RecruitingNot ApplicableNCT06251167

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

A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis

Sponsor

University of British Columbia

Enrollment

31 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis

Summary

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This multi-centre pilot study is testing whether custom shoe insoles (orthotics) can reduce knee pain and also affect foot pain in people with medial knee osteoarthritis — since many people with knee arthritis also experience foot pain, it's important to understand the effects at both joints. Researchers will randomly assign participants to use different types of insoles and track pain and movement outcomes. Adults with medial knee osteoarthritis confirmed by X-ray, at least 6 months of knee pain averaging 3 or more out of 10, and foot pain in the same limb as the affected knee are eligible — those with lateral knee arthritis, recent injections, systemic arthritis, or who are already using insoles are not eligible. Participation involves an initial biomechanical assessment, wearing the assigned insoles for several weeks, and completing questionnaires about pain and function. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELateral wedge insoles (LWIs)

Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge.

DEVICELateral wedge plus custom arch support (LWAS)

Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then uploads this foot data to a secure patient record system that is used for insole fabrication. The LWAS insoles will be comprised of variable density material (more dense laterally than medially) and milled directly to produce a full-length shell. The 6 degree wedge will be incorporated along the full lateral length of the insoles.