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HAPPi Kneecaps! A feasibility trial of shoe inserts for adolescents with patellofemoral pain

HAPPi Kneecaps! A feasibility trial of shoe inserts for adolescents with patellofemoral pain

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000957190
Acronym
HAPPi Kneecaps! (sHoe inserts for Adolescents with Patellofemoral PaIn)
Enrollment
36
Registered
2019-07-08
Start date
2019-08-30
Completion date
2020-02-24
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

One-quarter of adolescents live with regular, debilitating kneecap pain. This causes substantial pain and disability, and reduces quality of life. Kneecap pain in adolescents is not a self-limiting condition – up to 95% continue to have pain after two to eight years. This can set the scene for a lifetime of knee pain and associated health implications, with many adolescents reducing or withdrawing from sport and physical activity. The problem is the lack of evidence and clinical guidelines for effective treatments for adolescents with kneecap pain. Best-evidence treatments for adults with kneecap pain, such as exercise, are not as effective for adolescents. This may be because adolescents simply do not do their prescribed exercises. 'Off-the-shelf' shoe inserts may be the solution. These are simple, accessible, low-cost devices that are easy for adolescents to wear in their regular footwear, such as school and sports shoes. The HAPPi Kneecaps! Trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating shoe inserts for adolescents with kneecap pain. Secondary outcomes will explore whether shoe inserts can improve pain, function and quality of life in this population. Findings will inform future large-scale clinical trials, with the potential to advise clinical practice guidelines providing adolescents with effective, evidence-based options for managing their kneecap pain. This study is an essential first step in identifying effective interventions for adolescents with kneecap pain, with the potential to change the persistent, chronic nature of kneecap pain at its earliest onset.

Interventions

Contoured inserts: Participants will receive commercially available prefabricated foot orthoses (Vasyli Medical, Labrador, Australia). These are manufactured from ethylene-vinyl acetate (EVA) of high, medium and low density, and have an inbuilt arch support and varus wedging. A variety of lengths and shapes will be utilised to fit the shape of each participant’s footwear appropriately. Each participant will attend a private physiotherapy clinic for fitting of the inserts. Study practitioners

Contoured inserts: Participants will receive commercially available prefabricated foot orthoses (Vasyli Medical, Labrador, Australia). These are manufactured from ethylene-vinyl acetate (EVA) of high, medium and low density, and have an inbuilt arch support and varus wedging. A variety of lengths and shapes will be utilised to fit the shape of each participant’s footwear appropriately. Each participant will attend a private physiotherapy clinic for fitting of the inserts. Study practitioners will be trained in fitting procedures, and will follow our published algorithm (Collins NJ et al, 2019, BMJ Open, 9(4):e025315). Practitioners will ensure that the inserts are comfortable, and can enhance this by adding wedges or gently heat molding the device. Participants will receive up to four pairs of inserts fit to their daily shoes (e.g. school shoes, sports shoes, casual shoes), which can be transferred to other footwear as required. Participants will attend up to three appointments with the physiotherapist to ensure adequate comfort of the inserts, and will receive written instructions for using and adapting to the inserts. Participants will be asked to wear their inserts as much as possible during their waking hours, and record their daily hours of wear in a logbook. Study practitioners will record the number of appointments attended.

Sponsors

Dr Natalie Collins
Lead SponsorIndividual

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 18 Years
Healthy volunteers
No

Inclusion criteria

(i) Aged 12-18 years; (ii) anterior knee pain of non-traumatic origin that is rated at least 3 on an 11-point numerical rating scale (0=no pain, 10=maximal pain); (iii) knee pain aggravated by activities that load the patellofemoral joint (e.g. squatting, stair climbing); (iv) knee pain present at some time during most weeks; and (v) knee pain of at least 2 months duration.

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) recent treatment for PFP (knee injections or physiotherapy within the previous 3 months; foot orthoses within the previous 12 months); and (v) any foot condition precluding the use of foot orthoses.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026