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

NCT05843864 | Completed FDA Device

• 1 other identifier: C.2023.025
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lower Extremity Bone Stress Injuries; Photobiomodulation; Military Populations; Photomedicine; Bone Stress Injuries

Outcome Measures

Primary Outcomes (1)

• Time to Return to Duty

  After treatment for stress fracture begins, the number of days before they return to duty will be counted.

  4 months

Secondary Outcomes (13)

• Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions

  Weekly up to 6 weeks, 4 months

• Percussion Test

  Baseline

• Percussion Test

  3 weeks

• Percussion Test

  6 weeks

• Percussion Test

  4 months

Other Outcomes (3)

• Fredericson grading system

  Baseline

• Fredericson grading system

  6 week

• Fredericson grading system

  4 months

Study Arms (2)

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.

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.

Other: Sham Photobiomodulation Therapy with Standard Physical Therapy

Interventions

Photobiomodulation Therapy with Standard Physical Therapy DEVICE

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.

Also known as: Omnilux Plus 830

Standard Physical Therapy and Photobiomodulation Therapy

Sham Photobiomodulation Therapy with Standard Physical Therapy OTHER

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.

Standard Physical Therapy and Sham Photobiomodulation Therapy

Eligibility Criteria

• Age: 17 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• The Geneva Foundation: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Related Publications (7)

• 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.

  PMID: 26464890 BACKGROUND

• Waterman 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.

  PMID: 27753569 BACKGROUND

• Reis 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.

  PMID: 17937356 BACKGROUND

• Molloy 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.

  PMID: 32175566 BACKGROUND

• Kardouni 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.

  PMID: 33975344 BACKGROUND

• Wentz 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.

  PMID: 21539165 BACKGROUND

• Lee 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.

  PMID: 21793616 BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Daniel Rhon, DSc, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Musculoskeletal Research in Primary Care Program

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 6, 2023
• Study Start: June 7, 2023
• Primary Completion: March 25, 2025
• Study Completion: August 14, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)