Shoe Modification and Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105365
First received: March 11, 2005
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Device: Shoe insert

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Shoe Modification and Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • WOMAC pain scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: walking shoes
walking shoes
Experimental: walking shoes + shoe insert
walking shoes + shoe insert
Device: Shoe insert
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00105365

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

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105365     History of Changes
Other Study ID Numbers: A3120-P
Study First Received: March 11, 2005
Last Updated: September 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
lateral wedge inserts
shoe inserts

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014