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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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Natural Sciences and Engineering Research Council, Canada
Alberta Innovates Health Solutions
Killam Trusts
New Balance Athletic Shoe, Inc.
Information provided by (Responsible Party):
Ryan Lewinson, University of Calgary

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: wedged insole Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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 Name: orthotic


Outcome Measures
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Primary Outcome Measures :
  1. KOOS pain score [ Time Frame: baseline, 1-month, 2-months, 3-months ]
    Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Alberta
Human Performance Laboratory, University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Natural Sciences and Engineering Research Council, Canada
Alberta Innovates Health Solutions
Killam Trusts
New Balance Athletic Shoe, Inc.
Investigators
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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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ryan Lewinson, MD/PhD Candidate, University of Calgary
ClinicalTrials.gov Identifier: NCT02067208    
Other Study ID Numbers: 23731-01
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Ryan Lewinson, University of Calgary:
Osteoarthritis
Cartilage
Musculoskeletal
Biomechanics
 Subtype
Footwear
Orthotics
Joint Loading
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases