Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06251167

A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

Led by University of British Columbia · Updated on 2025-03-25

36

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

W

Western University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.

CONDITIONS

Official Title

A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Medial tibiofemoral osteoarthritis confirmed by X-rays showing osteophytes and joint space narrowing in the medial knee compartment
  • History of knee pain lasting longer than 6 months
  • Average self-reported knee pain of at least 3 out of 10 over the past 6 months
  • Pain present in the same foot or feet as the painful knee or knees
  • Ability to communicate in English
  • Demonstrated immediate biomechanical response to the insoles during assessment
Not Eligible

You will not qualify if you...

  • Radiographic evidence of more lateral tibiofemoral osteoarthritis than medial
  • Knee surgery or intra-articular injection within the previous 6 months
  • Use of corticosteroids within the last 6 months for any reason
  • Presence of a systemic arthritic condition
  • History of knee joint replacement or tibial osteotomy
  • Any other condition that affects lower limb function
  • Current use of shoe-worn insoles or plans to obtain footwear modifications in the next 6 months
  • Previous experience with insoles that caused increased lower limb pain or led to stopping use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Motion Analysis and Biofeedback Laboratory

Vancouver, British Columbia, Canada, V5R 3N9

Actively Recruiting

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Research Team

N

Natasha Krowchuk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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