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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
  Purpose
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.

Condition Intervention Phase
Knee Osteoarthritis Device: Cane Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain - visual analogue scale [ Time Frame: T0, T30 and T60 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cane group
Device: Cane
This group use the cane every day since the baseline
No Intervention: 2
Control Group

Detailed Description:
Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698412


Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Anamaria Jones, PT Federal University of São Paulo
Study Chair: Jamil Natour, MD Federal University of São Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anamaria Jones, UNIFESP - Universidade Federal de Sao Paulo
ClinicalTrials.gov Identifier: NCT00698412     History of Changes
Other Study ID Numbers: UNIFESP-102/2004
First Submitted: June 13, 2008
First Posted: June 17, 2008
Last Update Posted: June 17, 2008
Last Verified: May 2008

Keywords provided by Federal University of São Paulo:
Knee osteoarthritis
Daily cane use
Pain
Function
Quality of life
Energy consumption during the gait

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases