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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00076453 |
Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis.
Condition | Intervention |
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Osteoarthritis |
Device: Lateral wedge orthotic shoe inserts Device: Standard orthotic shoe inserts |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Effects of Altered Biomechanics in Knee Osteoarthritis |
Enrollment: | 100 |
Study Start Date: | June 2003 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will wear lateral wedge orthotic inserts.
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Device: Lateral wedge orthotic shoe inserts
Customized lateral wedge orthotic shoe inserts
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2: Active Comparator
Participants will wear standard orthotic inserts.
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Device: Standard orthotic shoe inserts
Neutral orthotic inserts
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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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
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 |
Responsible Party: | Rush University Medical Center ( Joel A. Block, MD ) |
Study ID Numbers: | NIAMS-116, 2P50 AR39239-16 |
Study First Received: | January 22, 2004 |
Last Updated: | December 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00076453 History of Changes |
Health Authority: | United States: Federal Government |
Knee Pain Degenerative Arthritis Cartilage Disease Non-drug Therapy |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Cartilage Diseases Pain Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |