title: Impact of Cane Use on Bone Marrow Lesion Volume in People With Medial Knee Osteoarthritis (CUBA Trial).
abstract: BACKGROUND
  No effective cure exists for knee osteoarthritis (OA). Low-burden self-management strategies that can slow disease progression are needed. Bone marrow lesions (BMLs) are a source of knee pain and accelerate cartilage loss. Importantly, they may be responsive to biomechanical off-loading treatments.
  
  
  OBJECTIVE
  The study objective is to investigate whether, in people with medial tibiofemoral OA, daily cane use for 12 weeks reduces the volume of medial tibiofemoral BMLs and improves pain, physical function, and health-related quality of life.
  
  
  METHODS
  This study will be an assessor-masked, 2-arm, parallel-group, multisite randomized controlled trial.
  
  
  METHODS
  The community will serve as the setting for this study.
  
  
  METHODS
  The study participants will be people who are 50 years old or older and have medial tibiofemoral OA and at least 1 medial tibiofemoral BML.
  
  
  METHODS
  The participants will be allocated to either the cane group (using a cane daily whenever walking for 12 weeks) or the control group (not using any gait aid for 12 weeks).
  
  
  METHODS
  Outcomes will be measured at baseline and 13 weeks. The primary outcome will be total medial tibiofemoral BML volume measured from magnetic resonance imaging. Secondary outcomes will include BML volume of the medial tibia and/or femur, knee pain overall and on walking, physical function, participant-perceived global change, and health-related quality of life. Additional measures will include physical activity, cointerventions, adverse events, participation, participant demographics, cane training process measures and feasibility, barriers to and facilitators of cane use, and loss to follow-up.
  
  
  CONCLUSIONS
  People who are morbidly obese will not be included because of difficulties with magnetic resonance imaging.
  
  
  CONCLUSIONS
  The findings of this study will help to determine whether cane use can alter disease progression in people with medial tibiofemoral OA and/or influence clinical symptoms. This study may directly influence clinical guidelines for the management of knee OA.
authors.affiliation: Centre for Health, Exercise and Sports Medicine, The University of Melbourne, 161 Barry St, Alan Gilbert Level 7, Carlton, Victoria, Australia.
authors.forename: Ans
authors.initials: A
authors.lastname: Van Ginckel
authors.affiliation: Centre for Health, Exercise and Sports Medicine, The University of Melbourne.
authors.forename: Rana S
authors.initials: RS
authors.lastname: Hinman
authors.affiliation: Centre for Health, Exercise and Sports Medicine, The University of Melbourne.
authors.forename: Tim V
authors.initials: TV
authors.lastname: Wrigley
authors.affiliation: Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, and Department of Rheumatology, Royal North Shore Hospital, St Leonards, Sydney, New South Wales, Australia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Hunter
authors.affiliation: Centre for Health, Exercise and Sports Medicine, The University of Melbourne.
authors.forename: Charlotte J
authors.initials: CJ
authors.lastname: Marshall
authors.affiliation: Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, and Department of Rheumatology, Royal North Shore Hospital.
authors.forename: Luciano
authors.initials: L
authors.lastname: Melo
authors.affiliation: Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, and Department of Rheumatology, Royal North Shore Hospital.
authors.forename: Sarah R F
authors.initials: SRF
authors.lastname: Meneses
authors.affiliation: Department of Physical Therapy, The University of Sydney, Lidcombe, New South Wales, Australia.
authors.forename: Milena
authors.initials: M
authors.lastname: Simic
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Jessica
authors.initials: J
authors.lastname: Kasza
authors.affiliation: Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Jeff
authors.initials: J
authors.lastname: Duryea
authors.affiliation: Department of Physical Therapy, Eastern Health and La Trobe University, Melbourne, Victoria, Australia.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Wallis
authors.affiliation: Centre for Health, Exercise and Sports Medicine, The University of Melbourne.
authors.forename: Kim L
authors.initials: KL
authors.lastname: Bennell
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D001696:Biomechanical Phenomena; D001853:Bone Marrow / Q000000981:diagnostic imaging / Q000473:pathology*; D002183:Canes; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000000981:diagnostic imaging / Q000503:physiopathology*; D059408:Pain Management; D010147:Pain Measurement; D011788:Quality of Life; D016896:Treatment Outcome; D016474:Weight-Bearing