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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
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.
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.
Brooke Army Medical Center
San Antonio, Texas, United States
Time to Return to Duty
After treatment for stress fracture begins, the number of days before they return to duty will be counted.
Time frame: 4 months
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.
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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".
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.