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Effectiveness of Cane in Osteoarthritis (OA) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698412
First Posted: June 17, 2008
Last Update Posted: June 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
June 13, 2008
June 17, 2008
June 17, 2008
January 2005
July 2007   (Final data collection date for primary outcome measure)
Pain - visual analogue scale [ Time Frame: T0, T30 and T60 ]
Same as current
No Changes Posted
  • Function - Lequesne index [ Time Frame: T0, T30 and T60 ]
  • Function - WOMAC questionnaire [ Time Frame: T0,T30 and T60 ]
  • Quality of life - SF-36 [ Time Frame: T0, T30 and T60 ]
  • Energy consumption (VO2)- gas analysis with and without cane during the 6MWT [ Time Frame: T0, T30 and T60 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Cane in Osteoarthritis (OA) Patients
The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis
Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.
Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
Device: Cane
This group use the cane every day since the baseline
  • Experimental: 1
    Cane group
    Intervention: Device: Cane
  • No Intervention: 2
    Control Group
Jones A, Silva PG, Silva AC, Colucci M, Tuffanin A, Jardim JR, Natour J. Impact of cane use on pain, function, general health and energy expenditure during gait in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2012 Feb;71(2):172-9. doi: 10.1136/ard.2010.140178. Epub 2011 Nov 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary Knee osteoarthritis (ACR criteria)
  • VAS for knee pain between 3 and 7
  • No changes the NSAID intake or physical activity in the previous 3 months

Exclusion Criteria:

  • Symptomatic heart or pulmonary disease
  • Severe systemic disease
  • Other symptomatic disease in the lower limb or in the upper limb that will carry the cane
  • Joint injection in the previous 3 months
  • PT in the previous 3 months
  • Previously cane use
  • Start regular physical activity in the last month
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00698412
UNIFESP-102/2004
Yes
Not Provided
Not Provided
Anamaria Jones, UNIFESP - Universidade Federal de Sao Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Anamaria Jones, PT Federal University of São Paulo
Study Chair: Jamil Natour, MD Federal University of São Paulo
Federal University of São Paulo
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP