title: Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial.
abstract: BACKGROUND
  The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care.
  
  
  METHODS
  This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach.
  
  
  CONCLUSIONS
  This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  KCT0000130.
authors.affiliation: Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Seunghoon
authors.initials: S
authors.lastname: Lee
authors.forename: Kun Hyung
authors.initials: KH
authors.lastname: Kim
authors.forename: Tae-Hun
authors.initials: TH
authors.lastname: Kim
authors.forename: Jung-Eun
authors.initials: JE
authors.lastname: Kim
authors.forename: Joo-Hee
authors.initials: JH
authors.lastname: Kim
authors.forename: Jung Won
authors.initials: JW
authors.lastname: Kang
authors.forename: Kyung-Won
authors.initials: KW
authors.lastname: Kang
authors.forename: So-Young
authors.initials: SY
authors.lastname: Jung
authors.forename: Ae-Ran
authors.initials: AR
authors.lastname: Kim
authors.forename: Hyo-Ju
authors.initials: HJ
authors.lastname: Park
authors.forename: Mi-Suk
authors.initials: MS
authors.lastname: Shin
authors.forename: Kwon-Eui
authors.initials: KE
authors.lastname: Hong
authors.forename: Ho-Sueb
authors.initials: HS
authors.lastname: Song
authors.forename: Jin-Bong
authors.initials: JB
authors.lastname: Choi
authors.forename: Hyung-Jun
authors.initials: HJ
authors.lastname: Kim
authors.forename: Sun-Mi
authors.initials: SM
authors.lastname: Choi
mesh_terms: D015669:Acupuncture Points; D004185:Disability Evaluation; D006801:Humans; D007717:Knee; D007719:Knee Joint; D009071:Moxibustion; D020370:Osteoarthritis, Knee / Q000150:complications / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010146:Pain; D010147:Pain Measurement; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method