-intensity current (0 mA < current < 0.5 mA) with fine needles inserted superficially into the sites 2 cm lateral to the above acupoints. The patients will be treated with EA once a day, 30 minutes per session, in 5 sessions per week, for 2 weeks. In order to determine the best stage of KOA for effective EA intervention, patients within the treatment groups also will be divided into four stages. The primary outcomes are Visual Analog Scale (VAS), DNIC function and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Clinical assessments will be evaluated at baseline (before treatment) and after 5 to 10 sessions of treatment. DISCUSSION: This trial will be helpful in identifying whether strong EA is more effective than weak EA in reversing chronification of acute pain through repairing the impaired DNIC function and in screening for the best stage of KOA for effective EA intervention. TRIAL REGISTRATION: Chinese Clinical Trial Registry Number: ChiCTR-ICR-14005411. The date of registration is 31 October 2014. |
format | Online Article Text |
id | pubmed-4411929 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-44119292015-04-29 Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial Shen, Lin-lin Huang, Guo-fu Tian, Wen Yu, Ling-ling Yuan, Xiao-cui Zhang, Zhao-qing Yin, Jing Ma, Chao-yang Cai, Guo-wei Li, Jian-wu Ding, Ming-qiao He, Wei Gao, Xin-yan Zhu, Bing Jing, Xiang-hong Li, Man Trials Study Protocol BACKGROUND: Previous studies have shown that electroacupuncture (EA) has a significant effect on acute pain, but it has not solved the clinical problem of the chronification of acute pain. Diffuse noxious inhibitory controls (DNIC) function as a reliable indicator to predict the risk of chronic pain events. DNIC function in knee osteoarthritis (KOA) patients has been demonstrated to gradually decrease during the development of chronic pain. The purpose of this study is to conduct a randomized, controlled clinical trial to determine if EA can repair impaired DNIC function and thus prevent chronification of the acute pain of KOA. METHODS/DESIGN: This is a multicenter, single blind, randomized, controlled, three-arm, large-scale clinical trial. A total of 450 KOA patients will be randomly assigned to three groups. The strong EA group will receive EA with high-intensity current (2 mA < current < 5 mA) at the ipsilateral ‘Neixiyan’ (EX-LE5), ‘Dubi’(ST35), ‘Liangqiu’(ST34) and ‘Xuehai’ (SP10). The weak EA group will receive EA with low-intensity current (0 mA < current < 0.5 mA) on the same acupoints. The sham EA group will receive EA with low-intensity current (0 mA < current < 0.5 mA) with fine needles inserted superficially into the sites 2 cm lateral to the above acupoints. The patients will be treated with EA once a day, 30 minutes per session, in 5 sessions per week, for 2 weeks. In order to determine the best stage of KOA for effective EA intervention, patients within the treatment groups also will be divided into four stages. The primary outcomes are Visual Analog Scale (VAS), DNIC function and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Clinical assessments will be evaluated at baseline (before treatment) and after 5 to 10 sessions of treatment. DISCUSSION: This trial will be helpful in identifying whether strong EA is more effective than weak EA in reversing chronification of acute pain through repairing the impaired DNIC function and in screening for the best stage of KOA for effective EA intervention. TRIAL REGISTRATION: Chinese Clinical Trial Registry Number: ChiCTR-ICR-14005411. The date of registration is 31 October 2014. BioMed Central 2015-04-01 /pmc/articles/PMC4411929/ /pubmed/25873092 http://dx.doi.org/10.1186/s13063-015-0636-y Text en © Shen et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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 Shen, Lin-lin Huang, Guo-fu Tian, Wen Yu, Ling-ling Yuan, Xiao-cui Zhang, Zhao-qing Yin, Jing Ma, Chao-yang Cai, Guo-wei Li, Jian-wu Ding, Ming-qiao He, Wei Gao, Xin-yan Zhu, Bing Jing, Xiang-hong Li, Man Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
title | Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
title_full | Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
title_fullStr | Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
title_full_unstemmed | Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
title_short | Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
title_sort | electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411929/ https://www.ncbi.nlm.nih.gov/pubmed/25873092 http://dx.doi.org/10.1186/s13063-015-0636-y |
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