title: Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry Number: ChiCTR-ICR-14005411. The date of registration is 31 October 2014.
authors: Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, No.13 Hang Kong Road, Wuhan, 430030, P. R. China. 434454364@qq.com.|Combined Traditional Chinese and Western Medicine Hospital affiliated to Hubei University of Traditional Chinese Medicine, No.215 Zhong Shan Road, Wuhan, 430022, P. R. China. 434454364@qq.com.
authors: Lin-lin
authors: LL
authors: Shen
authors: Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, No.13 Hang Kong Road, Wuhan, 430030, P. R. China. hgfmkp@aliyun.com.|Combined Traditional Chinese and Western Medicine Hospital affiliated to Hubei University of Traditional Chinese Medicine, No.215 Zhong Shan Road, Wuhan, 430022, P. R. China. hgfmkp@aliyun.com.
authors: Guo-fu
authors: GF
authors: Huang
authors: Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, No.13 Hang Kong Road, Wuhan, 430030, P. R. China. 352141787@qq.com.|Combined Traditional Chinese and Western Medicine Hospital affiliated to Hubei University of Traditional Chinese Medicine, No.215 Zhong Shan Road, Wuhan, 430022, P. R. China. 352141787@qq.com.
authors: Wen
authors: W
authors: Tian
authors: Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, No.13 Hang Kong Road, Wuhan, 430030, P. R. China. 527679774@qq.com.|Combined Traditional Chinese and Western Medicine Hospital affiliated to Hubei University of Traditional Chinese Medicine, No.215 Zhong Shan Road, Wuhan, 430022, P. R. China. 527679774@qq.com.
authors: Ling-ling
authors: LL
authors: Yu
authors: Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, No.13 Hang Kong Road, Wuhan, 430030, P. R. China. 876702537@qq.com.
authors: Xiao-cui
authors: XC
authors: Yuan
authors: The Third Hospital of Wuhan, No.241 Peng Liuyang Road, Wuhan, 430060, P. R. China. 2568584089@qq.com.
authors: Zhao-qing
authors: ZQ
authors: Zhang
authors: The Third Hospital of Wuhan, No.241 Peng Liuyang Road, Wuhan, 430060, P. R. China. 37590328@qq.com.
authors: Jing
authors: J
authors: Yin
authors: Central Hospital of Wuhan, No.26 Sheng Li Road, Wuhan, 430014, P. R. China. 376592187@qq.com.
authors: Chao-yang
authors: CY
authors: Ma
authors: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1277 Jiefang Ave, Wuhan, 430022, P. R. China. cgw645@163.com.
authors: Guo-wei
authors: GW
authors: Cai
authors: Wuhan Hospital of Traditional Chinese Medicine, No.49 Li Huangpi Road, Wuhan, 430014, P. R. China. Ljw.1955@aliyun.com.
authors: Jian-wu
authors: JW
authors: Li
authors: The Fifth Hospital of Wuhan, No.122 Xian Zheng Road, Wuhan, 430050, P. R. China. dingmingqiao@126.com.
authors: Ming-qiao
authors: MQ
authors: Ding
authors: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie of Dongzhimennei, Beijing, 100700, P. R. China. 2233058@qq.com.
authors: Wei
authors: W
authors: He
authors: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie of Dongzhimennei, Beijing, 100700, P. R. China. gaoxy@mail.cintcm.ac.cn.
authors: Xin-yan
authors: XY
authors: Gao
authors: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie of Dongzhimennei, Beijing, 100700, P. R. China. zhubing@mail.cintcm.ac.cn.
authors: Bing
authors: B
authors: Zhu
authors: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie of Dongzhimennei, Beijing, 100700, P. R. China. xianghongjing@hotmail.com.
authors: Xiang-hong
authors: XH
authors: Jing
authors: Department of Neurobiology, School of Basic Medicine, Tongji Medical College of Huazhong University of Science and Technology, No.13 Hang Kong Road, Wuhan, 430030, P. R. China. liman7322@hotmail.com.
authors: Man
authors: M
authors: Li
mesh_terms: D059787:Acute Pain / Q000628:therapy*; D002985:Clinical Protocols; D015671:Electroacupuncture; D006801:Humans; D020370:Osteoarthritis, Knee / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D016037:Single-Blind Method