NCT00698412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Jan 2005

Typical duration for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
Last Updated

June 17, 2008

Status Verified

May 1, 2008

Enrollment Period

2.5 years

First QC Date

June 13, 2008

Last Update Submit

June 13, 2008

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisDaily cane usePainFunctionQuality of lifeEnergy consumption during the gait

Outcome Measures

Primary Outcomes (1)

  • Pain - visual analogue scale

    T0, T30 and T60

Secondary Outcomes (4)

  • Function - Lequesne index

    T0, T30 and T60

  • Function - WOMAC questionnaire

    T0,T30 and T60

  • Quality of life - SF-36

    T0, T30 and T60

  • Energy consumption (VO2)- gas analysis with and without cane during the 6MWT

    T0, T30 and T60

Study Arms (2)

1

EXPERIMENTAL

Cane group

Device: Cane

2

NO INTERVENTION

Control Group

Interventions

CaneDEVICE

This group use the cane every day since the baseline

1

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 22128081DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Canes

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Anamaria Jones, PT

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Jamil Natour, MD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 17, 2008

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 17, 2008

Record last verified: 2008-05

Locations

BR(1)