Effectiveness of Cane in Osteoarthritis (OA) Patients

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698412
• Other study ID #: UNIFESP-102/2004
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2008
• Last updated: June 13, 2008
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Cane
This group use the cane every day since the baseline

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain - visual analogue scale		T0, T30 and T60	No
Secondary	Function - Lequesne index		T0, T30 and T60	No
Secondary	Function - WOMAC questionnaire		T0,T30 and T60	No
Secondary	Quality of life - SF-36		T0, T30 and T60	No
Secondary	Energy consumption (VO2)- gas analysis with and without cane during the 6MWT		T0, T30 and T60	No