Metatarsal Stress FracturePM12NCT05843864
Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
A study testing Photobiomodulation Therapy with Standard Physical Therapy in people with Metatarsal Stress Fracture and Stress Fracture of Tibia, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare photobiomodulation therapy (PBMT) in addition to standard of care in the treatment of tibial and metatarsal bone stress injuries in a military training setting. Read more about this study
- Who is it for?
- Ages 17 to 64 years
- Conditions the study is for
- Metatarsal Stress Fracture, Stress Fracture of Tibia
- What is being tested?
- Photobiomodulation Therapy with Standard Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 14 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between ages 17-64 (inclusive) years old
- Currently completing Advanced Individual Training (AIT) training at Fort Sam Houston and at least 6 weeks prior to graduation
- Clinical diagnosis of metatarsal or medial tibial bone stress injury/stress fracture (unilateral or bilateral) by a healthcare provider based on accepted diagnostic criteria, with diagnostic imaging confirmation
- Able to read and understand English language for consent purposes
- Able to commit to study intervention and follow-up
Who cannot join
- Stress fracture to tibia that is not medial (e.g., anterior) or any location other than 5th metatarsal or medial tibia
- Has already become a severe non-union bone stress injury/fracture
- Received dry needling within the past 4 weeks
- Received Platelet Rich Plasma (PRP) injection, corticosteroid injection, or prolotherapy within the past 3 months
- Diagnosis of neuropathy affecting sensation to pain
- Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling (all below the knee)
Show all 18Show fewer
- Current or previous diagnosis of eating disorder (e.g., bulimia nervosa, anorexia nervosa, disordered eating, or other eating disorder not specified)
- Diagnosis of porphyria (light induced allergy) or photosensitive eczema
- Diagnosis of autoimmune disease (e.g., Lupus)
- Albinism
- Current use of anti-inflammatory steroids due to increased risk of Bone Stress Injury (BSI) with the past two weeks
- Current use of medications associated with sensitivity to heat or light in the past five days (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
- Previous or current (within the past 2 years) use of Depo Provera
- Current use of pacemaker
- Tattoo in the area of treatment due to sensitivity to Photobiomodulation Therapy (PBMT)
- Concurrent participation in another research study receiving treatment for metatarsal or medial tibial bone stress injury/stress fracture
- Currently pregnant or plan to become pregnant during intervention period (safety of PBMT not established in pregnancy)
- Current diagnosis or symptoms of amenorrhea (≥ 6 months without a menstrual period) or oligomenorrhea (only 4-9 menstrual periods in a year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78219
About this study
Official title: Utilizing Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
The goal of this clinical trial is to compare photobiomodulation therapy (PBMT) in addition to standard of care in the treatment of tibial and metatarsal bone stress injuries in a military training setting.
Participants will all receive usual care and also be randomized to either active or sham photobiomodulation therapy. Effectiveness will be assessed based on time to return to duty and measures of pain and function.
- Participants will receive care for a maximum of 6 weeks.
- Participants will have follow-up through 4 months (or graduation/dismissal from training, whichever comes first).
Read the detailed description
Trainees with a diagnosis of medial tibial or metatarsal bone stress injuries/stress fracture will be recruited. Patients that consent and enroll will be randomized to receive standard of care physical therapy with (1) photobiomodulation therapy (PBMT) or (2) sham PBMT. Patients will receive treatment 3x per week for up to 6 weeks. The primary outcome will be the time to return to duty. Secondary outcomes will include additional time points (3-week, 6-week, 4-month) and Patient-Reported Outcomes Measurement Information System (PROMIS®) measures of pain and function, lower extremity imaging and various other measures outlined in the "Outcome Measure" section. Participants will be asked to report any mineral supplementation and to record daily activity in a log. Survival analysis will be used to evaluate return to duty between treatment arms with censoring beyond 4 months.
Longitudinal hierarchical/multilevel models with random effects will be used to evaluate differences between treatment arms for the relevant outcome measures. Sensitivity analyses will be conducted predicting change in measures at the final follow-up relative to baseline, and will use linear generalized additive models.
- Being tested
- Photobiomodulation Therapy with Standard Physical Therapy, Sham Photobiomodulation Therapy with Standard Physical Therapy
- Keywords
- Lower Extremity Bone Stress Injuries, Photobiomodulation, Military Populations, Photomedicine, Bone Stress Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation Therapy with Standard Physical TherapyDevice
Also called Omnilux Plus 830
Photobiomodulation Therapy (PBMT) will be provided by a trained individual in addition to standard physical therapy. Treatment will be delivered for approximately 10-16 minutes. Participants will then be instructed to rest for 5 minutes after the treatment.
