Wedged Insoles for Management of Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02067208|
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : December 2, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: wedged insole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||November 2015|
No Intervention: Waitlist Control
A waitlist control condition, where the participant receives no insole for 3 months. During this 3 month period, the participant will continue to be monitored for outcome variables.
Experimental: Experimental 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.
Device: wedged 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.
Other Name: orthotic
- KOOS pain score [ Time Frame: baseline, 1-month, 2-months, 3-months ]Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection
- Adiposity [ Time Frame: baseline ]Measured using Dual Energy X-Ray Absorptiometry (DXA) scan
- Knee biomechanics [ Time Frame: baseline ]Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse).
- PASE score [ Time Frame: baseline, 1-month, 2-months, 3-months ]Physical Activity Scale for the Elderly (PASE)
- UCLA Physical Activity Score [ Time Frame: baseline, 1-month, 2-months, 3-months ]Scale evaluating physical activity levels
- Knee Adduction Moment [ Time Frame: baseline ]Calculated using inverse dynamics
- Footwear Comfort [ Time Frame: baseline ]Evaluated using 100mm visual analog scale
- KOOS subsection and aggregate scores [ Time Frame: baseline, 1-month, 2-months, 3-months ]All other KOOS sections (excluding pain, which is primary outcome)
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|Ages Eligible for Study:||40 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
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): NCT02067208
|Human Performance Laboratory, University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Ryan T Lewinson, BSc||University of Calgary|
|Principal Investigator:||Kelsey HM Collins, BS||University of Calgary|
|Principal Investigator:||Isabelle A Vallerand, BSc||University of Calgary|
|Principal Investigator:||J Preston Wiley, MD, MPE||University of Calgary|
|Principal Investigator:||Linda J Woodhouse, PhD, PT||University of Alberta|
|Principal Investigator:||Raylene A Reimer, PhD||University of Calgary|
|Principal Investigator:||Jay T Worobets, PhD||University of Calgary|
|Principal Investigator:||Walter Herzog, PhD||University of Calgary|
|Principal Investigator:||Darren J Stefanyshyn, PhD||University of Calgary|
|Responsible Party:||Ryan Lewinson, MD/PhD Candidate, University of Calgary|
|Other Study ID Numbers:||
|First Posted:||February 20, 2014 Key Record Dates|
|Last Update Posted:||December 2, 2015|
|Last Verified:||November 2015|