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NCT00032240 Clinical Trial

Shoe Inserts for Treating Osteoarthritis of the Knee

Osteoarthritis, Knee Clinical Trial

Official title:
Randomized Trial of a Wedged Insole for Treatment of Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00032240
Other study ID # P60AR047785
Secondary ID P60AR047785NIAMS
Status Completed
Phase Phase 3
First received March 12, 2002
Last updated June 2, 2013
Start date February 2002
Est. completion date August 2006

Study information
Verified date June 2013
Source Boston University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be studied.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 85 Years
Eligibility Inclusion Criteria:

- Medial knee osteoarthritis

- Pain

- No foot problems

- Lives in Boston, Massachusetts Metro area

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Shoe Insert

Locations
Country Name City State
United States Boston University Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Boston University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Goggins J, Baker K, Felson D. What WOMAC pain score should make a patient eligible for a trial in knee osteoarthritis? J Rheumatol. 2005 Mar;32(3):540-2. — View Citation

Kerrigan DC, Lelas JL, Goggins J, Merriman GJ, Kaplan RJ, Felson DT. Effectiveness of a lateral-wedge insole on knee varus torque in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2002 Jul;83(7):889-93. — View Citation

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