Clinical trial NCT05843864: Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
Official title: Utilizing Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metatarsal Stress Fracture
Stress Fracture of Tibia
Keywords: Lower Extremity Bone Stress Injuries
Photobiomodulation
Military Populations
Photomedicine
Bone Stress Injuries
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: The Geneva Foundation
name: Uniformed Services University of the Health Sciences
First posted: 2023-05-06
Enrollment: 122
Sex: ALL
Minimum age (years): 17
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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)

Primary outcomes:
measure: Time to Return to Duty
timeFrame: 4 months
Secondary outcomes:
measure: Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions
timeFrame: Weekly up to 6 weeks, 4 months
measure: Percussion Test
timeFrame: Baseline
measure: Percussion Test
timeFrame: 3 weeks
measure: Percussion Test
timeFrame: 6 weeks
measure: Percussion Test
timeFrame: 4 months
measure: Hopping Test
timeFrame: Baseline
measure: Hopping Test
timeFrame: 3 weeks
measure: Hopping Test
timeFrame: 6 weeks
measure: Hopping Test
timeFrame: 4 months
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Baseline
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 3 weeks
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 6 weeks
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 4 months
Other outcomes:
measure: Fredericson grading system
timeFrame: Baseline
measure: Fredericson grading system
timeFrame: 6 week
measure: Fredericson grading system
timeFrame: 4 months
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Daniel Rhon, DSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood AM, Hales R, Keenan A, Moss A, Chapman M, Davey T, Nelstrop A. Incidence and Time to Return to Training for Stress Fractures during Military Basic Training. J Sports Med (Hindawi Publ Corp). 2014;2014:282980. doi: 10.1155/2014/282980. Epub 2014 Jan 21.
citation: Waterman BR, Gun B, Bader JO, Orr JD, Belmont PJ Jr. Epidemiology of Lower Extremity Stress Fractures in the United States Military. Mil Med. 2016 Oct;181(10):1308-1313. doi: 10.7205/MILMED-D-15-00571.
citation: Reis JP, Trone DW, Macera CA, Rauh MJ. Factors associated with discharge during marine corps basic training. Mil Med. 2007 Sep;172(9):936-41. doi: 10.7205/milmed.172.9.936.
citation: Molloy JM, Pendergrass TL, Lee IE, Chervak MC, Hauret KG, Rhon DI. Musculoskeletal Injuries and United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. Mil Med. 2020 Sep 18;185(9-10):e1461-e1471. doi: 10.1093/milmed/usaa027.
citation: Kardouni JR, McKinnon CJ, Taylor KM, Hughes JM. Timing of stress fracture in soldiers during the first 6 career months: a retrospective cohort study. J Athl Train. 2021 May 11;56(12):1278-84. doi: 10.4085/1062-6050-0380.19. Online ahead of print.
citation: Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.
citation: Lee D; Armed Forces Health Surveillance Center (AFHSC). Stress fractures, active component, U.S. Armed Forces, 2004-2010. MSMR. 2011 May;18(5):8-11. No abstract available.