None listed
Conditions
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 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.
Interventions
This comparative effectiveness trial will compare two different classes of footwear:
Flat flexible shoes- selected from commercially available footwear, that fulfill previously published criteria for flat flexible shoes (Paterson et al, 2017, Osteoarthritis & Cartilage). These criteria are: 1) heel height of less than 15mm; 2) shoe pitch of less than 10mm; 3) absence of arch support or motion control; 4) have "minimal" rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh 200g or less
This comparative effectiveness trial will compare two different classes of footwear: Flat flexible shoes- selected from commercially available footwear, that fulfill previously published criteria for flat flexible shoes (Paterson et al, 2017, Osteoarthritis & Cartilage). These criteria are: 1) heel height of less than 15mm; 2) shoe pitch of less than 10mm; 3) absence of arch support or motion control; 4) have "minimal" rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh 200g or less (+/-10%). Measurements are based on a size 9 US Men's and size 9 US Women's. Participants in this group will choose two pairs of shoes from a selection of available shoes that fulfil the above criteria. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement will cease to be available during the course of the trial, or will be relaunched/rebranded with a different shoe name. In such instances, shoes will be replaced by a similar pair of commercially available shoes that fulfil the listed criteria. Stable supportive shoes- selected from commercially available footwear, that fulfil previously published criteria for stable supportive shoes (Paterson et al, 2017,Osteoarthritis & Cartilage). These criteria are: 1) heel height of greater than 30mm; 2) shoe pitch of greater than 10mm; 3) presence of arch support or motion control; 4) have "rigid" rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh more than 300g (+/-10%). Measurements are based on a size 9 US Men's and size 9 US Women's. Participants in this group will choose two pairs of shoes from a selection of available shoes that fulfil the above criteria. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement will cease to be available during the course of the trial, or will be relaunched/rebranded with a different shoe name. In such instances, shoes will be replaced by a similar pair of commercially available shoes that fulfil the listed criteria. The shoes will be provided at the University of Melbourne Human Movement Laboratory by one of the researchers experienced in the fitting shoes for participants in a randomized controlled trial. Participants will be asked to wear any combination of their 2 pairs of study shoes for at least 6 hours per day for the study duration of 6 months. Participants will be provided with an information sheet regarding how to get used to wearing the shoes and will also 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).
Sponsors
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 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
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; 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).
Outcome results
None listed