Photobiomodulation for Temporomandibular Disorder Pain

(ULLTRA Trial)

Overseen By Selenia Rubio, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Rheumatologic disease, Uncontrolled diabetes, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called photobiomodulation (PBM) to determine its effectiveness in reducing pain from temporomandibular disorder (TMD), which affects the jaw muscles. The treatment uses the THOR® laser system to target pain areas. Participants will receive either the real PBM treatment or a sham (fake) treatment for comparison. Individuals with facial pain lasting at least three months and a consistent pain level may be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start any new pain medications within 30 days before the trial begins.

What prior data suggests that this photobiomodulation treatment is safe for temporomandibular disorder pain?

Research has shown that the THOR® laser system, used in photobiomodulation (PBM) light therapy, has treated various types of pain for over 30 years. The FDA has approved it for temporary relief of muscle and joint pain, though not specifically for jaw pain related to temporomandibular disorder (TMD). The system is generally safe and complies with European safety standards.

However, the Class 3B lasers in the THOR® system can harm the eyes, so never look directly at the laser beam. Aside from this precaution, no major safety concerns have been reported. The system is considered safe for its approved uses, and ongoing research continues to explore additional applications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation (PBM) for temporomandibular disorder (TMD) pain because it offers a unique, non-invasive approach compared to standard treatments like medication, physical therapy, or surgery. Unlike these traditional methods, PBM uses the THOR® laser system to target multiple pathophysiological mechanisms, potentially addressing the multifactorial nature of TMD pain more effectively. This advanced laser therapy aims to reduce pain by promoting tissue repair and reducing inflammation, offering a promising alternative for those who haven't found relief with existing treatments. Additionally, the THOR® system's innovative design ensures that even the sham treatments mimic the heating sensation, maintaining the integrity of research by helping to prevent bias in patient responses.

What evidence suggests that photobiomodulation might be an effective treatment for TMD pain?

Research has shown that photobiomodulation (PBM) can relieve pain from temporomandibular joint disorders (TMD), which affect the jaw. A detailed review of studies found that low-level laser therapy, a type of PBM, not only reduces pain but also improves jaw function in people with TMD. However, some studies suggest that PBM might not significantly outperform a placebo for long-term TMD pain. Despite these mixed results, PBM has been used for over 30 years to treat various types of pain. In this trial, participants will receive either the active PBM treatment using the THOR® laser system, designed to target various pain sources in TMD, or a sham PBM treatment. This offers hope for those seeking relief. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with facial pain from Temporomandibular Disorder (TMD) lasting at least 3 months, and a weekly average pain score of ≥30 out of 100. Participants must meet specific diagnostic criteria for TMD, agree to the study's procedures, and be available throughout the study.

Inclusion Criteria

I have had facial pain for at least 3 months with a pain intensity of 30 or more.

Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100

Willing to provide signed and dated informed consent

Exclusion Criteria

I started treatments like acupuncture or biofeedback within the last 30 days.

I do not have any health conditions like severe kidney failure or uncontrolled diabetes that would stop me from joining.

I have an active rheumatic disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham PBM treatment for TMD pain

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• THOR® laser system

Trial Overview The trial tests Photobiomodulation (PBM) using the THOR® laser system for TMD-related pain. It's a double-blind study where participants are randomly assigned to receive either PBM or a sham treatment without knowing which one they're getting.

How Is the Trial Designed?

Group I: Experimental: Active PBM Experimental Treatment 1 Intervention

PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.

Group II: Sham PBM Placebo Group 1 Intervention

When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.

THOR® laser system is already approved in United States, European Union for the following indications:

Approved in United States as THOR Laser System for:

• Temporary relief of muscle and joint pain
• Relaxation of muscles and relief from muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis
• Temporarily increase blood circulation

Approved in European Union as THOR Laser System for:

• Soft tissue injuries
• Joint conditions
• Back and neck pain

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

Low-level laser therapy (LLLT) at energy densities of 10 J/cm² and 15 J/cm² significantly reduced pain in patients with temporomandibular joint disorders (TMD) compared to a placebo treatment, indicating its efficacy.

The study involved 61 patients and showed that LLLT is particularly effective for chronic pain associated with TMD, although there were no significant differences in pain reduction between the two energy levels used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of low-level laser therapy in temporomandibular joint disorders: a placebo-controlled study. Fikácková, H., Dostálová, T., Navrátil, L., et al.[2015]

In a study of 42 patients with temporomandibular joint disorders, low-level laser therapy (LLLT) significantly reduced pain more effectively than ultrasound heat therapy, as indicated by lower visual analog scale scores (4.81 vs. 6.19).

