title: Clinical effectiveness and micro-perfusion alteration of Jingui external lotion in patients with knee osteoarthritis: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Knee osteoarthritis is a major cause of disability in the aging population. Based on pathological, magnetic resonance imaging (MRI) and arthroscopy studies, progressive osteoarthritis involves all tissues of the joint and includes bone marrow lesions, synovial proliferation, fat pad inflammation, and high subchondral bone turnover. Recent research suggests that abnormal perfusion in bone marrow lesions, fat pads, and subchondral bone is associated with pain in knee osteoarthritis, and that dynamic contrast-enhanced MRI is a promising method for studying micro-perfusion alteration in knee osteoarthritis. Traditional Chinese Medicine approaches have been employed for thousands of years to relieve knee osteoarthritis pain. Among herbal medicines, the Jingui external lotion is the preferred and most commonly used method in China to reduce pain in patients with knee osteoarthritis; however, there is a lack of validated evidence for its effectiveness. The purpose of this study is to explore the effectiveness of Jingui external lotion for the management of painful knee osteoarthritis in a short-term study. In addition, we will assess micro-perfusion alteration in the patellar fat pad as well as the femur and tibia subchondral bone via dynamic contrast-enhanced MRI.
  
  
  METHODS
  This trial is a randomized, controlled study. A total of 168 patients will be randomized into the following two groups: 1) the Jingui external lotion group (treatment group); and 2) the placebo lotion group (control group). In both groups, lotion fumigation and external washing of the patients' knees will be administered twice a day for 14 consecutive days. Follow-up will be at regular intervals during a 4-week period with a visual analog scale to assess pain, and additional characterization with the Western Ontario and McMaster Universities Index score; rescue medication will be recorded as the extent and time pattern. In addition, micro-perfusion alteration in the patellar fat pad, femur and tibia subchondral bone will be assessed via dynamic contrast-enhanced MRI.
  
  
  CONCLUSIONS
  This study will provide clinical evidence of the efficacy of Jingui external lotion in treating knee osteoarthritis, and it will be the first randomized controlled trial to investigate micro-perfusion alteration of knee osteoarthritis with Traditional Chinese Medicine external lotion via dynamic contrast-enhanced MRI.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: ChiCTR-TRC-14004727 ; 31 May 2014.
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. 341127403@QQ.COM.
authors: Da
authors: D
authors: Guo
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. CAOXUEWEI@126.COM.
authors: Xue-Wei
authors: XW
authors: Cao
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. LIUJINWEN2003@126.COM.
authors: Jin-Wen
authors: JW
authors: Liu
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. niuwei@139.com.
authors: Wei
authors: W
authors: Niu
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. 379923475@qq.com.
authors: Zhen-Wei
authors: ZW
authors: Ma
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. lindingkun@126.com.
authors: Ding-Kun
authors: DK
authors: Lin
authors: Department of Orthopedic Surgery, Hospital of Traditional Chinese Medicine of Zhongshan, No. 3 Xunkang Road, Zhongshan, Guangdong, 528400, China. 258001053@qq.com.
authors: Jia-Yi
authors: JY
authors: Chen
authors: Department of Orthopedic Surgery, Hospital of Traditional Chinese Medicine of Meizhou, No. 35 Meishong Road, Meizhou, Guangdong, 514000, China. Lianweidonglove@21cn.com.
authors: Wei-Dong
authors: WD
authors: Lian
authors: Department of Statistical Secretary, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. 35635369@QQ.COM.
authors: Wen-Wei
authors: WW
authors: Ouyang
authors: Department of Orthopedic Surgery, The Second School of Clinic Medicine, Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. liujun.gdtcm@hotmail.com.
authors: Jun
authors: J
authors: Liu
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D008516:Medicine, Chinese Traditional; D020370:Osteoarthritis, Knee / Q000628:therapy*; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D012107:Research Design; D063465:Skin Cream / Q000627:therapeutic use*
chemical_list: D028321:Plant Preparations