Wedged Insoles for Management of Knee Osteoarthritis

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.

Conditions

• Knee Osteoarthritis

Interventions

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Natural Sciences and Engineering Research Council, Canada

  collaborator OTHER

• Alberta Innovates Health Solutions

  collaborator OTHER

• Killam Trusts

  collaborator UNKNOWN

• New Balance Athletic Shoe, Inc.

  collaborator INDUSTRY

• University of Calgary

  lead OTHER

Principal Investigators

• Ryan T Lewinson, BSc · University of Calgary

• Kelsey HM Collins, BS · University of Calgary

• Isabelle A Vallerand, BSc · University of Calgary

• J Preston Wiley, MD, MPE · University of Calgary

• Linda J Woodhouse, PhD, PT · University of Alberta

• Raylene A Reimer, PhD · University of Calgary

• Jay T Worobets, PhD · University of Calgary

• Walter Herzog, PhD · University of Calgary

• Darren J Stefanyshyn, PhD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-10-31

Completion

2015-11-30

Countries

• Canada

Study Locations