Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting (PM12)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Metatarsal Stress Fracture; Stress Fracture of Tibia
• Intervention / Treatment: Device: Photobiomodulation Therapy with Standard Physical Therapy; Other: Sham Photobiomodulation Therapy with Standard Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline Wilkins; Phone Number: 210-808-2575; Email: madeline.x.wilkins.ctr@health.mil

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78219
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Tina Greenlee, PhD; Phone Number: 210-808-2575; Email: tina.a.greenlee.ctr@health.mil
      • Principal Investigator: Nathan A Parsons, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Physical Therapy and Photobiomodulation Therapy; 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; 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.; Other Names: Omnilux Plus 830
Sham Comparator: Standard Physical Therapy and Sham Photobiomodulation Therapy; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fredericson grading system	Severity of the stress fracture is assessed from Magnetic Resonance Imaging by a radiologist. Severity is classified as Grade "1", "2", "3", "4a" or "4b", with "Grade 1" being the least severe.	Baseline
Fredericson grading system	Severity of the stress fracture is assessed from Magnetic Resonance Imaging by a radiologist. Severity is classified as Grade "1", "2", "3", "4a" or "4b", with "Grade 1" being the least severe.	6 week
Fredericson grading system	Severity of the stress fracture is assessed from Magnetic Resonance Imaging by a radiologist. Severity is classified as Grade "1", "2", "3", "4a" or "4b", with "Grade 1" being the least severe.	4 months

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Collaborators: Uniformed Services University of the Health Sciences; The Geneva Foundation
• Investigators: Principal Investigator: Daniel Rhon, DSc, PhD, Uniformed Services University of the Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Photobiomodulation; Photomedicine; Lower Extremity Bone Stress Injuries; Military Populations; Bone Stress Injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Fractures, Stress
• Other Study ID Numbers: C.2023.025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes