Trial Outcomes & Findings for Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting (NCT NCT05843864)
NCT ID: NCT05843864
Last Updated: 2026-07-15
Results Overview
Graduation on time is a measure of successful return to duty
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
4 months
Results posted on
2026-07-15
Participant Flow
Participant milestones
| Measure |
Photobiomodulation Therapy
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Photobiomodulation Therapy
n=48 Participants
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=49 Participants
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.0 years
STANDARD_DEVIATION 4.5 • n=48 Participants
|
23.4 years
STANDARD_DEVIATION 3.9 • n=49 Participants
|
23.7 years
STANDARD_DEVIATION 4.2 • n=97 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=48 Participants
|
26 Participants
n=49 Participants
|
51 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=48 Participants
|
23 Participants
n=49 Participants
|
46 Participants
n=97 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Service Branch
Army
|
39 Participants
n=48 Participants
|
39 Participants
n=49 Participants
|
78 Participants
n=97 Participants
|
|
Service Branch
Navy
|
6 Participants
n=48 Participants
|
6 Participants
n=49 Participants
|
12 Participants
n=97 Participants
|
|
Service Branch
Air Force
|
3 Participants
n=48 Participants
|
4 Participants
n=49 Participants
|
7 Participants
n=97 Participants
|
PRIMARY outcome
Timeframe: 4 monthsGraduation on time is a measure of successful return to duty
Outcome measures
| Measure |
Photobiomodulation Therapy
n=48 Participants
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=49 Participants
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
Graduated on Time
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 4 monthsThe DVPRS captures pain intereference and provided on a numeric rating scale of 0 (no pain interference) to 10 (interferences the most).
Outcome measures
| Measure |
Photobiomodulation Therapy
n=48 Participants
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=49 Participants
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
Defense and Veteran's Pain Rating Scale (DVPRS)
|
1.40 score on a scale
Interval 0.71 to 2.09
|
0.66 score on a scale
Interval -0.05 to 1.37
|
SECONDARY outcome
Timeframe: 4 MonthsThe LEFS is a self-reported assessment of physical function on a scale from 0 to 80, with higher scores indicating greater function.
Outcome measures
| Measure |
Photobiomodulation Therapy
n=48 Participants
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=49 Participants
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
Lower Extremity Functional Scale (LEFS)
|
69.47 Score on a scale
Interval 64.09 to 74.86
|
75.42 Score on a scale
Interval 68.4 to 82.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthsPopulation: The number of participants is fewer because this outcome represents only those who returned for a follow-up MRI withing 4 months.
Evidence of healing on MRI based on improved Fredericson Score
Outcome measures
| Measure |
Photobiomodulation Therapy
n=34 Participants
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=40 Participants
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
Evidence of Healing on MRI
|
24 Participants
|
31 Participants
|
Adverse Events
Photobiomodulation Therapy
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Photobiomodulation Therapy
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Photobiomodulation Therapy
n=48 participants at risk
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=49 participants at risk
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
General disorders
Emergency Department Visit
|
8.3%
4/48 • from enrollment through the 4 month follow-up.
|
2.0%
1/49 • from enrollment through the 4 month follow-up.
|
|
General disorders
Hospitalization
|
0.00%
0/48 • from enrollment through the 4 month follow-up.
|
4.1%
2/49 • from enrollment through the 4 month follow-up.
|
Other adverse events
| Measure |
Photobiomodulation Therapy
n=48 participants at risk
Photobiomodulation Therapy (PBMT) was provided using Omnilux PlusTM 830 nm panels. Treatment consisted of up to 3 sessions per week for up to 6 weeks (a total possible 18 sessions)
|
Sham Photobiomodulation Therapy
n=49 participants at risk
Patients received the same treatment, but with the photobiomodulation device left on standby, so no light therapy was emitted.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
2.1%
1/48 • from enrollment through the 4 month follow-up.
|
0.00%
0/49 • from enrollment through the 4 month follow-up.
|
|
General disorders
Pain in other body region (not leg)
|
0.00%
0/48 • from enrollment through the 4 month follow-up.
|
4.1%
2/49 • from enrollment through the 4 month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place