Sham Photobiomodulation Therapy with Standard Physical TherapyOther
Sham Photobiomodulation Therapy (PBMT) will be provided by a trained to the some location and with the same contact time and frequency as the active intervention (PBMT) in addition to standard physical therapy. Participants will then be instructed to rest for 5 minutes after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physical Therapy and Photobiomodulation Therapy | Experimental | 61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. Receives: Device: Photobiomodulation Therapy with Standard Physical Therapy |
| Standard Physical Therapy and Sham Photobiomodulation Therapy | Sham comparator | 61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. Receives: Other: Sham Photobiomodulation Therapy with Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graduated on Time
Graduation on time is a measure of successful return to duty
Measured: 4 months
Secondary outcomes (2)
Defense and Veteran's Pain Rating Scale (DVPRS)
The DVPRS captures pain intereference and provided on a numeric rating scale of 0 (no pain interference) to 10 (interferences the most).
Measured: 4 months
Lower Extremity Functional Scale (LEFS)
The LEFS is a self-reported assessment of physical function on a scale from 0 to 80, with higher scores indicating greater function.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Jun 2023
- Primary completion25 Mar 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Metatarsal Stress FractureStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation, Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Daniel Rhon, DSc, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843864
- Sponsor's protocol ID
- C.2023.025
- Acronym
- PM12
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2023
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wood AM, Hales R, Keenan A, Moss A, Chapman M, Davey T, Nelstrop A. Incidence and Time to Return to Training for Stress Fractures during Military Basic Training. J Sports Med (Hindawi Publ Corp). 2014;2014:282980. doi: 10.1155/2014/282980. Epub 2014 Jan 21.
PubMed 26464890Waterman BR, Gun B, Bader JO, Orr JD, Belmont PJ Jr. Epidemiology of Lower Extremity Stress Fractures in the United States Military. Mil Med. 2016 Oct;181(10):1308-1313. doi: 10.7205/MILMED-D-15-00571.
PubMed 27753569Reis JP, Trone DW, Macera CA, Rauh MJ. Factors associated with discharge during marine corps basic training. Mil Med. 2007 Sep;172(9):936-41. doi: 10.7205/milmed.172.9.936.
PubMed 17937356Molloy JM, Pendergrass TL, Lee IE, Chervak MC, Hauret KG, Rhon DI. Musculoskeletal Injuries and United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. Mil Med. 2020 Sep 18;185(9-10):e1461-e1471. doi: 10.1093/milmed/usaa027.
PubMed 32175566Kardouni JR, McKinnon CJ, Taylor KM, Hughes JM. Timing of Stress Fractures in Soldiers During the First 6 Career Months: A Retrospective Cohort Study. J Athl Train. 2021 Dec;56(12):1278-1284. doi: 10.4085/1062-6050-0380.19. Epub 2021 May 11.
PubMed 33975344Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.
PubMed 21539165Lee D; Armed Forces Health Surveillance Center (AFHSC). Stress fractures, active component, U.S. Armed Forces, 2004-2010. MSMR. 2011 May;18(5):8-11. No abstract available.
PubMed 21793616Rhon DI, Parsons NA, Greenlee TA, Metzger E, Hole SR, Hager N. Photobiomodulation therapy versus sham for tibial and metatarsal bone stress injuries in military trainees: A randomized controlled trial. Bone. 2026 Oct 15:118135. doi: 10.1016/j.bone.2026.118135. Online ahead of print.
PubMed 42880535
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
- ClinicalTrials.gov ID
- NCT05843864
- Acronym / sponsor ID
- PM12 / C.2023.025
- Keywords
- Lower Extremity Bone Stress Injuries, Photobiomodulation, Military Populations, Photomedicine, Bone Stress Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- The Geneva Foundation, Uniformed Services University of the Health Sciences
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 15 Jul 2026
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 compare photobiomodulation therapy (PBMT) in addition to standard of care in the treatment of tibial and metatarsal bone stress injuries in a military training setting.
Participants will all receive usual care and also be randomized to either active or sham photobiomodulation therapy. Effectiveness will be assessed based on time to return to duty and measures of pain and function.
- Participants will receive care for a maximum of 6 weeks.
- Participants will have follow-up through 4 months (or graduation/dismissal from training, whichever comes first).
Detailed description
Trainees with a diagnosis of medial tibial or metatarsal bone stress injuries/stress fracture will be recruited. Patients that consent and enroll will be randomized to receive standard of care physical therapy with (1) photobiomodulation therapy (PBMT) or (2) sham PBMT. Patients will receive treatment 3x per week for up to 6 weeks. The primary outcome will be the time to return to duty. Secondary outcomes will include additional time points (3-week, 6-week, 4-month) and Patient-Reported Outcomes Measurement Information System (PROMIS®) measures of pain and function, lower extremity imaging and various other measures outlined in the "Outcome Measure" section. Participants will be asked to report any mineral supplementation and to record daily activity in a log. Survival analysis will be used to evaluate return to duty between treatment arms with censoring beyond 4 months.
