Extracorporeal Shockwave Therapy (ESWT) for the Management of Stress Fractures and High-grade Bone Stress Injuries (BSIs)
NCT06609265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2026-08-13
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.
Conditions
- Bones Stress Injury
- Bone Stress Fracture
Interventions
- DEVICE
-
Extracorporeal shockwave treatment (ESWT).
Extracorporeal shockwave treatment is a therapeutic modality that uses focused shockwaves through an electrohydraulic process that uses higher energy per unit area.
- DEVICE
-
Sham Device
The sham device (placebo) will be used in correlation with the standard of care procedures.
Sponsors & Collaborators
-
U.S. Army Medical Research and Development Command
collaborator FED -
United States Department of Defense
collaborator FED -
University of California, Los Angeles
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2027-05-01
- Completion
- 2027-11-01
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07216625 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06422065 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02662049 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01773265 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06262906 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00780065 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00630526 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06626451 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02325609 ·Status: WITHHELD
-
Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees
NCT06620861 ·Status: TERMINATED ·Phase: NA
-
Research Study for Patients With Neurological Diseases Which Evaluates the Patient Experience of the MemorEM Device
NCT07222605 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06362564 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05092256 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06422962 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02561052 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06629519 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02966210 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05226975 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05263258 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02634125 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01747265 ·Status: WITHHELD
-
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
NCT07112365 ·Status: RECRUITING ·Phase: PHASE4
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03182660 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06658028 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06171256 ·Status: WITHHELD