Skip to main content
OpenTrials
Completed

NCT Number: NCT02234895

Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis

Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. One such treatment is the use of orthotics to reduce pain and increase function in people with knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and contradictory, and could benefit from more research taking into account foot posture. This study aims to compare the use of two orthotics designs in people with knee OA.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia; University Hospital

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)

ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment

iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.

Exclusion criteria

i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response

ii) knee surgery or intra-articular corticosteroid injection within the previous six months

iii) current or recent (within 4 weeks) oral corticosteroid use

iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months

v) ankle/foot pathology or pain that precludes the use of orthotics

vi) current use of foot orthotics

vii) use of footwear unable to accommodate an orthotic

viii) unable to walk without a gait aid

ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)

Treatment and study plan

Lateral wedge

Device

This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.

Lateral wedge plus medial arch support

Device

This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.

Primary outcomes

  1. Change in knee joint load during walking: knee adduction moment

    Time frame: Baseline and 2 months

    Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected.

    The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.

  2. Change in Knee Pain

    Time frame: Baseline and 2 Months

    The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.

Secondary outcomes

  1. Change in Self-Reported Physical Function

    Time frame: Baseline and 2 Months

    The physical function subscale (17 questions) on the WOMAC will be used.

  2. Change in Foot Pain

    Time frame: Baseline and 2 Months

    Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form). This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation. Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies

Other outcomes

  1. Participant perceived response to treatment

    Time frame: 2 Months

    At follow-up for each orthotic, participants will rate overall perceived change in pain and physical function (vs. baseline) on an ordinal scale (1-much worse, 2-slightly worse, 3-same, 4-slightly better, 5-much better). This will be dichotomized into 'improvement' (4 and 5) or 'no improvement'

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Kintec Footlabs
  • Pedorthic Research Foundation of Canada

Registry information

Official study title

Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2014
Registry last updated
Jun 8, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.