We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00076453
Recruitment Status : Completed
First Posted : January 26, 2004
Last Update Posted : September 27, 2011
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
Rush University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Device: Lateral wedge orthotic shoe inserts Device: Standard orthotic shoe inserts Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Pain reduction [ Time Frame: Years 2 and 3 ]

Secondary Outcome Measures :
  1. Reduction in loading of the medial knee [ Time Frame: Years 2 and 3 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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

Layout table for location information
United States, Illinois
Rush University Medical Center, Section of Rheumatology
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Layout table for investigator information
Principal Investigator: Joel A. Block, MD Rush University Medical Center, Section of Rheumatology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Joel A. Block, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00076453    
Other Study ID Numbers: NIAMS-116
2P50AR039239-16 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2004    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011
Keywords provided by Rush University Medical Center:
Knee Pain
Degenerative Arthritis
Cartilage Disease
Non-drug Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases