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Photobiomodulation for Temporomandibular Disorder Pain

This study is investigating if photobiomodulation (PBM) using the THOR® laser system can help reduce pain from temporomandibular disorder (TMD). PBM uses light to help with pain, and while it's approved for some muscle and joint pain, it's not yet approved specifically for TMD. You may be able to join if you are 18 or older, have experienced facial pain for at least 3 months, and your pain level is 30 or higher on a 0-100 scale. The main goal is to see how much your pain level changes with PBM treatment over about 6 months. The current status of this study is unclear.

Study design
This is a double-blind, sham-controlled, randomized study, meaning some participants will receive the active treatment and others a placebo, without knowing which one. It plans to enroll about 130 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain level will be measured through study completion, which is about 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05916235

Photobiomodulation for Management of Temporomandibular Disorder Pain

Recruiting
NAAges 18–99InterventionalTreatment
University of Florida
~130 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:THOR® laser system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Level Change with PBM treatment using a Numerical Rating Scale
Measured over Through study completion; about 6 months

Conditions

Pain Related to TMD

Explore related trials

Temporomandibular Joint Disorder

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Selenia Rubio, MD
[email protected]
352-273-5590
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female, aged 18 years and older
Meets the CATI pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)\].
Willing to provide signed and dated informed consent
Willing to to comply with all study procedures and to be available for the duration of the study
Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
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

Exclusion

Active rheumatologic disease
Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, or uncontrolled seizures) that precludes participation as determined by the investigator
Initiated occlusal appliance therapy within 30 days prior to CATI
Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
Is in active orthodontic treatment
Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
Has a history of psychiatric hospitalization within one year prior to CATI
Currently pregnant or lactating
Has a known hypersensitivity to laser therapy
Currently being treated with chemotherapy or radiation therapy
Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator

What this trial measures

  • Pain Level Change with PBM treatment using a Numerical Rating ScaleThrough study completion; about 6 months

    The primary outcome measure will be the average of daily pain ratings on the numerical rating scale (0 = no pain, 100 = worst pain imaginable) from the Daily Symptom Diary. Daily pain ratings averaged over one week prior to randomization will be treated as the baseline variable. The average daily pain for one week prior to Visit 9 will be treated as the primary endpoint. This outcome measure averaged across multiple days provides a stable measure of pain that is less subject to recall bias.