Walking Aids in the Management of Knee Osteoarthritis

Obesity Clinical Trial

Official title:

Walking Aids in the Management of Obesity-Related Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223795
• Other study ID #: F3873-R
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 29, 2017
• Start date: July 2006
• Est. completion date: October 2008

Study information

• Verified date: September 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Single point cane
Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Vertical Force on Affected Limb	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).	Baseline and end of first intervention period (2 months)