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

Trial Summary

What is the purpose of this trial?

Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

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 data supports the effectiveness of this treatment for temporomandibular disorder pain?

Research shows that low-level laser therapy (LLLT) can be effective in reducing pain and improving function in people with temporomandibular disorders (TMD). Studies have found that LLLT helps manage pain and improve the movement of the jaw in TMD patients. ^{1 2 3 4 5}

Is photobiomodulation therapy safe for humans?

Low-level laser therapy (LLLT), also known as photobiomodulation therapy, is generally considered safe for humans. It is a noninvasive and quick treatment that has been used for various conditions, including temporomandibular joint disorders, without significant safety concerns. ^{1 2 4 5 6}

How does the THOR® laser system treatment differ from other treatments for temporomandibular disorder pain?

The THOR® laser system, also known as low-level laser therapy (LLLT), is unique because it uses light to reduce pain and inflammation without heat, unlike other treatments that may involve medication or physical therapy. This non-invasive approach targets the affected area directly, potentially offering relief without the side effects associated with drugs. ^{1 3 4 5 7}

Eligibility Criteria

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 have an active rheumatic disease.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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) 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]

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]

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]

References

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

Effectiveness of low-level laser therapy in temporomandibular joint disorders: a placebo-controlled study. [2015]

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

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

3. India pubmed.ncbi.nlm.nih.gov

Efficacy of low-level laser therapy in temporomandibular disorders: A systematic review. [2020]

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

Effectiveness of low-level laser therapy in temporomandibular disorders: a systematic review and meta-analysis. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy evaluation of low-level laser therapy on temporomandibular disorder]. [2018]

6. Spain pubmed.ncbi.nlm.nih.gov

The use of low level laser therapy in the treatment of temporomandibular joint disorders. Review of the literature. [2021]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparative evaluation of low-level laser therapy and ultrasound heat therapy in reducing temporomandibular joint disorder pain. [2022]