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A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain Clinical research trials and A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain. A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain clinical trial. Test subjects typically receive the most expert healthcare available for their A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain  A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
For Condition: Osteoarthritis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 25 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Able and willing to give informed consent and to comply with the study protocol and follow-up instructions - Symptomatic and radiographic OA of the knee - Knee pain upon walking - Predominant medial compartment OA Exclusion Criteria - Knee flexion contracture of greater than 15 degrees or inability to walk without assistance - 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
JoelBlock, Principal Investigator, Rush University Medical Center, Section of Rheumatology
Rush University Medical Center, Section of Rheumatology *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Rita Tharpe 312-563-2956
Additional Information:
Study ID Numbers: NIAMS-116; 2P50 AR39239-16
Study Start Date: June 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076453
Other Osteoarthritis Studies:
1. Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
2. Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis
3. Osteoarthritis Initiative (OAI): A Knee Health Study
4. Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
5. Effects of Comprehensive Care for Knee OA
Related Studies:
Other Osteoarthritis Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
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