None listed
Conditions
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).
Interventions
This pragmatic comparative effectiveness trial will compare two different types of walking shoes manufactured by Asics.
Following baseline assessment, participants will be randomly allocated 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), after which participants will be reassessed remotely via paper or web-based questionnaires.
Motion-control s
This pragmatic comparative effectiveness trial will compare two different types of walking shoes manufactured by Asics. Following baseline assessment, participants will be randomly allocated 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), after which participants will be reassessed remotely via paper or web-based questionnaires. Motion-control shoes: These shoes feature a dual density motion control mid-sole that is stiffer medially compared to laterally (Duomax). Versus: Neutral walking shoes: These shoes have a mono-density mid-sole (i.e. equal medial and lateral stiffness). Participants will complete a log book once per month, where they will record the number of hours each day they wore each pair of their study shoes for a one-week period (the fourth week of the month). At the end of the intervention period, participants will rate their overall level of adherence using a numerical rating scale (0= shoes not worn at all to 10= shoes worn completely as instructed).
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
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, 1=mild narrowing, 2=moderate narrowing, 3=severe narrowing).
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 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).
Outcome results
None listed