Wedged Insoles for Management of Knee Osteoarthritis

November 30, 2015 updated by: Ryan Lewinson, University of Calgary

Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Human Performance Laboratory, University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • orthotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS pain score
Time Frame: baseline, 1-month, 2-months, 3-months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection
baseline, 1-month, 2-months, 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiposity
Time Frame: baseline
Measured using Dual Energy X-Ray Absorptiometry (DXA) scan
baseline
Knee biomechanics
Time Frame: baseline
Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse).
baseline
PASE score
Time Frame: baseline, 1-month, 2-months, 3-months
Physical Activity Scale for the Elderly (PASE)
baseline, 1-month, 2-months, 3-months
UCLA Physical Activity Score
Time Frame: baseline, 1-month, 2-months, 3-months
Scale evaluating physical activity levels
baseline, 1-month, 2-months, 3-months
Knee Adduction Moment
Time Frame: baseline
Calculated using inverse dynamics
baseline
Footwear Comfort
Time Frame: baseline
Evaluated using 100mm visual analog scale
baseline
KOOS subsection and aggregate scores
Time Frame: baseline, 1-month, 2-months, 3-months
All other KOOS sections (excluding pain, which is primary outcome)
baseline, 1-month, 2-months, 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)
Alberta Innovates Health Solutions
Natural Sciences and Engineering Research Council, Canada
Killam Trusts
New Balance Athletic Shoe, Inc.

Investigators

  • Principal Investigator: J Preston Wiley, MD, MPE, University of Calgary
  • 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23731-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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