None listed
Conditions
Brief summary
Patellofemoral pain is experienced by one in four adolescents. This pain is debilitating, leads to reduced quality of life and decreased participation in physical activity. Adolescent patellofemoral pain persists into adulthood, with up to 78% continuing to experience pain up to 20 years later. A longer duration of patellofemoral pain is the most consistent predictor of poor prognosis, highlighting the need to intervene early. We know very little about how to effectively manage patellofemoral pain in adolescents. Evidence-based treatments that are effective in adults, such as exercise therapy, are not as effective in adolescent populations. Adolescents spend up to nine hours per weekday in stiff, raised heel school shoes whilst performing a significant amount of their daily physical activity. Stiff, raised heel shoes are known to elevate patellofemoral joint loads. Flat, flexible footwear have been shown to reduce patellofemoral joint loads. This is a simple, low-cost treatment option that directly targets repetitive patellofemoral joint loading known to contribute to pain in adolescents. This trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating flat, flexible school shoes for adolescents with patellofemoral pain. Findings will inform future large-scale clinical trials and guide clinical practice guidelines for management of adolescent patellofemoral pain.
Interventions
Flat, flexible shoes:
Participants will receive a commercially available flat flexible shoe that conforms to school uniform guidelines (e.g. Vivobarefoot Primus Lite or RA II). The shoe will be lightweight, have minimal stability features, a low stack height and no heel-toe offset. Participants will attend a 30 minute baseline session with research staff to have the shoes individually fitted. Participants will wear this shoe as per school requirements throughout the 12-week intervention period.
Flat, flexible shoes: Participants will receive a commercially available flat flexible shoe that conforms to school uniform guidelines (e.g. Vivobarefoot Primus Lite or RA II). The shoe will be lightweight, have minimal stability features, a low stack height and no heel-toe offset. Participants will attend a 30 minute baseline session with research staff to have the shoes individually fitted. Participants will wear this shoe as per school requirements throughout the 12-week intervention period. A graduated exposure to the shoe based on days per week will be used. Participants will be instructed to wear the shoes for 2 school days in the first week, 3 school days in weeks 2-3, and every day that school shoes are worn in weeks 4-12 (except for sports uniform day). Written instructions for this exposure and adaption, specific to this study, will be provided. Participants will be asked to record their daily hours of wear in a weekly logbook.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
(i) Aged 12-18 years; (ii) anterior knee pain of non-traumatic origin for at least 6 weeks duration; (iii) pain that is rated at least 3 on an 11-point numerical rating scale (0=no pain, 10=maximal pain); and (iv) knee pain aggravated by activities that load the patellofemoral joint (e.g. squatting, stair climbing)
Exclusion criteria
(i) Concomitant pain at sites other than the anterior knee; (ii) history of knee, hip or spine surgery, or other suspected knee joint pathology (e.g. Osgood Schlatter’s Disease); (iii) planned lower limb surgery (e.g. arthroscopy); (iv) neurological condition or systemic arthritis; (v) currently wearing a flat,flexible shoe for school; and (vi) any foot condition precluding the use of flat, flexible shoes.
Outcome results
None listed