Extracorporeal Shockwave Therapy (ESWT) for the Management of Stress Fractures and High-grade Bone Stress Injuries (BSIs)

Inclusion Criteria: * Male or female 18 - 50 years of age who engage in greater than or equal to 2.5 hours a week of physical activity (in any sport, with the primary aim to maintain health and fitness), at screening. * Documentation of pelvic or lower extremity BSI diagnosis as evidenced by one or more clinical features consistent with the high-grade BSI by MRI grading (stress reactions of MRI grade 3 or stress fracture, grade 4 by Fredericson MRI Grading) with specific stress injury sites to be included: pelvis (including pubic ramus and sacrum), compression-sided femoral neck with fracture line less than 50% diameter if grade 4, femoral shaft, posteromedial tibia, calcaneus, metatarsal (2nd-4th, excluding proximal 2nd), and fibula. * Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. * If on NSAIDs, willing to refrain from use during the study. * If female of child-bearing potential, both of the following must be met at screening: * Practices one of the following methods of contraception and continues through the duration of the study: abstinence, hormonal contraceptives, IUD, spermicide and barrier or implantable device, and * Has a negative urine qualitative beta-HCG pregnancy test. * If female and post-menopausal one of the following must be met at screening: * Has had a complete hysterectomy, bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of…