Effectiveness of Cane in Osteoarthritis (OA) Patients
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Cane
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Daily cane use, Pain, Function, Quality of life, Energy consumption during the gait
Eligibility 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
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Cane group
Control Group
Outcomes
Primary Outcome Measures
Pain - visual analogue scale
Secondary Outcome Measures
Function - Lequesne index
Function - WOMAC questionnaire
Quality of life - SF-36
Energy consumption (VO2)- gas analysis with and without cane during the 6MWT
Full Information
NCT ID
NCT00698412
First Posted
June 13, 2008
Last Updated
June 13, 2008
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00698412
Brief Title
Effectiveness of Cane in Osteoarthritis (OA) Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Daily cane use, Pain, Function, Quality of life, Energy consumption during the gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cane group
Arm Title
2
Arm Type
No Intervention
Arm Description
Control Group
Intervention Type
Device
Intervention Name(s)
Cane
Intervention Description
This group use the cane every day since the baseline
Primary Outcome Measure Information:
Title
Pain - visual analogue scale
Time Frame
T0, T30 and T60
Secondary Outcome Measure Information:
Title
Function - Lequesne index
Time Frame
T0, T30 and T60
Title
Function - WOMAC questionnaire
Time Frame
T0,T30 and T60
Title
Quality of life - SF-36
Time Frame
T0, T30 and T60
Title
Energy consumption (VO2)- gas analysis with and without cane during the 6MWT
Time Frame
T0, T30 and T60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anamaria Jones, PT
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamil Natour, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22128081
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Cane in Osteoarthritis (OA) Patients
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