Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2014-10-31
2015-11-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
40 Years
85 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Natural Sciences and Engineering Research Council, Canada
OTHER
Alberta Innovates Health Solutions
OTHER
Killam Trusts
UNKNOWN
New Balance Athletic Shoe, Inc.
INDUSTRY
University of Calgary
OTHER
Responsible Party
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Ryan Lewinson
MD/PhD Candidate
Principal Investigators
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Ryan T Lewinson, BSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Kelsey HM Collins, BS
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Isabelle A Vallerand, BSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
J Preston Wiley, MD, MPE
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Linda J Woodhouse, PhD, PT
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Raylene A Reimer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Jay T Worobets, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Walter Herzog, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Darren J Stefanyshyn, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Human Performance Laboratory, University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Lewinson RT, Vallerand IA, Collins KH, Wiley JP, Lun VMY, Patel C, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee adduction moments for management of knee osteoarthritis:: A three month phase I/II randomized controlled trial. Gait Posture. 2016 Oct;50:60-68. doi: 10.1016/j.gaitpost.2016.08.027. Epub 2016 Aug 26.
Lewinson RT, Collins KH, Vallerand IA, Wiley JP, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 3;15:405. doi: 10.1186/1471-2474-15-405.
Other Identifiers
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23731-01
Identifier Type: -
Identifier Source: org_study_id