What side effects are associated with this type of intervention?

Photobiomodulation Therapy (PBMT) is generally considered safe with minimal side effects, which may include temporary redness or irritation at the site of application. Other common treatments for metatarsal stress fractures, such as rest and physical therapy, typically have few side effects but may include muscle stiffness or soreness as the body adjusts to reduced activity levels. In some cases, overuse of anti-inflammatory medications can lead to gastrointestinal issues or kidney problems. Overall, non-invasive treatments for metatarsal stress fractures are well-tolerated with a low risk of serious side effects.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of metatarsal stress fractures using Photobiomodulation Therapy (PBMT) or similar light therapy in the provided context. Generally, treatments for metatarsal stress fractures include rest, immobilization, and physical therapy. Emerging therapies like PBMT are being studied for their potential to enhance tissue repair and reduce inflammation, but specific FDA approvals for this application are not detailed in the context.

What other types of research exist?

Promising alternatives to PBMT for metatarsal stress fracture patients include: 1) Extracorporeal Shock Wave Therapy (ESWT), which has shown efficacy in treating chronic tendon and bone injuries by promoting tissue repair and reducing pain. 2) Platelet-Rich Plasma (PRP) injections, which have demonstrated benefits in tendon and muscle injuries by enhancing healing through growth factors. Both therapies have been supported by clinical trials and could be considered as novel treatment options in 2024.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly up to 6 weeks, 4 months

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.

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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].