Photobiomodulation for Temporomandibular Disorder Pain (ULLTRA Trial)

N/A

Recruiting

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; about 6 months

Summary

This trial aims to test if light therapy can help relieve pain from TMD, a gum and jaw disorder. Double-blind, sham-controlled, randomized study used.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While PBM is FDA-approved for temporary muscle and joint pain relief, potential side effects specific to this treatment in the context of TMD have not been detailed but may include discomfort or changes in sensation at the application site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; about 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; about 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; about 6 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

Pain Level Change with PBM treatment using a Numerical Rating Scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: Active PBMExperimental Treatment1 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 PBMPlacebo Group1 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.

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