A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
|Osteoarthritis||Device: Lateral wedge orthotic shoe inserts Device: Standard orthotic shoe inserts|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Effects of Altered Biomechanics in Knee Osteoarthritis|
- Pain reduction [ Time Frame: Years 2 and 3 ]
- Reduction in loading of the medial knee [ Time Frame: Years 2 and 3 ]
|Study Start Date:||June 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Participants will wear lateral wedge orthotic inserts.
Device: Lateral wedge orthotic shoe inserts
Customized lateral wedge orthotic shoe inserts
Active Comparator: 2
Participants will wear standard orthotic inserts.
Device: Standard orthotic shoe inserts
Neutral orthotic inserts
Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints. Knee OA causes substantial pain, suffering, and disability, as well as enormous economic burden on the patient; unfortunately, treatment provides relief but not a cure. The majority of patients with symptomatic knee OA do not attain satisfactory long-term relief, even with recent advances in pain relievers. Analgesic treatment may relieve the pain but does not improve biomechanics and may even aggravate OA.
Although OA is complex and not completely understood, disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading. Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration; one such device is a lateral wedge orthotic shoe insert. When worn during weight-bearing activity, these inserts have been shown to reduce loading of the medial compartment and may provide pain relief. This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA. The study will also assess improvements in loading biomechanics of the knee.
This is a 3-year study. Patients will be randomly assigned to one of two groups; the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts. There will be 10 study visits during the course of the study. Patients will undergo X-rays and bone mineral density testing (DEXA) and 3 blood collections during the course of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076453
|United States, Illinois|
|Rush University Medical Center, Section of Rheumatology|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Joel A. Block, MD||Rush University Medical Center, Section of Rheumatology|