Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105365
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2005-03-11
Brief Title:
Shoe Modification and Knee Osteoarthritis
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Shoe Modification and Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 knees 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None