A Randomized, Double-blind, Dose-escalation, Sham-controlled Trial to Evaluate the Safety and Feasibility of Extracorporeal Shockwave Therapy (ESWT) for the Management of Stress Fractures and High-grade Bone Stress Injuries (BSIs)
University of California, Los Angeles
Summary
The goal of this clinical trial is to evaluate the clinical safety and efficacy of Extracorporeal Shockwave Therapy (ESWT) for the management of high-grade Bone Stress Injuries (BSIs) in collegiate and recreational athletes compared to a control group receiving standard of care with sham ESWT. The primary and secondary endpoints of the study are to evaluate the safety and feasibility of extracorporeal shockwave therapy for the treatment of pelvic and lower limb extremity fracture or BSI. Researchers will compare the ESWT group to the sham ESWT group to see if ESWT results in better safety and efficacy outcomes for treating high-grade BSIs. Participants will: * Undergo a screening period to determine eligibility. * Receive up to 4 treatment sessions of ESWT, with the frequency of sessions being approximately every 5 days (within a range of every 3-10 days). * Be monitored for up to 6 months for research follow-up, with further questionnaires and check-ins during the standard of care follow-up period until they are able to return to sport activity level.
Description
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…