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COMPLETED

NCT05843864

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

Sponsor: Brooke Army Medical Center

View on ClinicalTrials.gov

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).

Official title: Utilizing Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting

Key Details

Gender

All

Age Range

17 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2023-06-07

Completion Date

2025-08-14

Last Updated

2026-07-15

Healthy Volunteers

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.

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)

Locations (1)

Brooke Army Medical Center

San Antonio, Texas, United States