Pain Related to TMDULLTRANCT05916235
Photobiomodulation for Management of Temporomandibular Disorder Pain
A study testing THOR® laser system in people with Pain Related to TMD, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pain Related to TMD
- What is being tested?
- THOR® laser system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Selenia Rubio, MD, 352-273-5590, srubio7@ufl.edu
Eric Weber, CCRP, 352-273-7802, ebweber@ufl.edu
About this study
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.
- Conditions
- Pain Related to TMD
- Being tested
- THOR® laser system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR® laser systemDevice
We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. 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 superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active PBM | Experimental | 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. Receives: Device: THOR® laser system |
| Sham PBM | Sham comparator | 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. Receives: Device: THOR® laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Change with PBM treatment using a Numerical Rating Scale
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.
Measured: Through study completion; about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start8 Feb 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain Related to TMDStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916235
- Sponsor's protocol ID
- IRB202300986
- Other IDs
- UG3DE030433-01A1, UH3DE030433
- Acronym
- ULLTRA
- Status last verified
- Nov 2026
- First submitted
- 14 Jun 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rodriguez MG, Warchol M, Rubio S, Cabrera P, Reever R, Hosney S, Migliorati CA, Gibson Iii FC, Ohrbach R, Fillingim RB, Wallet S, Ribeiro Dasilva MC. In vitro effects of dual wavelength photobiomodulation on monocytic response in painful temporomandibular disorder. J Oral Facial Pain Headache. 2025 Dec;39(4):252-257. doi: 10.22514/jofph.2025.082. Epub 2025 Dec 12.
PubMed 41436122Rubio S, Cabrera P, Reever R, Migliorati C, Ohrbach R, Gibson FC 3rd, Li Z, Mickle A, Conic RRZ, Fillingim RB, Ribeiro Dasilva M. A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults. Contemp Clin Trials Commun. 2025 Nov 24;48:101571. doi: 10.1016/j.conctc.2025.101571. eCollection 2025 Dec.
PubMed 41399628
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for Management of Temporomandibular Disorder Pain
- ClinicalTrials.gov ID
- NCT05916235
- Acronym / sponsor ID
- ULLTRA / IRB202300986
- Conditions
- Pain Related to TMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Active PBM | Experimental | Device: THOR® laser systemPBM 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. |
| Sham PBM | Sham comparator | Device: THOR® laser systemWhen 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR® laser systemWe chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. 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 superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation. | Device | Experimental: Active PBM, Sham PBM |
Primary outcome
Pain Level Change with PBM treatment using a Numerical Rating Scale
Time frame: Through 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 41436122Rodriguez MG, Warchol M, Rubio S, Cabrera P, Reever R, Hosney S, Migliorati CA, Gibson Iii FC, Ohrbach R, Fillingim RB, Wallet S, Ribeiro Dasilva MC. In vitro effects of dual wavelength photobiomodulation on monocytic response in painful temporomandibular disorder. J Oral Facial Pain Headache. 2025 Dec;39(4):252-257. doi: 10.22514/jofph.2025.082. Epub 2025 Dec 12.
- Derived from this study: PubMed 41399628Rubio S, Cabrera P, Reever R, Migliorati C, Ohrbach R, Gibson FC 3rd, Li Z, Mickle A, Conic RRZ, Fillingim RB, Ribeiro Dasilva M. A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults. Contemp Clin Trials Commun. 2025 Nov 24;48:101571. doi: 10.1016/j.conctc.2025.101571. eCollection 2025 Dec.
- Individual participant dataSharing planned: Undecided
Related trials for Pain Related to TMD
Active, not recruitingPhase 4
Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders
TMD, TMD/Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THOR® laser system in people with Pain Related to TMD, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selenia Rubio, MD (352-273-5590, srubio7@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level Change with PBM treatment using a Numerical Rating Scale (time frame: Through study completion; about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.