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

Not Applicable

Recruiting

• Conditions: Metatarsal Stress Fracture; Stress Fracture of Tibia

• Registration Number: NCT05843864
• Lead Sponsor: Brooke Army Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-4-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - between ages 17-64 (inclusive) years old<br><br> - Currently completing Advanced Individual Training (AIT) training at Fort Sam Houston<br> and at least 6 weeks prior to graduation<br><br> - Clinical diagnosis of metatarsal or medial tibial bone stress injury/stress fracture<br> (unilateral or bilateral) by a healthcare provider based on accepted diagnostic<br> criteria, with diagnostic imaging confirmation<br><br> - Able to read and understand English language for consent purposes<br><br> - Able to commit to study intervention and follow-up<br><br>Exclusion Criteria:<br><br> - Stress fracture to tibia that is not medial (e.g., anterior) or any location other<br> than 5th metatarsal or medial tibia<br><br> - Has already become a severe non-union bone stress injury/fracture<br><br> - Received dry needling within the past 4 weeks<br><br> - Received Platelet Rich Plasma (PRP) injection, corticosteroid injection, or<br> prolotherapy within the past 3 months<br><br> - Diagnosis of neuropathy affecting sensation to pain<br><br> - Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or<br> intermittent lower extremity pain, numbness, or tingling (all below the knee)<br><br> - Current or previous diagnosis of eating disorder (e.g., bulimia nervosa, anorexia<br> nervosa, disordered eating, or other eating disorder not specified)<br><br> - Diagnosis of porphyria (light induced allergy) or photosensitive eczema<br><br> - Diagnosis of autoimmune disease (e.g., Lupus)<br><br> - Albinism<br><br> - Current use of anti-inflammatory steroids due to increased risk of Bone Stress<br> Injury (BSI) with the past two weeks<br><br> - Current use of medications associated with sensitivity to heat or light in the past<br> five days (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide,<br> nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)<br><br> - Previous or current (within the past 2 years) use of Depo Provera<br><br> - Current use of pacemaker<br><br> - Tattoo in the area of treatment due to sensitivity to Photobiomodulation Therapy<br> (PBMT)<br><br> - Concurrent participation in another research study receiving treatment for<br> metatarsal or medial tibial bone stress injury/stress fracture<br><br> - Currently pregnant or plan to become pregnant during intervention period (safety of<br> PBMT not established in pregnancy)<br><br> - Current diagnosis or symptoms of amenorrhea (= 6 months without a menstrual period)<br> or oligomenorrhea (only 4-9 menstrual periods in a year)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Return to Duty

Secondary Outcome Measures

Name	Time	Method
Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions;Percussion Test;Percussion Test;Percussion Test;Percussion Test;Hopping Test;Hopping Test;Hopping Test;Hopping Test;Lower Extremity Functional Scale (LEFS);Lower Extremity Functional Scale (LEFS);Lower Extremity Functional Scale (LEFS);Lower Extremity Functional Scale (LEFS)