title: Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial.
abstract: BACKGROUND
  Knee Osteoarthritis (KOA) is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching) on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009.
  
  
  METHODS
  Forty eligible patients, age > 55 yr, BMI < or = 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria) are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi) or attention control (wellness education and stretching). The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC) pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks.
  
  
  CONCLUSIONS
  In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence/follow-up while conducting the clinical trial for the evaluation of the effectiveness of Tai Chi on KOA.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00362453.
authors.affiliation: Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. cwang2@tuftsmedicalcenter.org
authors.forename: Chenchen
authors.initials: C
authors.lastname: Wang
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Schmid
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Hibberd
authors.forename: Robert
authors.initials: R
authors.lastname: Kalish
authors.forename: Ronenn
authors.initials: R
authors.lastname: Roubenoff
authors.forename: Ramel
authors.initials: R
authors.lastname: Rones
authors.forename: Aghogho
authors.initials: A
authors.lastname: Okparavero
authors.forename: Timothy
authors.initials: T
authors.lastname: McAlindon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003863:Depression / Q000523:psychology; D005081:Exercise Therapy / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging / Q000503:physiopathology; D008137:Longitudinal Studies; D008875:Middle Aged; D009043:Motor Activity; D020370:Osteoarthritis, Knee / Q000503:physiopathology* / Q000523:psychology / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010349:Patient Compliance / Q000523:psychology; D018579:Patient Selection; D011584:Psychology; D011788:Quality of Life / Q000523:psychology; D011859:Radiography; D016059:Range of Motion, Articular / Q000502:physiology; D016037:Single-Blind Method; D026302:Tai Ji