NCT04120662.
Methods | Randomised, single‐blind, control trial |
Participants |
Enrolment: 30 participants Inclusion criteria: male soccer players aged over 18 years with a diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings, fracture occurred during soccer practice Exclusion criteria: anyone under 18 years old, traumatic fracture, fracture occurred out of soccer practice, patients with metatarsal shaft, neck or head fracture, patients with contraindication to receive surgical treatment, patients with contraindication to receive shock wave treatment, patients that refuse the informed consent |
Interventions |
Intervention details: 3 weekly session, one per week, of focused shock waves, using an electro hydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses. Control details: intramedullary screw fixation |
Outcomes |
Follow‐up schedule: monthly until return to play up to a maximum of 6 months Primary outcome: evaluation of healing on X‐Ray, time to return to play Secondary outcome: pain assessment using VAS, American Orthopaedic Foot and Ankle Score, evaluation of Tegner activity scale |
Notes |