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Photobiomodulation Therapy for Stress Fractures (PM12 Trial)

N/A
Recruiting
Led By Daniel Rhon, DSc, PhD
Research Sponsored by Brooke Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly up to 6 weeks, 4 months
Awards & highlights

Summary

This trial is testing a light therapy called PBMT to help military trainees with leg or foot stress fractures heal faster. The therapy aims to reduce pain and inflammation, helping cells repair more quickly. The goal is to see if this treatment helps trainees return to duty sooner. Photobiomodulation therapy (PBMT) combines low-level laser therapy (LLLT) and light emitting diode therapy (LEDT) to enhance cellular repair and reduce inflammation.

Who is the study for?
This trial is for military trainees aged 17-64 at Fort Sam Houston with a confirmed diagnosis of tibial or metatarsal stress injuries. They must understand English and commit to the study for up to 6 weeks, with follow-up through 4 months. Exclusions include recent dry needling, certain medical conditions like neuropathy, albinism, heart pacemakers, tattoos in treatment area, pregnancy plans during the study period, severe non-union fractures, light-induced allergies or eczema.
What is being tested?
The trial tests photobiomodulation therapy (PBMT) alongside standard physical therapy for bone stress injuries versus a sham PBMT with standard care. Participants are randomly assigned to either active or placebo treatments and evaluated on recovery speed and improvements in pain and function.
What are the potential side effects?
While specific side effects of PBMT aren't detailed here, common concerns may include skin irritation at the treatment site or discomfort during therapy sessions. The safety profile will be closely monitored given that participants have various exclusions related to sensitivity towards light-based therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly up to 6 weeks, 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly up to 6 weeks, 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Return to Duty
Secondary study objectives
Defense and Veteran's Pain Rating Scale (DVPRS) with supplemental questions
Hopping Test
Lower Extremity Functional Scale (LEFS)
+1 more
Other study objectives
Fredericson grading system

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard Physical Therapy and Photobiomodulation TherapyExperimental Treatment1 Intervention
61 Participants will be randomized to this group and will receive Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.
Group II: Standard Physical Therapy and Sham Photobiomodulation TherapyPlacebo Group1 Intervention
61 Participants will be randomized to this group and will receive sham Photobiomodulation Therapy (PBMT) in addition to standard physical therapy.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Photobiomodulation Therapy (PBMT) is a treatment that uses low-level lasers or LEDs to promote tissue repair and reduce inflammation in Metatarsal Stress Fracture patients. The light energy penetrates the skin and is absorbed by the cells, enhancing cellular function and promoting healing. This can reduce pain, decrease inflammation, and accelerate tissue repair, which is crucial for patients as it can potentially shorten recovery time and improve functional outcomes.
Effect of cortisone and an anabolic steroid upon plasma hydroxyproline during fracture healing in rabbits.Palovarotene inhibits connective tissue progenitor cell proliferation in a rat model of combat-related heterotopic ossification.[Extracorporeal shockwave therapy (ESWT) in orthopedic indications: a selective review].

Find a Location

Who is running the clinical trial?

Uniformed Services University of the Health SciencesFED
122 Previous Clinical Trials
90,422 Total Patients Enrolled
Brooke Army Medical CenterLead Sponsor
127 Previous Clinical Trials
26,658 Total Patients Enrolled
The Geneva FoundationOTHER
35 Previous Clinical Trials
12,939 Total Patients Enrolled

Media Library

Standard Physical Therapy and Photobiomodulation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05843864 — N/A
Metatarsal Stress Fracture Research Study Groups: Standard Physical Therapy and Sham Photobiomodulation Therapy, Standard Physical Therapy and Photobiomodulation Therapy
Metatarsal Stress Fracture Clinical Trial 2023: Standard Physical Therapy and Photobiomodulation Therapy Highlights & Side Effects. Trial Name: NCT05843864 — N/A
Standard Physical Therapy and Photobiomodulation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05843864 — N/A
~14 spots leftby Dec 2024
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