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CompletedNCT00698412Updated Jun 17, 2008

Effectiveness of Cane in Osteoarthritis (OA) Patients

A Phase 4 interventional study of Cane in Knee Osteoarthritis, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Knee osteoarthritis
  • Daily cane use
  • Pain
  • Function
  • Quality of life
  • Energy consumption during the gait
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 64 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    1

    Cane group

    Device: Cane

  • No intervention
    2

    Control Group

Interventions

  • DeviceCane

    This group use the cane every day since the baseline

06

What researchers measure

Primary outcomes

  1. Pain - visual analogue scale

    Time frame: T0, T30 and T60

Secondary outcomes

  1. Function - Lequesne index

    Time frame: T0, T30 and T60

  2. Function - WOMAC questionnaire

    Time frame: T0,T30 and T60

  3. Quality of life - SF-36

    Time frame: T0, T30 and T60

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

    Time frame: T0, T30 and T60

07

Study locations

1 site
  • Federal University of Sao Paulo
    Sao Paulo, SP, Brazil
08

References and documents

Publications

  • 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. PubMed 22128081 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00698412
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted
Jun 17, 2008
Start date
Jan 2005
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Jun 17, 2008

Study contacts

Anamaria Jones, PT
principal investigator · Federal University of São Paulo
Jamil Natour, MD
study chair · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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