Shoe Modification and Knee Osteoarthritis
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.
|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|
- WOMAC pain scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Placebo Comparator: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105365
|United States, California|
|VA Greater Los Angeles Healthcare System, West LA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Meika Fang, MD||VA Greater Los Angeles Healthcare System, West LA|