title: Individually integrated traditional Chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Knee osteoarthritis (OA) is considered a major public health issue causing chronic disability worldwide with the increasing number of aging people. In China and increasingly worldwide, many sufferers with knee OA are using complementary and alternative medicine including herbal drug, herbal patch, acupuncture and Tuina etc., to alleviate their symptoms. However, evidence gathered from systematic reviews or randomized controlled trials (RCT) has only validated acupuncture for the management of osteoarthritic pain. Moreover, such Traditional Chinese Medicine (TCM) methods above are commonly used in an integrative way. This trial is aimed to compare the efficacy of an individually integrated TCM approach in the management of knee OA with other single treatments as parallel randomized controls.
  
  
  METHODS
  Five teaching hospitals will participate in this randomized controlled trial. 500 participants, 100 in each hospital, will be randomly assigned to receive oral administration of a Chinese herbal drug (counter osteophytes capsule), topical use of a Chinese herbal patch (Fufnag Zijin patch), acupuncture, Tuina and the individually integrated TCM approach. The individually integrated TCM approach consists of basic treatment of oral counter osteophytes capsule, variable use of Tuina, acupuncture and a herbal patch based on the severity of the patient's symptoms. The interventions are given for a period of 4 weeks. The primary outcome measure is the self-reported total score using the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures include patient and investigator global assessment of response to treatment, patient and investigator global assessment of OA condition, WOMAC pain, stiffness, and physical function subscales, short-form 36 (SF-36) and TCM assessment of OA condition measured by syndromes questionnaire. Mixed models and sensitivity analysis will be used for the statistical analysis.
  
  
  CONCLUSIONS
  The trial is designed to test the hypothesis that an individually integrated TCM approach is more effective than four treatment modalities used separately. The major limitation of this study is lack of placebo control and of double blinding.
  
  
  BACKGROUND
  Chinese Cochrane Center ChiCTR-TRC-00000176.
authors.affiliation: Research Institute of Orthopaedics, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Pudong New Area, 201203, Shanghai, China.
authors.forename: Yuelong
authors.initials: Y
authors.lastname: Cao
authors.forename: Hongsheng
authors.initials: H
authors.lastname: Zhan
authors.forename: Jian
authors.initials: J
authors.lastname: Pang
authors.forename: Feiyue
authors.initials: F
authors.lastname: Li
authors.forename: Shaojian
authors.initials: S
authors.lastname: Xu
authors.forename: Jinghua
authors.initials: J
authors.lastname: Gao
authors.forename: Zhanwang
authors.initials: Z
authors.lastname: Xu
authors.forename: Gang
authors.initials: G
authors.lastname: Li
authors.forename: Ting
authors.initials: T
authors.lastname: Liu
authors.forename: Chaoqing
authors.initials: C
authors.lastname: Guo
authors.forename: Yinyu
authors.initials: Y
authors.lastname: Shi
mesh_terms: D015670:Acupuncture Therapy; D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002681:China; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D006784:Hospitals, Teaching; D006801:Humans; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000628:therapy*; D011446:Prospective Studies; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal