Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Tr… (NCT05843864) | Clinical Trial Compass
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 range17 Years – 64 Years
SexALL
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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 …