Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Cartilage, Musculoskeletal, Biomechanics, Subtype, Footwear, Orthotics, Joint Loading
Brief summary
Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these insoles typically reduce knee abduction moments (KAM) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for OA management, recent research has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In such cases, a medial wedge may be more appropriate. The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months for patients with knee OA. It is hypothesized that pain reduction will be directly related to KAM reduction. Forty-six participants with knee OA will be recruited to participate. Each will undergo biomechanical gait analysis to determine the wedge type that most greatly reduces knee adduction moments. In addition, each participant will undergo a Dual Energy X-Ray Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury history. Participants will be randomized into either a wait list control group (no insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months. Changes to pain, function, comfort and physical activity from baseline to 3 months will be assessed within the control and experimental groups. Regression analyses will be conducted on the experimental group to determine if a relationship exists between reduced KAMs and reduced pain over 3 months. Comparisons will also be made between the control and experimental groups.
Interventions
DEVICEwedged insole
Wedged insoles are designed to reduce frontal plane knee joint mechanical loads during gait. Specifically, they can alter the knee adduction moment during gait - a variable associated with progression of knee osteoarthritis. In the experimental arm of this study, participants will undergo biomechanical gait analysis to identify the wedged insole that reduces the moments the most. The two options are medial wedge, where the medial aspect of the foot is elevated relative to the lateral aspect, and the lateral wedge, where the lateral wedge is elevated relative to the medial aspect.
Sponsors
Canadian Institutes of Health Research (CIHR)
Natural Sciences and Engineering Research Council, Canada
Alberta Innovates Health Solutions
Killam Trusts
New Balance Athletic Shoe, Inc.
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed knee osteoarthritis (using American College of Rheumatology clinical and radiographic criteria) * Kellgren-Lawrence grade 1, 2, 3 or 4 * Primary symptoms and disease location must be attributed to medial tibiofemoral compartment * KOOS pain of 75 points or lower (where 0 is worst pain and 100 is no pain)
Exclusion criteria
* X-ray older than 2 years * Viscosupplementation within past 6 months * Cortisone injection in past 3 months * Narcotic pain medication within past 3 months * Use of knee unloading brace interventions in past 2 months * Recent (past 6 months) knee or neuromuscular injury that could bias pain assessments or gait analysis results * No KAM reduction with either lateral or medial wedge insole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS pain score | baseline, 1-month, 2-months, 3-months | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee biomechanics | baseline | Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse). |
| PASE score | baseline, 1-month, 2-months, 3-months | Physical Activity Scale for the Elderly (PASE) |
| UCLA Physical Activity Score | baseline, 1-month, 2-months, 3-months | Scale evaluating physical activity levels |
| Adiposity | baseline | Measured using Dual Energy X-Ray Absorptiometry (DXA) scan |
| Footwear Comfort | baseline | Evaluated using 100mm visual analog scale |
| KOOS subsection and aggregate scores | baseline, 1-month, 2-months, 3-months | All other KOOS sections (excluding pain, which is primary outcome) |
| Knee Adduction Moment | baseline | Calculated using inverse dynamics |
Countries
Canada
Outcome results
None listed