CompletedNot Applicable

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

United States105 participantsStarted 2023-06-07

Plain-language 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).

Who can participate

Age range

17 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Return to Duty

Timeframe: 4 months

Trial details

NCT IDNCT05843864

SponsorBrooke Army Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-03-25

View on ClinicalTrials.gov More Metatarsal Stress Fracture trials