Bones Stress InjuryESWT/BSINCT06609265
Extracorporeal Shockwave Therapy (ESWT) for the Management of Stress Fractures and High-grade Bone Stress Injuries (BSIs)
A study testing Extracorporeal shockwave treatment (ESWT). in people with Bones Stress Injury and Bone Stress Fracture, run by University of California, Los Angeles at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bones Stress Injury, Bone Stress Fracture
- What is being tested?
- Extracorporeal shockwave treatment (ESWT).
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Harvard - Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138
Michael Cheung, 617-573-6981, MCHEUNG0@MEEI.HARVARD.EDU
Adam Tenforde, Medical Degree
- Recruiting
UCLA Ronald Reagan Medical Center
Los Angeles, California, 91803
Bailey Maslyar, 310-869-5653, BMaslyar@mednet.ucla.edu
Azraa Adamjee, 424-467-6746, AAdamjee@mednet.ucla.edu
- Not yet recruiting
Hospital of Special Surgery (HSS) in NY
New York, New York, 10021
Olivia Lynch, 646-714-6435, lyncho@hss.edu
Marci Goolsby, Medical Degree
- Recruiting
Stanford Physical Medicine and Rehabilitation in Redwood City
Redwood City, California, 94063
Mikkael Lamoca, 650-721-7613, mlamoca@stanford.edu
Michael Fredericson, MD
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Bones Stress Injury, Bone Stress Fracture
- Being tested
- Extracorporeal shockwave treatment (ESWT)., Sham Device
- Keywords
- ESWT/BSI, Shockwave, stress fractures
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave treatment (ESWT).Device
Extracorporeal shockwave treatment is a therapeutic modality that uses focused shockwaves through an electrohydraulic process that uses higher energy per unit area.
Sham DeviceDevice
The sham device (placebo) will be used in correlation with the standard of care procedures.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + ESWT | Experimental | Participants in this arm will be receiving Extracorporeal shockwave treatment, supplementing their standard of care. Receives: Device: Extracorporeal shockwave treatment (ESWT). |
| Standard of Care + Sham Device | Placebo comparator | Participants in this arm will be receiving the sham device mimicking extracorporeal shockwave treatment, supplementing their standard of care. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Incidence of adverse events as a measure of ESWT safety.
Measured: From baseline to the end of treatment at up to 8 months
Secondary outcomes (1)
Secondary Outcome
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%.
Measured: From baseline to the end of treatment at up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bones Stress InjuryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, United States Department of Defense
- Responsible party
- Principal investigator, Aurelia Nattiv, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609265
- Sponsor's protocol ID
- ESWT4
- Other IDs
- MTEC2306-USAMRDCMultiTopic-094
- Acronym
- ESWT/BSI
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06609265
- Acronym / sponsor ID
- ESWT/BSI / ESWT4
- Conditions
- Bones Stress Injury, Bone Stress Fracture
- Keywords
- ESWT/BSI, Shockwave, stress fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, United States Department of Defense
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + ESWT | Experimental | Device: Extracorporeal shockwave treatment (ESWT).Participants in this arm will be receiving Extracorporeal shockwave treatment, supplementing their standard of care. |
| Standard of Care + Sham Device | Placebo comparator | Device: Sham DeviceParticipants in this arm will be receiving the sham device mimicking extracorporeal shockwave treatment, supplementing their standard of care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Standard of Care + ESWT |
| Sham DeviceThe sham device (placebo) will be used in correlation with the standard of care procedures. | Device | Standard of Care + Sham Device |
Primary outcome
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.
1 secondary outcome
Secondary Outcome
Time frame: From baseline to the end of treatment at up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave treatment (ESWT). in people with Bones Stress Injury and Bone Stress Fracture, run by University of California, Los Angeles at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perion L Smith (310-592-0008, PerionSmith@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: From baseline to the end of treatment at up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.