A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
NCT ID: NCT00076453
Last Updated: 2011-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2003-06-30
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Participants will wear lateral wedge orthotic inserts.
Lateral wedge orthotic shoe inserts
Customized lateral wedge orthotic shoe inserts
2
Participants will wear standard orthotic inserts.
Standard orthotic shoe inserts
Neutral orthotic inserts
Interventions
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Lateral wedge orthotic shoe inserts
Customized lateral wedge orthotic shoe inserts
Standard orthotic shoe inserts
Neutral orthotic inserts
Eligibility Criteria
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Inclusion Criteria
* Symptomatic and radiographic OA of the knee
* Knee pain upon walking
* Predominant medial compartment OA
Exclusion Criteria
* Predominant lateral compartment OA of either knee
* Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
* Clinically evident OA of the ankle or hip
* Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
* Substantial obesity, defined as having body mass index (BMI) greater than 35
* Anticipation of surgery involving any joint of either lower extremity in the next 3 years
* Habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
* Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
* Chronic infection in any joint of the lower extremities
* History of fracture of either lower extremity within 6 months of study entry
* History of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
* History of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
* Pregnancy
* Any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol
25 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Rush University Medical Center
OTHER
Responsible Party
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Rush University Medical Center
Principal Investigators
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Joel A. Block, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center, Section of Rheumatology
Locations
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Rush University Medical Center, Section of Rheumatology
Chicago, Illinois, United States
Countries
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References
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Tezcan ME, Goker B, Lidtke R, Block JA. Long-term effects of lateral wedge orthotics on hip and ankle joint space widths. Gait Posture. 2017 Jan;51:36-40. doi: 10.1016/j.gaitpost.2016.09.017. Epub 2016 Sep 21.
Other Identifiers
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NIAMS-116
Identifier Type: -
Identifier Source: org_study_id