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Shoe Modification and Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoe insert
walking shoes
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring lateral wedge inserts, shoe inserts

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to walk 30 feet without a walking aid Ability to stand unaided Ability to understand verbal instructions Ability to give informed consent Exclusion Criteria: History of knee trauma or surgery including arthroscopic surgery in the past 6 months Severe obesity (>30 kg/m2) Neurological disease Injury or amputation to the lower extremity joints History of other types of arthritis Symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6 months Poor health that would impair compliance or assessment such as shortness of breath with exertion

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

walking shoes

walking shoes + shoe insert

Arm Description

walking shoes

walking shoes + shoe insert

Outcomes

Primary Outcome Measures

WOMAC pain scale

Secondary Outcome Measures

Full Information

First Posted
March 11, 2005
Last Updated
October 20, 2015
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00105365
Brief Title
Shoe Modification and Knee Osteoarthritis
Official Title
Shoe Modification and Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial will assess the ability of shoe inserts to relieve pain and disability in people with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.
Detailed Description
Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Its prevalence increases with age, leading to about 65-85% of those age 65 years and older having OA. Involvement of the knee with OA is the main reason for significant functional impairment as it alters ambulation through pain and stiffness. Nonpharmacological management of knee OA includes the use of orthotic supports such as wedged insoles for varus or valgus knee deformities to relieve pain and improve function in the early stages of this joint disease. Although these interventions are desirable because they are simple and inexpensive, we do not have a clear understanding about their efficacy in relieving pain and disability in people with knee OA. We also do not know whether there is a relationship between changes in joint biomechanics that occur with wedged insoles and changes in function and progression of OA. Furthermore, information is lacking regarding which patients would benefit from wedged insoles. Answering these questions will be critically important in the development of guidelines for the prescription of wedged insoles in knee OA. Patients in this study will be evaluated at baseline and after wearing the lateral-wedged insoles immediately and after wearing the insoles for four weeks. The participants will wear lateral-wedged insoles for the painful knee(s) for as many hours and for as many days of the week as they can tolerate. Some subjects may use a neutral position insole for an asymptomatic knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
lateral wedge inserts, shoe inserts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
walking shoes
Arm Type
Placebo Comparator
Arm Description
walking shoes
Arm Title
walking shoes + shoe insert
Arm Type
Experimental
Arm Description
walking shoes + shoe insert
Intervention Type
Device
Intervention Name(s)
Shoe insert
Intervention Description
Subjects with knee OA underwent gait analysis and knee pain and function assessment at baseline while wearing walking shoes and after four weeks of wearing walking shoes with lateral-wedged insoles.
Intervention Type
Other
Intervention Name(s)
walking shoes
Intervention Description
walking shoes
Primary Outcome Measure Information:
Title
WOMAC pain scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to walk 30 feet without a walking aid Ability to stand unaided Ability to understand verbal instructions Ability to give informed consent Exclusion Criteria: History of knee trauma or surgery including arthroscopic surgery in the past 6 months Severe obesity (>30 kg/m2) Neurological disease Injury or amputation to the lower extremity joints History of other types of arthritis Symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6 months Poor health that would impair compliance or assessment such as shortness of breath with exertion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meika A Fang, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

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Shoe Modification and Knee Osteoarthritis

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