Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting (PM12)
Metatarsal Stress Fracture, Stress Fracture of Tibia
About this trial
This is an interventional treatment trial for Metatarsal Stress Fracture focused on measuring Lower Extremity Bone Stress Injuries, Photobiomodulation, Military Populations, Photomedicine, Bone Stress Injuries
Eligibility Criteria
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)
Sites / Locations
- Brooke Army Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Standard Physical Therapy and Photobiomodulation Therapy
Standard Physical Therapy and Sham Photobiomodulation Therapy
61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.