None listed
Conditions
Brief summary
Chronic hip pain is a highly prevalent condition that is largely due to osteoarthritis (OA). Hip OA affects around 40 million people globally and is a leading cause of years lived with disability. With an ageing population and rising rates of obesity, the condition is projected to increase by 58% in Australia over the next decade, leading to substantial societal and health care burden. As hip OA has no cure, advice on self-management of symptoms is recommended as a core treatment component for all patients with hip OA. Currently, footwear guidelines for people with hip OA are based solely on expert opinion, and no research has investigated which type of shoes are most effective at reducing symptoms in people with chronic hip pain. We are conducting a research study to compare two classes of readily available off-the-shelf shoes on individual's self-reported hip pain. 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 chronic hip pain 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.
The intervention treatment category is 'stable supportive shoes'. The stable supportive shoes were 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
This comparative effectiveness trial will compare two different classes of footwear. The intervention treatment category is 'stable supportive shoes'. The stable supportive shoes were 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" sole rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh more than 300g (+/-10%). Participants will choose two pairs of shoes from a selection of available shoes that fulfil the above criteria for stable supportive shoes. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement may cease to be available during the course of the trial, or may 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
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. aged greater than or equal to 45 years; b. activity-related hip joint pain; and c. either no morning hip joint stiffness or stiffness that lasts no longer than 30 minutes; ii) report history of hip pain of at least 3 months duration; iii) report hip pain on most days of the past month; iv) report a minimum hip pain score of 4 out of 10 on an 11-point NRS (terminal descriptors of ‘no pain’ and ‘worst pain possible’) during walking over the previous week.
Exclusion criteria
i) diagnosed in the past 12 months by a health professional as having gluteal tendinopathy, greater trochanteric pain syndrome, referred hip pain from the lumbar spine or femoro-acetabular impingement syndrome; ii) recent hip surgery (past 6 months) or planned surgery in next 6 months; iii) current use of shoe orthoses, customized shoes or brace (on any joint of lower limb); iv) current regular use of high heels, thongs or work boots that would restrict ability to wear allocated trial shoes 6 hours/day; v) had any hip injection in the past 3 months or planning an injection in next 6 months; vi) self-report other muscular or joint condition anywhere in the body which is worse than study hip pain; vii) self-report any systemic or inflammatory joint disease (e.g. fibromyalgia, rheumatoid arthritis, gout); viii) any neurological condition affecting the spine or either lower limb; ix) current or planned use of a gait aid in the next 6 months; x) inability to understand written/spoken English; and xi) unable to commit to 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). xii) hip replacement on the most painful side
Outcome results
None listed