Walking Aids in the Management of Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00223795
First received: September 13, 2005
Last updated: February 3, 2009
Last verified: February 2009

September 13, 2005
February 3, 2009
July 2006
September 2008   (final data collection date for primary outcome measure)
Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
1.Assess whether use of the single point cane contralateral to the affected knee will alter gait biomechanics
Complete list of historical versions of study NCT00223795 on ClinicalTrials.gov Archive Site
Not Provided
  • 1.Determine whether using the cane will improve functional outcome and health-related quality of life
  • 2. Determine the reliability and validity of the Cane Use Cognitive Mediator Instrument and the Psychosocial Impact of Assistive Devices Scale
  • 3.Define the factors associated with possession and use of walking aid for knee OA
Not Provided
Not Provided
 
Walking Aids in the Management of Knee Osteoarthritis
Walking Aids in the Management of Obesity-Related Knee Osteoarthritis

The purpose of this study is to assess whether the single point cane will relieve pain and disability in overweight or obese people with knee OA through altered joint biomechanics and what factors influence acceptance of cane use.

Knee OA is an important cause of disability and falls in overweight or obese individuals and limits their attempts at exercise and subsequent weight loss. Walking aids such as canes have been recommended in the management of knee OA in order to decrease pain by reducing loading across the knee and to increase physical activity. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with limited mobility. No randomized controlled trials have studied the efficacy of walking aids on quality of life, pain, and function in overweight or obese individuals with symptomatic knee OA (5,6). The proposed research will evaluate the effects of walking aids in knee OA by testing the following hypothesis that the use of a single-point cane will decrease pain from knee OA by altering gait biomechanics and will improve walking function and quality of life in overweight or obese individuals with symptomatic knee OA.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Osteoarthritis
Device: Walking with a cane or without a cane (Guardian offset handled cane)
Guardian offset handled cane with sure grip
1
Cane device intervention
Intervention: Device: Walking with a cane or without a cane (Guardian offset handled cane)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 45-85 years old
  2. Able to walk 30 feet without postural sway and able to stand unaided
  3. Unilateral knee pain on movement with a WOMAC pain subscale of >35mm
  4. Documented osteoarthritis based on clinical and radiographic criteria
  5. Body Mass Index (BMI) > 25.0 - 29.9
  6. Ability to understand verbal and written instructions
  7. Ability to give informed consent determined by assessment of cognitive status

Exclusion Criteria:

  1. Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy. History of knee trauma or surgery, including arthroscopic surgery, in the past six months
  2. Severe obesity (weight > 300lbs)
  3. Upper body weakness
  4. Injury or amputation of the lower extremity joints
  5. History of other types of arthritis
  6. Spine, foot, or hip pain of sufficient magnitude to interfere with the evaluation of the index joint.
  7. Isolated patellofemoral disease manifested by primarily anterior knee pain in the absence of tibiofemoral radiographic finding.
  8. History of significant collateral or anterior cruciate ligament or meniscal injury to the index joint requiring at least one week of non weight bearing (minor ligamentous injury prior to 6 months is not an exclusion).
  9. Poor health that would impair compliance or assessment such as shortness of breath with exertion
  10. Neurological disease including vestibular dysfunction, or impaired vision
  11. Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
  12. Is unable to understand and complete the study questionnaires including visual analog scale (VAS) responses.
  13. Is unable to understand the study procedures.
  14. Investigator feels the patient is otherwise inappropriate for the study. The patient is participating in another clinical trial that would interfere with participation in this study
  15. Investigator feels the patient is otherwise inappropriate for the study.
  16. The patient is participating in another clinical trial that would interfere with participation in this study
Both
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00223795
F3873R
Not Provided
Fang, Meika - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Meika Fang, MD VA Greater Los Angeles Healthcare System, West LA
Department of Veterans Affairs
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP