Extracorporeal Shockwave Therapy (ESWT) for the Management of Stress Fractures and High-grade Bone Stress Injuries (BSIs)
Public ClinicalTrials.gov record NCT06609265. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06609265
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2025
- Primary completion
- Apr 30, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Aug 12, 2026
2025 – 2027
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 91803 | Recruiting |
| Stanford University Arrillaga Center for Sports and Recreation | Stanford | California | 94305 | Recruiting |
| Harvard - Spaulding Rehabilitation Hospital | Cambridge | Massachusetts | 02138 | Recruiting |
| Hospital of Special Surgery (HSS) in NY | New York | New York | 10021 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06609265, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06609265 live on ClinicalTrials.gov.