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

Extracorporeal shockwave treatment (ESWT) administered using the SANUWAVE Profile ESWT device is an established therapeutic modality that uses focused shockwaves through an electrohydraulic process that uses higher energy per unit area. Each subject will receive treatment: the goal for each participant is to receive a total of 4 treatment sessions, with the frequency of treatment being one treatment on average every 5 days (permitted frequency every 3-10 days). The treatment and care of bone stress injuries will depend on the injury site identified for the subject as noted in Table 1 of the protocol. The initial treatment will be set at lower energy settings and will increase using standard language delivered to the patient for Treatment Sessions 2-4. Subjects will be monitored for a period of up to 6 months for research follow-up. Standard of care follow-up period begins in which subjects will receive questionnaires and check-ins to monitor for adverse events until the subject is determined to be able to return to sport activity level. If subjects have serious questions, they will be advised to speak with their treating physician. In total, subjects are to participate for a duration of 8 months. The total study duration for recruitment, enrollment, and study completion of all subjects will last up to 3 years. UCLA will serve as the IRB of record for all sites, and all sites will conduct the study as described in this application.