Shoe Modification and Knee Osteoarthritis



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - 85
Updated:4/21/2016
Start Date:March 2004
End Date:September 2005

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This trial will assess the ability of shoe inserts to relieve pain and disability in people
with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.

Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain
and disability. Its prevalence increases with age, leading to about 65-85% of those age 65
years and older having OA. Involvement of the knee with OA is the main reason for
significant functional impairment as it alters ambulation through pain and stiffness.
Nonpharmacological management of knee OA includes the use of orthotic supports such as
wedged insoles for varus or valgus knee deformities to relieve pain and improve function in
the early stages of this joint disease. Although these interventions are desirable because
they are simple and inexpensive, we do not have a clear understanding about their efficacy
in relieving pain and disability in people with knee OA. We also do not know whether there
is a relationship between changes in joint biomechanics that occur with wedged insoles and
changes in function and progression of OA. Furthermore, information is lacking regarding
which patients would benefit from wedged insoles. Answering these questions will be
critically important in the development of guidelines for the prescription of wedged insoles
in knee OA. Patients in this study will be evaluated at baseline and after wearing the
lateral-wedged insoles immediately and after wearing the insoles for four weeks. The
participants will wear lateral-wedged insoles for the painful knee(s) for as many hours and
for as many days of the week as they can tolerate. Some subjects may use a neutral position
insole for an asymptomatic knee.

Inclusion Criteria:

- Ability to walk 30 feet without a walking aid

- Ability to stand unaided

- Ability to understand verbal instructions

- Ability to give informed consent

Exclusion Criteria:

- History of knee trauma or surgery including arthroscopic surgery in the past 6 months

- Severe obesity (>30 kg/m2)

- Neurological disease

- Injury or amputation to the lower extremity joints

- History of other types of arthritis

- Symptomatic spine, hip, ankle, or foot disease that would interfere with assessment
of the knee

- Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6
months

- Poor health that would impair compliance or assessment such as shortness of breath
with exertion
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