Effectiveness of Cane in Osteoarthritis (OA) Patients - Full Text View

Sponsor:	Federal University of São Paulo
Collaborator:	Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00698412

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
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:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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

Primary Outcome Measures:

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

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 ]

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
1: Experimental Cane group	Device: Cane This group use the cane every day since the baseline
2: No Intervention Control Group

Detailed Description:

Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698412

Locations

Brazil, SP
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

No publications provided

Responsible Party:	UNIFESP - Universidade Federal de Sao Paulo ( Anamaria Jones )
Study ID Numbers:	UNIFESP-102/2004
Study First Received:	June 13, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00698412 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

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, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2009