ALLSTAR Study
This is a double blinded randomised controlled trial looking at the effectiveness of low intensity pulsed ultrasound for the treatment of lower limb long bone stress fractures in an active sporting population.
Ethics
This study has ethics approval through the UNSW Human Research Ethics Advisory Panel.
Inclusion Criteria
Stress Fractures of the shafts of:
Tibia (excluding the anterior cortex)
Fibula
Metatarsals (2nd to 4th, excluding the 5th)
Subjects of all levels of sporting activity are welcome to enrol.
MRI Scans
All subjects are required to have MRI scans at the start and at the completion of their treatment. For the purposes of standardisation, all scans must be performed at Ultrascan Radiology, Westmead. For the initial scan, patients will be billed by Ultrascan for $150. If they are deemed eligible for the ALLSTAR study by the research team, they will be reimbursed the full amount.
Funding
This study has obtained a funding grant from the Australian Sports Commission.
Safety
As this intervention is not ingested and does not break the skin, there are minimal side effects. It is also painless and can be used at home. There is no radiation from the intervention.
Non-compliance
All funding is generously provided by the various organisations listed on this website, including funds from the Federal Government via the Australian Sports Commission. Failure to attend scheduled medical reviews or non-compliance with the treatment protocols will result in being subjected to the full undiscounted fee of the MRI scan ($250). To ensure this does not occur, study participants must inform the research team as soon as possible if for any reason they are not able to complete the study protocol. Leniency may be given on a case to case basis after review by the principal researcher.