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NCT Number: NCT02067208

Wedged Insoles for Management of Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Performance Laboratory, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wedged insole

Device

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

Primary outcomes

  1. KOOS pain score

    Time frame: baseline, 1-month, 2-months, 3-months

    Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection

Secondary outcomes

  1. Adiposity

    Time frame: baseline

    Measured using Dual Energy X-Ray Absorptiometry (DXA) scan

  2. Knee biomechanics

    Time frame: baseline

    Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse).

  3. PASE score

    Time frame: baseline, 1-month, 2-months, 3-months

    Physical Activity Scale for the Elderly (PASE)

  4. UCLA Physical Activity Score

    Time frame: baseline, 1-month, 2-months, 3-months

    Scale evaluating physical activity levels

  5. Knee Adduction Moment

    Time frame: baseline

    Calculated using inverse dynamics

  6. Footwear Comfort

    Time frame: baseline

    Evaluated using 100mm visual analog scale

  7. KOOS subsection and aggregate scores

    Time frame: baseline, 1-month, 2-months, 3-months

    All other KOOS sections (excluding pain, which is primary outcome)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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