Effectiveness of Cane in Osteoarthritis (OA) Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

June 13, 2008

Last Updated Date

June 13, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain - visual analogue scale [ Time Frame: T0, T30 and T60 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Function - Lequesne index [ Time Frame: T0, T30 and T60 ] [ Designated as safety issue: No ]
Function - WOMAC questionnaire [ Time Frame: T0,T30 and T60 ] [ Designated as safety issue: No ]
Quality of life - SF-36 [ Time Frame: T0, T30 and T60 ] [ Designated as safety issue: No ]
Energy consumption (VO2)- gas analysis with and without cane during the 6MWT [ Time Frame: T0, T30 and T60 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Cane in Osteoarthritis (OA) Patients

Official Title ^ICMJE

The Impact of Daily Cane Use on Pain, Function, Quality of Life and Energy Consumption During the Gait in Patients With Knee Osteoarthritis

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment

Condition ^ICMJE

Knee Osteoarthritis

Intervention ^ICMJE

Device: Cane

Study Arms / Comparison Groups

Experimental: Cane group
No Intervention: Control Group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00698412

Responsible Party

Anamaria Jones, UNIFESP - Universidade Federal de Sao Paulo

Study ID Numbers ^ICMJE

UNIFESP-102/2004

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

Principal Investigator:	Anamaria Jones, PT	Federal University of São Paulo
Study Chair:	Jamil Natour, MD	Federal University of São Paulo

Information Provided By

Federal University of São Paulo

Verification Date

May 2008

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