Longitudinal hierarchical/multilevel models with random effects will be used to evaluate differences between treatment arms for the relevant outcome measures. Sensitivity analyses will be conducted predicting change in measures at the final follow-up relative to baseline, and will use linear generalized additive models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Physical Therapy and Photobiomodulation Therapy | Experimental | Device: Photobiomodulation Therapy with Standard Physical Therapy61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. |
| Standard Physical Therapy and Sham Photobiomodulation Therapy | Sham comparator | Other: Sham Photobiomodulation Therapy with Standard Physical Therapy61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. |
Who may qualify
- Ages
- 17 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- between ages 17-64 (inclusive) years old
- Currently completing Advanced Individual Training (AIT) training at Fort Sam Houston and at least 6 weeks prior to graduation
- Clinical diagnosis of metatarsal or medial tibial bone stress injury/stress fracture (unilateral or bilateral) by a healthcare provider based on accepted diagnostic criteria, with diagnostic imaging confirmation
- Able to read and understand English language for consent purposes
- Able to commit to study intervention and follow-up
Key exclusion criteria (18 listed)
- Stress fracture to tibia that is not medial (e.g., anterior) or any location other than 5th metatarsal or medial tibia
- Has already become a severe non-union bone stress injury/fracture
- Received dry needling within the past 4 weeks
- Received Platelet Rich Plasma (PRP) injection, corticosteroid injection, or prolotherapy within the past 3 months
- Diagnosis of neuropathy affecting sensation to pain
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 |
|---|---|---|
| Photobiomodulation Therapy with Standard Physical TherapyAlso: Omnilux Plus 830Photobiomodulation Therapy (PBMT) will be provided by a trained individual in addition to standard physical therapy. Treatment will be delivered for approximately 10-16 minutes. Participants will then be instructed to rest for 5 minutes after the treatment. | Device | Standard Physical Therapy and Photobiomodulation Therapy |
| Sham Photobiomodulation Therapy with Standard Physical TherapySham Photobiomodulation Therapy (PBMT) will be provided by a trained to the some location and with the same contact time and frequency as the active intervention (PBMT) in addition to standard physical therapy. Participants will then be instructed to rest for 5 minutes after the treatment. | Other | Standard Physical Therapy and Sham Photobiomodulation Therapy |
Primary outcome
Graduated on Time
Time frame: 4 months
Graduation on time is a measure of successful return to duty
2 secondary outcomes
Defense and Veteran's Pain Rating Scale (DVPRS)
Time frame: 4 months
Lower Extremity Functional Scale (LEFS)
Time frame: 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26464890Wood AM, Hales R, Keenan A, Moss A, Chapman M, Davey T, Nelstrop A. Incidence and Time to Return to Training for Stress Fractures during Military Basic Training. J Sports Med (Hindawi Publ Corp). 2014;2014:282980. doi: 10.1155/2014/282980. Epub 2014 Jan 21.
- Background: PubMed 27753569Waterman BR, Gun B, Bader JO, Orr JD, Belmont PJ Jr. Epidemiology of Lower Extremity Stress Fractures in the United States Military. Mil Med. 2016 Oct;181(10):1308-1313. doi: 10.7205/MILMED-D-15-00571.
- Background: PubMed 17937356Reis JP, Trone DW, Macera CA, Rauh MJ. Factors associated with discharge during marine corps basic training. Mil Med. 2007 Sep;172(9):936-41. doi: 10.7205/milmed.172.9.936.
- Background: PubMed 32175566Molloy JM, Pendergrass TL, Lee IE, Chervak MC, Hauret KG, Rhon DI. Musculoskeletal Injuries and United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. Mil Med. 2020 Sep 18;185(9-10):e1461-e1471. doi: 10.1093/milmed/usaa027.
- Background: PubMed 33975344Kardouni JR, McKinnon CJ, Taylor KM, Hughes JM. Timing of Stress Fractures in Soldiers During the First 6 Career Months: A Retrospective Cohort Study. J Athl Train. 2021 Dec;56(12):1278-1284. doi: 10.4085/1062-6050-0380.19. Epub 2021 May 11.
- Background: PubMed 21539165Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.
- Background: PubMed 21793616Lee D; Armed Forces Health Surveillance Center (AFHSC). Stress fractures, active component, U.S. Armed Forces, 2004-2010. MSMR. 2011 May;18(5):8-11. No abstract available.
- Derived from this study: PubMed 42880535Rhon DI, Parsons NA, Greenlee TA, Metzger E, Hole SR, Hager N. Photobiomodulation therapy versus sham for tibial and metatarsal bone stress injuries in military trainees: A randomized controlled trial. Bone. 2026 Oct 15:118135. doi: 10.1016/j.bone.2026.118135. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Metatarsal Stress Fracture
Recruiting
Treatment of Fifth Metatarsal Zone 3 Fractures
Fractures, Stress, Metatarsal Fracture
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. This study is not recruiting at the moment.
Daniel Rhon, DSc, PhD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy with Standard Physical Therapy in people with Metatarsal Stress Fracture and Stress Fracture of Tibia, run by Brooke Army Medical Center at 1 site 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 5 inclusion and 18 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graduated on Time (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843864, which also lists 8 linked publications.
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 15 Jul 2026.