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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial

Authors: Lin-lin Shen, Guo-fu Huang, Wen Tian, Ling-ling Yu, Xiao-cui Yuan, Zhao-qing Zhang, Jing Yin, Chao-yang Ma, Guo-wei Cai, Jian-wu Li, Ming-qiao Ding, Wei He, Xin-yan Gao, Bing Zhu, Xiang-hong Jing, Man Li

Published in: Trials | Issue 1/2015

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Abstract

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.
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Metadata
Title
Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial
Authors
Lin-lin Shen
Guo-fu Huang
Wen Tian
Ling-ling Yu
Xiao-cui Yuan
Zhao-qing Zhang
Jing Yin
Chao-yang Ma
Guo-wei Cai
Jian-wu Li
Ming-qiao Ding
Wei He
Xin-yan Gao
Bing Zhu
Xiang-hong Jing
Man Li
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0636-y

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