Walking Aids in the Management of Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00223795
First received: September 13, 2005
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Obesity
Osteoarthritis
Device: Single point cane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Walking Aids in the Management of Obesity-Related Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Peak Vertical Force on Affected Limb [ Time Frame: Baseline and end of first intervention period (2 months) ] [ Designated as safety issue: No ]
    An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).


Enrollment: 53
Study Start Date: July 2006
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single point cane
People with knee osteoarthritis underwent gait analysis with a cane
Device: Single point cane
Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
Other Name: Guardian offset handled cane with sure grip
Placebo Comparator: No cane
Patients with knee osteoarthritis undergo gait analysis without a cane

Detailed Description:

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 ipsilateral and contralateral to the affected limb 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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Severe obesity (weight > 300lbs)
  • Upper body weakness
  • Injury or amputation of the lower extremity joints
  • History of other types of arthritis
  • Spine, foot, or hip pain of sufficient magnitude to interfere with the evaluation of the index joint.
  • Isolated patellofemoral disease manifested by primarily anterior knee pain in the absence of tibiofemoral radiographic finding.
  • 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).
  • Poor health that would impair compliance or assessment such as shortness of breath with exertion
  • Neurological disease including vestibular dysfunction, or impaired vision
  • 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.
  • Is unable to understand and complete the study questionnaires including visual analog scale (VAS) responses.
  • Is unable to understand the study procedures.
  • 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
  • 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
  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: NCT00223795

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Meika Fang, MD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223795     History of Changes
Other Study ID Numbers: F3873-R
Study First Received: September 13, 2005
Results First Received: September 24, 2013
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cane
Gait
Obesity
Osteoarthritis
Walking Aids

Additional relevant MeSH terms:
Obesity
Osteoarthritis, Knee
Osteoarthritis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014