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.
Male or female 18 - 50 years of age who engage in greater than or equal to 2.5 hours a week of physical activity (in any sport, with the primary aim to maintain health and fitness), at screening.
Documentation of pelvic or lower extremity BSI diagnosis as evidenced by one or more clinical features consistent with the high-grade BSI by MRI grading (stress reactions of MRI grade 3 or stress fracture, grade 4 by Fredericson MRI Grading) with specific stress injury sites to be included: pelvis (including pubic ramus and sacrum), compression-sided femoral neck with fracture line less than 50% diameter if grade 4, femoral shaft, posteromedial tibia, calcaneus, metatarsal (2nd-4th, excluding proximal 2nd), and fibula.
Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
If on NSAIDs, willing to refrain from use during the study.
Pregnant, breastfeeding, plans to become pregnant during the study, or unwilling to practice birth control during participation in the study.
Unsuitable candidate for the study, based on the opinion of the investigator (e.g. cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study.
Subjects who, at entry, are known to have alternative treatment (e.g. surgery) planned within the next 8 weeks.
History of severe osteoporosis (prior DXA scan with Z-score of -3.0 or T-score less than or equal to -2.5 and prior fracture history) or other underlying bone disease/disorder.
University of California, Los Angeles
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborator
United States Department of Defense
Collaborator