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

Primary Purpose

Metatarsal Stress Fracture, Stress Fracture of Tibia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photobiomodulation Therapy with Standard Physical Therapy
Sham Photobiomodulation Therapy with Standard Physical Therapy
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metatarsal Stress Fracture focused on measuring Lower Extremity Bone Stress Injuries, Photobiomodulation, Military Populations, Photomedicine, Bone Stress Injuries

Eligibility Criteria

17 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brooke Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Standard Physical Therapy and Photobiomodulation Therapy

Standard Physical Therapy and Sham Photobiomodulation Therapy

Arm Description

61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.

61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.

Outcomes

Primary Outcome Measures

Time to Return to Duty
After treatment for stress fracture begins, the number of days before they return to duty will be counted.

Secondary Outcome Measures

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.
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").
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").
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").
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").
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".
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"
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"
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"
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).
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).
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).
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).

Full Information

First Posted
April 18, 2023
Last Updated
June 12, 2023
Sponsor
Brooke Army Medical Center
Collaborators
The Geneva Foundation, Uniformed Services University of the Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05843864
Brief Title
Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
Acronym
PM12
Official Title
Utilizing Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center
Collaborators
The Geneva Foundation, Uniformed Services University of the Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsal Stress Fracture, Stress Fracture of Tibia
Keywords
Lower Extremity Bone Stress Injuries, Photobiomodulation, Military Populations, Photomedicine, Bone Stress Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Physical Therapy and Photobiomodulation Therapy
Arm Type
Experimental
Arm Description
61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
Arm Title
Standard Physical Therapy and Sham Photobiomodulation Therapy
Arm Type
Sham Comparator
Arm Description
61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation Therapy with Standard Physical Therapy
Other Intervention Name(s)
Omnilux Plus 830
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Photobiomodulation Therapy with Standard Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Return to Duty
Description
After treatment for stress fracture begins, the number of days before they return to duty will be counted.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions
Description
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
Title
Percussion Test
Description
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
Title
Percussion Test
Description
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
Title
Percussion Test
Description
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
Title
Percussion Test
Description
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
Title
Hopping Test
Description
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
Title
Hopping Test
Description
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
Title
Hopping Test
Description
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
Title
Hopping Test
Description
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
Title
Lower Extremity Functional Scale (LEFS)
Description
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
Title
Lower Extremity Functional Scale (LEFS)
Description
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
Title
Lower Extremity Functional Scale (LEFS)
Description
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
Title
Lower Extremity Functional Scale (LEFS)
Description
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
Other Pre-specified Outcome Measures:
Title
Fredericson grading system
Description
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.
Time Frame
Baseline
Title
Fredericson grading system
Description
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.
Time Frame
6 week
Title
Fredericson grading system
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeline Wilkins
Phone
210-808-2575
Email
madeline.x.wilkins.ctr@health.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rhon, DSc, PhD
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Greenlee, PhD
Phone
210-808-2575
Email
tina.a.greenlee.ctr@health.mil
First Name & Middle Initial & Last Name & Degree
Nathan A Parsons, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26464890
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.
Results Reference
background
PubMed Identifier
27753569
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.
Results Reference
background
PubMed Identifier
17937356
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.
Results Reference
background
PubMed Identifier
32175566
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.
Results Reference
background
PubMed Identifier
33975344
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.
Results Reference
background
PubMed Identifier
21539165
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.
Results Reference
background
PubMed Identifier
21793616
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.
Results Reference
background

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

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