FOOTSTEP Paterson 2021

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Rana Hinman

Brief Summary

Knee osteoarthritis is a major problem in Australia and there is no cure for the disease. Non-drug strategies that help people to self-manage the condition are needed. Different types of shoes influence forces acting across the knee joint. We know that increased knee forces can contribute to the knee pain associated with knee osteoarthritis, and that high forces can increase the risk of the disease worsening over time. It is recommended that clinicians provide advice on “appropriate” footwear fo .... Knee osteoarthritis is a major problem in Australia and there is no cure for the disease. Non-drug strategies that help people to self-manage the condition are needed. Different types of shoes influence forces acting across the knee joint. We know that increased knee forces can contribute to the knee pain associated with knee osteoarthritis, and that high forces can increase the risk of the disease worsening over time. It is recommended that clinicians provide advice on “appropriate” footwear for people with knee osteoarthritis. However, there is little evidence from clinical trials to determine which shoes are best for self-managing knee osteoarthritis. We are conducting a research study to compare two classes of readily available off-the-shelf shoes on knee osteoarthritis symptoms. To do this, we will allocate people via a random process into two different groups. Participants in each group will be provided with 2 pairs of different shoes to wear daily for 6 months. To ensure that this is a fair and unbiased evaluation, we will not disclose the differences in the shoe classes between the two groups until the end of the study. There will be an equal number of participants in each group, and participants will not be able to choose which group they are in. The findings of this study will help determine which shoes are best for people with knee osteoarthritis and will guide clinicians in providing appropriate evidence-based footwear advice for their patients. The findings of this study will be published in medical journals and be presented at conferences.
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Key Inclusion Criteria

i) aged greater than or equal to 50 years; ii) report knee pain on most days of the past month; iii) report a minimum pain score of 4 on an 11-point numeric rating scale during walking over the previous week; iv) demonstrate tibiofemoral osteophytes on x-ray; and v) demonstrate moderate-severe (Grade 3-4) tibiofemoral OA on x-ray as determined by the Kellgren & Lawrence grading system

Key Exclusion Criteria

i) Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray; ii) suffered knee pain for <3 months; iii) recent knee surgery (past 6 months) or planned surgery in next 6 months; iv) current use of shoe orthoses, customized shoes or ankle braces; v) current primary use of high heels, thongs or work boots that would restrict ability to wear study shoes 6 hours/day; vi) had a hip or knee replacement on either side; vii) had a high tibial osteotomy on either leg; v .... i) Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray; ii) suffered knee pain for <3 months; iii) recent knee surgery (past 6 months) or planned surgery in next 6 months; iv) current use of shoe orthoses, customized shoes or ankle braces; v) current primary use of high heels, thongs or work boots that would restrict ability to wear study shoes 6 hours/day; vi) had a hip or knee replacement on either side; vii) had a high tibial osteotomy on either leg; viii) had any knee injections in the past 3 months or planned injections in next 6 months; ix) self-report any other muscular, joint or neurological condition affecting lower limb function; x) self-report any systemic or inflammatory joint disease (eg rheumatoid arthritis); xi) current or planned use of a gait aid in the next 6 months xii) inability to understand written/spoken English xiii) unable to fulfill study requirements (eg wearing shoes, attending appointments, completing outcomes, do not have foot size in the range of 8 to 13US for men, and 7 to 12US for women).
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