None listed
Conditions
Brief summary
We are conducting a clinical trial to compare two different classes of footwear for managing adolescent kneecap pain. The participants will wear their allocated study shoes during all planned sport and exercise based activities over a 3 month period. The two different treatment groups in this study are: 1. Flat flexible shoes 2. Stable supportive shoes We will evaluate the effectiveness of the different footwear classes on pain and physical function at 3 months. Primary and secondary outcomes will be collected via online survey at baseline and 3 months. Our hypothesis is that flat flexible shoes, which have been shown to reduce kneecap loading in adolescents, will result in a greater improvement in kneecap pain for adolescents.
Interventions
This comparative effectiveness trial will compare two different classes of footwear.
The intervention treatment category is minimalist shoes. The minimalist shoes were selected from commercially available footwear, that fulfill previously published criteria for minimalist 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" sole rigidity (Ba
This comparative effectiveness trial will compare two different classes of footwear. The intervention treatment category is minimalist shoes. The minimalist shoes were selected from commercially available footwear, that fulfill previously published criteria for minimalist 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" sole 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 will choose a pair of shoes from a selection of available colours. The shoes will fulfil the above criteria for minimalist 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. The laboratory session, which includes shoe fitting and biomechanical testing, will last approximately 90 minutes. Participants will be asked to wear their study shoes for all planned sport and exercise-based activities for the study duration of 3 months. Participants will be provided with an information sheet regarding how to get used to wearing the shoes and will also complete a logbook for one week per month (the fourth week of the month). Both documents have been specifically designed for this study. The information sheet advises that participants should begin wearing their shoes for 1-2 hours on the first day during non-sporting activities, then gradually increase their wear time over subsequent days until the shoes are comfortable. At this point the participants can begin wearing their shoes during all planned sport and exercise-based activities. In the logbooks, participants will report how much they wore their shoes during all planned sport and exercise based activities for each day of that week. Additionally, a temperature microsensor will be embedded within the shoe to determine wear time. The data from the shoe temperature sensor will be collected at the end of the 3 month intervention period and provide accurate data on shoe wear time for each day
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
12 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
i) adolescents aged 12 to 19 years, ii) participate in planned sport and exercise-based activities that load the patellofemoral joint for at least 60 minutes per week, iii) participate in planned sport and exercise-based activities that load the patellofemoral joint and that cause knee pain either during or after that is greater than or equal to 3 on an 11-point numerical rating scale (0 no pain; 10 = worst pain imaginable), iv) report pain in or around the front of the knee that is aggravated by at least one activity that loads the patellofemoral joint during weightbearing, including squatting, stair climbing, running, hopping, jumping, v) have a history of knee pain for greater than or equal to 2 months.
Exclusion criteria
i) attending primary school, ii) a history of patellar dislocation, iii) traumatic onset of knee symptoms, iv) recent knee surgery in the past 6 months or planned surgery in next 3 months, v) unable to wear study footwear during sport and exercise activities, vi) current use of shoe orthoses, vii) diagnosed in the past 12 months by a health professional as having a knee condition other than patellofemoral pain, viii) self-report other muscle or joint condition anywhere in the body which is worse than study knee pain, ix) self-report any systemic or inflammatory joint disease (e.g., juvenile idiopathic arthritis), x) any neurological condition affecting the spine or either lower limb, and xi) inability to understand written/spoken English. xii) unable to commit to study requirements (eg wearing shoes, attending appointments, completing outcomes, do not have foot size in the range of 7 to 13 US for men, and 6 to 11US for women).
Outcome results
None listed