Clinical Trial: Shoe Modification and Knee Osteoarthritis

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

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 Treatment or Intervention
Knee Osteoarthritis
 Device: Shoe insert

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Determine whether lateral-wedged insoles will decrease the external varus knee moment and knee compressive force in subjects with medial compartment knee OA
Secondary Outcomes: Determine if changes in the forces correlate with changes in pain and function as measured by the WOMAC Pain and Physical Function Subscales
Expected Total Enrollment:  40

Study start: March 2004;  Expected completion: December 2005
Last follow-up: October 2005;  Data entry closure: November 2005

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   -   85 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


California
      Veterans Affairs Hospital, Greater Los Angeles Health Care System, Los Angeles,  California,  90073,  United States; Recruiting
Connie E Taylor, MD, BSc  310-478-3711  Ext. 43568 
Meika A Fang, MD, PhD,  Principal Investigator

More Information

Study ID Numbers:  040429
Record last reviewed:  March 2005
Last Updated:  March 11, 2005
Record first received:  March 11, 2005
ClinicalTrials.gov Identifier:  NCT00105365
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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