Radiological Healing
Time frame · 8, 10, 12, 14, 16, 20, 24 weeks
Time to complete radiological healing
Time from randomisation to assessed as 'Clinically Healed'.
Time frame · Twice weekly from date of radiologically healed stress fracture reported on MRI scan up to 24 weeks
Physical assessment to commence once the fracture is reported as healed on MR.
Time to 'Healing' as a composite assessment.
Time frame · Up to 24 weeks.
Healing as assessed by MRI and clinical assessment.
Time from randomisation to discharge from rehabilitation.
Time frame · Up to 24 weeks
Completion of rehab will be assessed using Army standard measures.
Pain symptoms on a visual analogue pain scale.
Time frame · Diary to be completed weekly and analysed as a change from baseline to 16 weeks (24 weeks in an unhealed fracture).
Score between 0 and 10 - with 0 being no pain and 10 being worst pain imaginable.
Difference in Quality of life
Time frame · 4 weekly from baseline to 16 weeks
Assessed by Short Form 36 Questionnaire. The higher score, the better the participants quality of life.
Adverse events
Time frame · Up to 28 weeks.
As reported in accordance with CTAE Version 4.03