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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called photobiomodulation (PBMT) to determine if it accelerates healing of stress fractures in the leg or foot for individuals in military training. Participants will receive standard care and be randomly assigned to either real or sham (inactive) PBMT. Researchers aim to assess how quickly participants can return to duty and how their pain and function improve. Ideal candidates for this trial are those in military training with a confirmed stress fracture in the tibia or metatarsal, who have not received certain recent treatments or have specific medical conditions.

As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to innovative treatments for stress fractures.

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 prior data suggests that photobiomodulation therapy is safe for treating stress fractures?

Research has shown that photobiomodulation therapy (PBMT) is generally safe for people. This treatment uses light to reduce pain and swelling and to support healing. Studies have found that PBMT is noninvasive, meaning it doesn't involve surgery, and it doesn't produce heat, making it gentle on the body.

A large review of over 9,000 patients linked PBMT to positive outcomes for various health issues. The therapy has been used in different situations to aid bone repair, showing benefits such as promoting blood vessel growth and helping fractures heal.

Overall, PBMT is well-tolerated, with few reports of side effects. This suggests it is a safe option for those considering participation in a study involving this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Photobiomodulation Therapy is unique because it uses light to stimulate healing in stress fractures, unlike traditional treatments that typically involve rest and physical therapy. This therapy harnesses specific wavelengths of light to penetrate tissues and encourage cellular repair, potentially speeding up recovery. Researchers are excited about its non-invasive nature and the possibility of reducing recovery times, which could be a game-changer for athletes and active individuals looking to return to their routines more quickly.

What evidence suggests that photobiomodulation therapy is effective for stress fractures?

Research has shown that photobiomodulation therapy (PBMT) can aid bone healing. Studies have found that it supports bone growth and accelerates recovery. PBMT uses light to promote tissue healing, which is particularly beneficial for bone injuries. Some research also suggests that PBMT can improve blood flow and facilitate the formation of new bone cells. Although more research is needed, early studies are promising for using PBMT to treat stress fractures. In this trial, participants will receive either PBMT or sham PBMT, both alongside standard physical therapy, to evaluate its effectiveness in treating stress fractures. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel Rhon, DSc, PhD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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 (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 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]

Citations

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0020138319305492

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mdpi.com

mdpi.com/1422-0067/24/8/7094

The Role of Low-Level Laser Therapy in Bone Healing

In vivo and in vitro studies have shown that low-level laser therapy (LLLT) promotes angiogenesis, fracture healing and osteogenic differentiation of stem ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0377123706801486

Low Level Laser Therapy in Treatment of Stress Fractures ...

LLLT appears beneficial in treatment of stress fracture in this preliminary study. A larger multicentric study is indicated to prove the benefit conclusively.

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Photobiomodulation therapy - JADA Foundational Science

This nonthermal, noninvasive, and nonsurgical light treatment has been reported to reduce pain or inflammation, modulate immune responses, and promote tissue ...

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Effects of photobiomodulation on multiple health outcomes

Fifteen meta-analyses of RCTs covered over 9000 patients with 35 unique health endpoints and 15 unique health outcomes, including burning mouth ...