Recruiting

Extracorporeal Shockwave Therapy

Sponsor:

UCLA

Code:

NCT06609265

Conditions

Bones Stress Injury

Bone Stress Fracture

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Extracorporeal shockwave treatment (ESWT).

Sham Device

Study Details

Brief 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

Study ID

NCT06609265

Start date

May 1, 2025

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • If female of child-bearing potential, both of the following must be met at screening:
  • Practices one of the following methods of contraception and continues through the duration of the study: abstinence, hormonal contraceptives, IUD, spermicide and barrier or implantable device, and
  • Has a negative urine qualitative beta-HCG pregnancy test.
  • If female and post-menopausal one of the following must be met at screening:
  • Has had a complete hysterectomy, bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy, or
  • Is postmenopausal for at least one year.

Exclusion Criteria:

  • 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.
  • Chronic rheumatologic condition and/or history of chronic oral steroid use.
  • Type II diabetes, other chronic underlying disease.
  • Morbid obesity (Body Mass Index greater than or equal to 35) at screening.
  • Has clinically significant renal disease defined as having an estimated creatinine clearance of greater than or equal to 40mL/min at screening.
  • History of osteomyelitis in the injured area on which the treatment is to be administered at screening.
  • Has a current history of substance abuse (current is defined as within 120 days of screening).
  • Has evidence of a prior fracture or BSI within the last 6 months in the same area as the current injury.
  • Has active cellulitis or wound either at the injury site, or in the surrounding area at screening.
  • Has an injury requiring surgical intervention at screening.
  • Current/active DSM-V eating disorder diagnosis.
  • History of vascular insufficiency.
  • History of neurologic insufficiency.
  • History of coagulopathy, including previous deep vein thrombosis within six months of Visit 1; and/or therapy with anticoagulation medication (e.g. warfarin).
  • Radiation treatment within 120 days of Visit 1.
  • Presence of malignant disease with or without metastases.
  • Has a life expectancy of less than or equal to 2 years.
  • History of sickle cell anemia.
  • Has a known immunodeficiency disorder to include, but not be limited to: AIDS, HIV, etc.
  • Has participated in another investigation within 30 days of Visit 1.
  • Has previously received extracorporeal shockwave therapy (ESWT) with a SANUWAVE device.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard of Care + ESWT

Participants in this arm will be receiving Extracorporeal shockwave treatment, supplementing their standard of care.

placebo comparator: Standard of Care + Sham Device

Participants in this arm will be receiving the sham device mimicking extracorporeal shockwave treatment, supplementing their standard of care.

Interventions

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.

Sham Device

The sham device (placebo) will be used in correlation with the standard of care procedures.

Primary outcome measure

  • Primary Outcome [ Time Frame: From baseline to the end of treatment at up to 8 months ]

Central Contacts and Locations

Central contacts

Perion L Smith

310-592-0008PerionSmith@mednet.ucla.edu

Bailey J Maslyar

310-210-6829bmaslyar@mednet.ucla.edu

Locations

UCLA Ronald Reagan Medical Center

Recruiting

Los Angeles, California, United States, 91803

Contacts

Debbie J Argueta Rufino

310-210-6829DArguetaRufino@mednet.ucla.edu

Azraa Adamjee

424-467-6746AAdamjee@mednet.ucla.edu

Principal Investigator:

Kristofer Jones, Medical Degree

Stanford University Arrillaga Center for Sports and Recreation

Recruiting

Stanford, California, United States, 94305

Contacts

Chantal Nguyen

415-672-8095nguyenc3@stanford.edu

Principal Investigator:

Michael Fredericson, MD

Harvard - Spaulding Rehabilitation Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Michael Cheung

617-573-6981MCHEUNG0@MEEI.HARVARD.EDU

Principal Investigator:

Adam Tenforde, Medical Degree

More Information

Sponsor

University of California, Los Angeles

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • ESWT/BSI
  • Shockwave
  • stress fractures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-08-13.