Wedged Insoles for Management of Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: wedged insole
- Registration Number
- NCT02067208
- Lead Sponsor
- University of Calgary
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental wedged insole wedged insole Either a medially wedged or laterally wedged footwear insole (whichever reduces knee joint mechanical loading more, as determined from subject-specific biomechanical tests), constructed using a 3D printer will be inserted into each participant's shoe. The participant will be asked to utilize this insole as much as possible throughout the day over the course of 3 months.
- Primary Outcome Measures
Name Time Method KOOS pain score baseline, 1-month, 2-months, 3-months Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection
- Secondary Outcome Measures
Name Time Method Footwear Comfort baseline Evaluated using 100mm visual analog scale
PASE score baseline, 1-month, 2-months, 3-months Physical Activity Scale for the Elderly (PASE)
Knee biomechanics baseline Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse).
UCLA Physical Activity Score baseline, 1-month, 2-months, 3-months Scale evaluating physical activity levels
Knee Adduction Moment baseline Calculated using inverse dynamics
Adiposity baseline Measured using Dual Energy X-Ray Absorptiometry (DXA) scan
KOOS subsection and aggregate scores baseline, 1-month, 2-months, 3-months All other KOOS sections (excluding pain, which is primary outcome)
Trial Locations
- Locations (1)
Human Performance Laboratory, University of Calgary
🇨🇦Calgary, Alberta, Canada