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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
| Uniformed Services University of the Health Sciences | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Physical Therapy and Photobiomodulation Therapy | Experimental | 61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. |
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| Standard Physical Therapy and Sham Photobiomodulation Therapy | Sham Comparator | 61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation Therapy with Standard Physical Therapy | Device | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rhon, DSc, PhD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26464890 | Background | 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. | |
| 27753569 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2023 | Apr 22, 2024 |
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| Sham Photobiomodulation Therapy with Standard Physical Therapy | Other | 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. |
|
| 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 |
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 |
| 17937356 | Background | 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. |
| 32175566 | Background | 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. |
| 33975344 | Background | Kardouni JR, McKinnon CJ, Taylor KM, Hughes JM. Timing of Stress Fractures in Soldiers During the First 6 Career Months: A Retrospective Cohort Study. J Athl Train. 2021 Dec;56(12):1278-1284. doi: 10.4085/1062-6050-0380.19. Epub 2021 May 11. |
| 21539165 | Background | 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. |
| 21793616 | Background | 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. |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2026 | Jun 23, 2026 | 8 |
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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