Effectiveness of Cane in Osteoarthritis (OA) Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00698412
First received: June 13, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Experimental: 1
Cane group
Device: Cane
This group use the cane every day since the baseline
No Intervention: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
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 by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anamaria Jones, UNIFESP - Universidade Federal de Sao Paulo
ClinicalTrials.gov Identifier: NCT00698412     History of Changes
Other Study ID Numbers: UNIFESP-102/2004
Study First Received: June 13, 2008
Last Updated: June 13, 2008
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
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014