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

September 9, 2026 updated by: Aurelia Nattiv, University of California, Los Angeles

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Extracorporeal shockwave treatment (ESWT) administered using the SANUWAVE Profile ESWT device is an established therapeutic modality that uses focused shockwaves through an electrohydraulic process that uses higher energy per unit area.

Each subject will receive treatment: the goal for each participant is to receive a total of 4 treatment sessions, with the frequency of treatment being one treatment on average every 5 days (permitted frequency every 3-10 days).

The treatment and care of bone stress injuries will depend on the injury site identified for the subject as noted in Table 1 of the protocol. The initial treatment will be set at lower energy settings and will increase using standard language delivered to the patient for Treatment Sessions 2-4.

Subjects will be monitored for a period of up to 6 months for research follow-up. Standard of care follow-up period begins in which subjects will receive questionnaires and check-ins to monitor for adverse events until the subject is determined to be able to return to sport activity level. If subjects have serious questions, they will be advised to speak with their treating physician.

In total, subjects are to participate for a duration of 8 months. The total study duration for recruitment, enrollment, and study completion of all subjects will last up to 3 years.

UCLA will serve as the IRB of record for all sites, and all sites will conduct the study as described in this application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 91803
        • Recruiting
        • UCLA Ronald Reagan Medical Center
        • Contact:
        • Principal Investigator:
          • Kristofer Jones, Medical Degree
        • Principal Investigator:
          • Aurelia Nattiv, Medical Degree
        • Contact:
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford Physical Medicine and Rehabilitation in Redwood City
        • Principal Investigator:
          • Michael Fredericson, MD
        • Contact:
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Recruiting
        • Harvard - Spaulding Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Adam Tenforde, Medical Degree
    • New York
      • New York, New York, United States, 10021
        • Not yet recruiting
        • Hospital of Special Surgery (HSS) in NY
        • Contact:
        • Principal Investigator:
          • Marci Goolsby, Medical Degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard of Care + ESWT
Participants in this arm will be receiving Extracorporeal shockwave treatment, supplementing their standard of care.
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.
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.
Device: Sham Device
The sham device (placebo) will be used in correlation with the standard of care procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: From baseline to the end of treatment at up to 8 months
Incidence of adverse events as a measure of ESWT safety.
From baseline to the end of treatment at up to 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: From baseline to the end of treatment at up to 8 months

Radiographic healing of participants as defined by percentage of healing measured at different timepoints in the study. Radiographic healing at 8 weeks and 12 weeks compared to baseline will be defined as mild (0-30%), moderate (30-60%) or significant (greater than 60%) radiographic healing by MRI and mild (0-30%), moderate (30-60%) or significant (greater than 60%) radiographic healing as demonstrated by bone bridging by CT.

The investigators expect to see about 48% "healed" in the control group by 8 weeks. The investigators would compare the control group to the ESWT group. If ESWT speeds healing by 2 weeks in MRI grade 3 and 4 BSI, this would increase the percent healed to 69% in the treated group. If ESWT speeds healing by 3 weeks in MRI grade 3 and 4 BSI, this would increase the percent healed to 79%.
From baseline to the end of treatment at up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense
U.S. Army Medical Research and Development Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESWT4
  • MTEC2306-USAMRDCMultiTopic-094 (Other Grant/Funding Number: Department of Defense - MTEC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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