Photobiomodulation Therapy for Stress Fractures

(PM12 Trial)

Overseen By Cristal Hernandez, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Must not be taking: Anti-inflammatory steroids, Heat/light sensitive drugs

Disqualifiers: Neuropathy, Sciatica, Eating disorders, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 6 weeks

122 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that increase sensitivity to heat or light within the past five days, and anti-inflammatory steroids within the past two weeks. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Photobiomodulation Therapy for stress fractures?

Research shows that low-level laser therapy (LLLT), a form of photobiomodulation, has been effective in reducing pain and inflammation and promoting healing in various conditions, including rheumatoid arthritis and chronic pain. These benefits suggest potential effectiveness for stress fractures as well. ^{1 2 3 4 5}

Is Photobiomodulation Therapy generally safe for humans?

Photobiomodulation Therapy, also known as Low-Level Laser Therapy, has been used in various medical fields like wound healing, pain management, and dentistry, showing positive effects without significant safety concerns. However, more well-designed studies are needed to establish standardized safety protocols. ^{2 3 6 7 8}

How does photobiomodulation therapy differ from other treatments for stress fractures?

Photobiomodulation therapy, also known as low-level laser therapy (LLLT), is unique because it uses light to stimulate healing and reduce inflammation without the need for drugs or surgery. Unlike standard treatments for stress fractures, which typically involve rest and physical therapy, LLLT directly targets cellular processes to promote faster recovery. ^{2 3 5 7 9}

Research Team

Daniel Rhon, DSc, PhD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

Able to commit to study intervention and follow-up

I have a diagnosed stress fracture in my foot or shin confirmed by imaging.

Currently completing Advanced Individual Training (AIT) training at Fort Sam Houston and at least 6 weeks prior to graduation

Exclusion Criteria

I have a stress fracture in my tibia that is not on the inner side.

My bone fracture has not healed and is considered severe.

I experience ongoing or frequent pain, numbness, or tingling in my leg below the knee.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard physical therapy with either active or sham photobiomodulation therapy 3 times per week

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including pain and function measures

4 months

Regular assessments up to 4 months

Treatment Details

Interventions

• Photobiomodulation Therapy
• Sham Photobiomodulation Therapy

Trial Overview 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.

Participant Groups

Group I: Standard Physical Therapy and Photobiomodulation Therapy Experimental Treatment 1 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 Therapy Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Findings from Research

Low-level light therapy (LLLT) shows promising benefits in periodontal and dental implant treatments, demonstrating biostimulatory, anti-inflammatory, and analgesic effects that can enhance healing and reduce inflammation.

Despite the positive findings, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based protocols for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Low-level laser therapy (LLLT) utilizes the unique properties of low-energy laser radiation to promote healing and reduce pain, making it a versatile treatment option in various medical fields such as regenerative medicine, dentistry, and physiotherapy.

LLLT is effective in applications like wound healing, scar improvement, and pain reduction, demonstrating its potential as a safe and non-invasive therapeutic method in both clinical practice and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Low-Level Energy Laser Radiation in Basic and Clinical Research. Rola, P., Doroszko, A., Derkacz, A.[2019]

Low-level light therapy (photobiomodulation) shows promising benefits in periodontal and dental implant treatments, including enhanced healing and reduced inflammation, based on a review of various studies.

Despite the positive effects observed, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based treatment protocols for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level laser therapy (LLLT) significantly reduced pain in patients with temporomandibular disorders (TMD), as evidenced by a decrease in pain scores from 27.5 to 4.16 on the Visual Analog Scale after five treatment sessions.

LLLT also improved the range of motion in the jaw, increasing the ability to open the mouth from 34 mm to 42 mm, indicating its efficacy in enhancing TMJ function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physiotherapy and GaAlAs laser in the management of temporomandibular joint disorders. Dostalová, T., Hlinakova, P., Kasparova, M., et al.[2021]

References

1. Iran pubmed.ncbi.nlm.nih.gov

Low-Level Laser Therapy for Rheumatoid Arthritis: A Review of Experimental Approaches. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A NASA discovery has current applications in orthopaedics. [2020]

5. India pubmed.ncbi.nlm.nih.gov

Low Level Laser Therapy in Treatment of Stress Fractures Tibia: A Prospective Randomized Trial. [2020]

6. China pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. [2015]

7. Poland pubmed.ncbi.nlm.nih.gov

The Use of Low-Level Energy Laser Radiation in Basic and Clinical Research. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of physiotherapy and GaAlAs laser in the management of temporomandibular joint disorders. [2021]