Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting (PM12)

July 13, 2026 updated by: Dan Rhon, Brooke Army Medical Center

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • 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 Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78219
        • Brooke Army Medical Center

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Physical Therapy and Photobiomodulation Therapy
61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
Device: Photobiomodulation Therapy with Standard Physical Therapy
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.
Other Names:
  • Omnilux Plus 830
Sham Comparator: Standard Physical Therapy and Sham Photobiomodulation Therapy
61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
Other: Sham Photobiomodulation Therapy with Standard Physical Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graduated on Time
Time Frame: 4 months
Graduation on time is a measure of successful return to duty
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defense and Veteran's Pain Rating Scale (DVPRS)
Time Frame: 4 months
The DVPRS captures pain intereference and provided on a numeric rating scale of 0 (no pain interference) to 10 (interferences the most).
4 months
Lower Extremity Functional Scale (LEFS)
Time Frame: 4 Months
The LEFS is a self-reported assessment of physical function on a scale from 0 to 80, with higher scores indicating greater function.
4 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of Healing on MRI
Time Frame: 4 months
Evidence of healing on MRI based on improved Fredericson Score
4 months

Collaborators and Investigators

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

Sponsor

Brooke Army Medical Center

Collaborators

Uniformed Services University of the Health Sciences
The Geneva Foundation

Investigators

  • Principal Investigator: Daniel Rhon, DSc, PhD, Uniformed Services University of the Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 7, 2023

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

August 14, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2023.025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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