FOLK BMJ Open 2022

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Rana Hinman

Brief Summary

We are conducting a research study to compare the effects of daily use of motion-control and neutral walking shoes on lateral tibiofemoral osteoarthritis clinical outcomes, over 6 months. To do this we will randomly allocate participants to receive either i) motion-control or; ii) neutral walking shoes. Participants will be provided a pair of shoes from their allocated group, to be worn daily for 6 months (minimum of 6 hours/day).

Key Inclusion Criteria

i) aged 50 years or older; 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 Grade 2-4 tibiofemoral osteoarthritis on x-ray as determined by the Kellgren & Lawrence grading system; and v) demonstrate grade of lateral tibiofemoral joint space narrowing greater than medial tibiofemoral joint space narrowing according to a radiographic atlas (where Grade 0=no narrowing .... i) aged 50 years or older; 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 Grade 2-4 tibiofemoral osteoarthritis on x-ray as determined by the Kellgren & Lawrence grading system; and v) demonstrate grade of lateral tibiofemoral joint space narrowing greater than medial tibiofemoral joint space narrowing according to a radiographic atlas (where Grade 0=no narrowing, 1=mild narrowing, 2=moderate narrowing, 3=severe narrowing).
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Key Exclusion Criteria

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