Clinical Trial

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

Study acronym: ESWT/BSI
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 changes
critical Trial status changed: Withheld → Recruiting 2026-08-12
critical Phase changed: not specified -> not applicable 2026-08-12
critical Primary endpoint(s) modified 2026-08-12
notable Enrollment changed: None -> 140 2026-08-12
notable Sponsor changed: [Redacted] -> University of California, Los Angeles 2026-08-12
minor Trial arms changed: 0 -> 2 2026-08-12
notable Trial sites expanded: 0 -> 4 locations 2026-08-12
Trial Details
NCT Number NCT06609265
Lead Sponsor University of California, Los Angeles
Collaborators: U.S. Army Medical Research and Development Command, United States Department of Defense
Conditions Bones Stress Injury, Bone Stress Fracture
Enrollment 140 participants
Start Date 2025-05-01
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13