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

Study Overview
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Brief Summary
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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).

Detailed Description
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Trainees with a diagnosis of medial tibial or metatarsal bone stress injuries/stress fracture will be recruited. Patients that consent and enroll will be randomized to receive standard of care physical therapy with (1) photobiomodulation therapy (PBMT) or (2) sham PBMT. Patients will receive treatment 3x per week for up to 6 weeks. The primary outcome will be the time to return to duty. Secondary outcomes will include additional time points (3-week, 6-week, 4-month) and Patient-Reported Outcomes Measurement Information System (PROMIS®) measures of pain and function, lower extremity imaging and various other measures outlined in the Outcome Measure section. Participants will be asked to report any mineral supplementation and to record daily activity in a log. Survival analysis will be used to evaluate return to duty between treatment arms with censoring beyond 4 months. Longitudinal hierarchical/multilevel models with random effects will be used to evaluate differences between treatment arms for the relevant outcome measures. Sensitivity analyses will be conducted predicting change in measures at the final follow-up relative to baseline, and will use linear generalized additive models.

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

Conditions
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Metatarsal Stress Fracture, Stress Fracture of Tibia

Intervention / Treatment
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* Device: Photobiomodulation Therapy with Standard Physical Therapy
* Other: Sham Photobiomodulation Therapy with Standard Physical Therapy


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Physical Therapy and Photobiomodulation Therapy<br>61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. | Device: Photobiomodulation Therapy with Standard Physical Therapy<br>* 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.<br>* Other names: Omnilux Plus 830;|
| Sham Comparator: Standard Physical Therapy and Sham Photobiomodulation Therapy<br>61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. | Other: Sham Photobiomodulation Therapy with Standard Physical Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Return to Duty | After treatment for stress fracture begins, the number of days before they return to duty will be counted. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions | Pain will be captured weekly with this single-item assessment that utilizes a numerical rating scale (0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter) enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels. | Weekly up to 6 weeks, 4 months | 
| Percussion Test | The tester uses 2-3 fingers to firmly tap up and down on the injury area 3-4 times. Immediately afterwards, the individual provides a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). | Baseline | 
| Percussion Test | The tester uses 2-3 fingers to firmly tap up and down on the injury area 3-4 times. Immediately afterwards, the individual provides a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). | 3 weeks | 
| Percussion Test | The tester uses 2-3 fingers to firmly tap up and down on the injury area 3-4 times. Immediately afterwards, the individual provides a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). | 6 weeks | 
| Percussion Test | The tester uses 2-3 fingers to firmly tap up and down on the injury area 3-4 times. Immediately afterwards, the individual provides a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). | 4 months | 
| Hopping Test | Participants will be asked to perform up to 10 hops as tolerated on their symptomatic leg(s). At the conclusion of the test, participants will be asked to provide a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). If they are unable to reach 10 hops due to pain that will be recorded as an incomplete. | Baseline | 
| Hopping Test | Participants will be asked to perform up to 10 hops as tolerated on their symptomatic leg(s). At the conclusion of the test, participants will be asked to provide a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). If they are unable to reach 10 hops due to pain that will be recorded as an incomplete | 3 weeks | 
| Hopping Test | Participants will be asked to perform up to 10 hops as tolerated on their symptomatic leg(s). At the conclusion of the test, participants will be asked to provide a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). If they are unable to reach 10 hops due to pain that will be recorded as an incomplete | 6 weeks | 
| Hopping Test | Participants will be asked to perform up to 10 hops as tolerated on their symptomatic leg(s). At the conclusion of the test, participants will be asked to provide a pain rating (Defense and Veterans Pain Rating Scale 0-10, with 0 being No Pain and 10 being As bad as it could be, nothing else matter). If they are unable to reach 10 hops due to pain that will be recorded as an incomplete | 4 months | 
| Lower Extremity Functional Scale (LEFS) | The LEFS is a self-reported assessment of physical function. It asks 20 questions with response options of Extreme difficulty or unable to perform activity (0), Quite a bit of difficulty (1), Moderate difficulty (2), A little bit of difficulty (3), No difficulty (4). | Baseline | 
| Lower Extremity Functional Scale (LEFS) | The LEFS is a self-reported assessment of physical function. It asks 20 questions with response options of Extreme difficulty or unable to perform activity (0), Quite a bit of difficulty (1), Moderate difficulty (2), A little bit of difficulty (3), No difficulty (4). | 3 weeks | 
| Lower Extremity Functional Scale (LEFS) | The LEFS is a self-reported assessment of physical function. It asks 20 questions with response options of Extreme difficulty or unable to perform activity (0), Quite a bit of difficulty (1), Moderate difficulty (2), A little bit of difficulty (3), No difficulty (4). | 6 weeks | 
| Lower Extremity Functional Scale (LEFS) | The LEFS is a self-reported assessment of physical function. It asks 20 questions with response options of Extreme difficulty or unable to perform activity (0), Quite a bit of difficulty (1), Moderate difficulty (2), A little bit of difficulty (3), No difficulty (4). | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photobiomodulation, Lower Extremity Bone Stress Injuries, Military Populations, Photomedicine, Bone Stress Injuries