A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
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|ClinicalTrials.gov Identifier: NCT00076453|
Recruitment Status : Completed
First Posted : January 26, 2004
Last Update Posted : September 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Lateral wedge orthotic shoe inserts Device: Standard orthotic shoe inserts||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Effects of Altered Biomechanics in Knee Osteoarthritis|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
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
- Pain reduction [ Time Frame: Years 2 and 3 ]
- Reduction in loading of the medial knee [ Time Frame: Years 2 and 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|