LLLT also improved mouth opening more than ultrasound therapy, with mean measurements of 3.99 cm compared to 3.65 cm, suggesting it is a more effective treatment option for TMD-related pain without bony pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of low-level laser therapy and ultrasound heat therapy in reducing temporomandibular joint disorder pain. Khairnar, S., Bhate, K., S N, SK., et al.[2022]

Low level laser therapy (LLLT) is a noninvasive and safe treatment option for temporomandibular disorders (TMDs), showing analgesic and anti-inflammatory effects, but its clinical efficacy remains controversial due to limited and variable studies.

A review of 16 relevant articles found that the current scientific evidence level for LLLT in treating TMDs is classified as level B, indicating moderate support, but most studies had methodological limitations that warrant cautious interpretation of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of low level laser therapy in the treatment of temporomandibular joint disorders. Review of the literature. Herranz-Aparicio, J., Vázquez-Delgado, E., Arnabat-Domínguez, J., et al.[2021]

Low-level laser therapy (LLLT) significantly reduced temporomandibular joint (TMJ) pain more effectively than a control treatment, as shown by a faster decrease in visual analogue scale (VAS) scores in the laser group over a 6-day treatment period with follow-ups at 1 and 2 months.

LLLT also improved jaw function, with greater increases in painless maximum vertical opening and lateral excursions in the laser group compared to the control group, indicating its efficacy in enhancing TMJ mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy evaluation of low-level laser therapy on temporomandibular disorder]. Wang, X., Yang, Z., Zhang, W., et al.[2018]

A systematic review of six randomized clinical trials found that low-level laser therapy (LLLT) did not significantly reduce pain in patients with temporomandibular disorders (TMD) compared to placebo, indicating a lack of efficacy.

Secondary outcomes related to jaw movement improvements were also minimal, suggesting that LLLT is not an effective treatment option for TMD based on the current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of low-level laser therapy in temporomandibular disorders: a systematic review and meta-analysis. Petrucci, A., Sgolastra, F., Gatto, R., et al.[2022]

Low-level laser therapy (LLLT) has been found to be effective in reducing pain associated with temporomandibular disorders (TMDs), based on a systematic review of 13 randomized controlled trials.

Out of the studies analyzed, 7 showed significant improvement in pain and other symptoms, suggesting that LLLT could be a viable noninvasive treatment option for patients seeking complementary therapies for TMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low-level laser therapy in temporomandibular disorders: A systematic review. Shukla, D., Muthusekhar, MR.[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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05916235

Study Details | NCT05916235 | Photobiomodulation for ... We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8169142/

Low-level laser therapy in temporomandibular joint disorders A systematic review with meta-analyses demonstrated that LLLT is not only effective in pain relief but also improves functional outcomes in TMD patients [4].

3. thorlaser.com thorlaser.com/sports/research.php

Research Abstracts Low level laser therapy with the suggested dose range significantly reduces pain and improves health status in chronic joint disorders, but the heterogeneity in ...

4. files.jofph.com files.jofph.com/files/article/20231220-566/pdf/jop_25_4_Petrucci_3.pdf

Effectiveness of Low-Level Laser Therapy in ... This systematic review indicated that LLLT was not better than placebo in reducing chronic TMD pain, which is in agreement with the results reported in previous ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04415281

Study Details | NCT04415281 | Photobiomodulation for the ... We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and ...

6. thorlaser.com thorlaser.com/

THOR Laser: Photobiomodulation (PBM Therapy) Low ... The THOR LX2.3 Photobiomodulation system has a medical CE mark (EC certificate). It is indicated for oral mucositis, tendinopathies, joint pain, neck pain and ...

7. thorlaser.com thorlaser.com/safety/

Photobiomodulation (PBM Therapy) Safety - THOR Laser Class 3B lasers are potentially hazardous to the eye. Never stare into the beam or direct the beam into the eyes of others.

8. thorlaser.com thorlaser.com/regulations/

Low Level Laser LLLT Cold Laser Photobiomodulation ... The THOR LX2.3 Photobiomodulation system has a medical CE mark (EC certificate). It is indicated for oral mucositis, tendinopathies, joint pain, neck pain and ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05916235?spons=National%20institute%20of%20Dental%20and%20Craniofacial%20Research%20(NIDCR)&locStr=Florida,%20USA&country=United%20States&state=Florida&distance=50&term=dental&rank=6

Study Details | NCT05916235 | Photobiomodulation for ... Device : THOR® laser system. We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light.

10. aetna.com aetna.com/cpb/medical/data/300_399/0363.html

Cold Laser and High-Power Laser Therapies Aetna considers low-level laser therapy medically necessary for prevention of oral mucositis in persons undergoing cancer treatment associated with ...