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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

June 13, 2008

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

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 ^†

Same as current

Descriptive Information

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

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 ^†

Interventional

Study Design ^†

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

Condition ^†

Knee Osteoarthritis

Intervention ^†

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 ^†

Completed

Enrollment ^†

Completion Date

July 2007

Primary Completion Date

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

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Brazil

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698412

Responsible Party

Anamaria Jones, UNIFESP - Universidade Federal de Sao Paulo

Secondary IDs ^††

Study Sponsor ^†

Federal University of São Paulo

Collaborators ^††

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

Information Provided By

Federal University of São Paulo

Verification Date

May 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.