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Clinical Trials/NCT02234895
NCT02234895
Completed
Not Applicable

Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis

University of British Columbia1 site in 1 country26 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of British Columbia
Enrollment
26
Locations
1
Primary Endpoint
Change in knee joint load during walking: knee adduction moment
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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

  • Change in Self-Reported Physical Function(Baseline and 2 Months)
  • Change in Foot Pain(Baseline and 2 Months)

Study Sites (1)

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