Effectiveness of Cane in Osteoarthritis (OA) Patients

June 13, 2008 updated by: Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain - visual analogue scale
Time Frame: T0, T30 and T60
T0, T30 and T60

Secondary Outcome Measures

Outcome Measure
Time Frame
Function - Lequesne index
Time Frame: T0, T30 and T60
T0, T30 and T60
Function - WOMAC questionnaire
Time Frame: T0,T30 and T60
T0,T30 and T60
Quality of life - SF-36
Time Frame: T0, T30 and T60
T0, T30 and T60
Energy consumption (VO2)- gas analysis with and without cane during the 6MWT
Time Frame: T0, T30 and T60
T0, T30 and T60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIFESP-102/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe