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

NCT05843864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-09-23

No results posted yet for this study

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.

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).

Conditions

  • Metatarsal Stress Fracture
  • Stress Fracture of Tibia

Interventions

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

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.

Sponsors & Collaborators

  • The Geneva Foundation

    collaborator OTHER

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Daniel Rhon, DSc, PhD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2025-03-25
Completion
2025-08-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843864 on ClinicalTrials.gov