Trials Sponsors Conditions Drugs Pricing

Conditions

Metatarsal Stress Fracture Stress Fracture of Tibia

Keywords

Lower Extremity Bone Stress InjuriesPhotobiomodulationMilitary PopulationsPhotomedicineBone Stress Injuries

Outcome Measures

Primary Outcomes (1)

Graduated on Time
Graduation on time is a measure of successful return to duty
4 months

Secondary Outcomes (2)

Defense and Veteran's Pain Rating Scale (DVPRS)
4 months
Lower Extremity Functional Scale (LEFS)
4 Months

Other Outcomes (1)

Evidence of Healing on MRI
4 months

Study Arms (2)

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.

Device: Photobiomodulation Therapy with Standard Physical Therapy

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.

Other: Sham Photobiomodulation Therapy with Standard Physical Therapy

Interventions

Photobiomodulation Therapy with Standard Physical TherapyDevice

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.

Also known as: Omnilux Plus 830

Standard Physical Therapy and Photobiomodulation Therapy

Sham Photobiomodulation Therapy with Standard Physical TherapyOther

Eligibility Criteria

Age17 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

The Geneva Foundation
Othercollaborator
Brooke Army Medical Center
US federal agencylead
Uniformed Services University of the Health Sciences

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Related Publications (8)

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.
PMID: 26464890BACKGROUND
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.
PMID: 27753569BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Results Point of Contact

Title: Dan Rhon
Organization: Brooke Army Medical Center

Study Officials

Daniel Rhon, DSc, PhD
Uniformed Services University of the Health Sciences
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

103 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: FED
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Musculoskeletal Research in Primary Care Program

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 6, 2023

Study Start

June 7, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

Standard Physical Therapy and Photobiomodulation Therapy

Standard Physical Therapy and Sham Photobiomodulation Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

Standard Physical Therapy and Photobiomodulation Therapy

Standard Physical Therapy and Sham Photobiomodulation Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations