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Fotobiomodulation til behandling af temporomandibulær lidelsessmerter (ULLTRA)

3. november 2026 opdateret af: University of Florida

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Eric Weber, CCRP
  • Telefonnummer: 352-273-7802
  • E-mail: ebweber@ufl.edu

Undersøgelse Kontakt Backup

  • Navn: Selenia Rubio, MD
  • Telefonnummer: 352-273-5590
  • E-mail: srubio7@ufl.edu

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • Rekruttering
        • University of Florida
        • Kontakt:
        • Ledende efterforsker:
          • Margarete Ribeiro-Dasilva, DDS, MS, Ph.D
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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 Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental: Active PBM

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.
Enhed: THOR® laser system

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.
Sham-komparator: Sham PBM

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.
Enhed: THOR® laser system

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Level Change with PBM treatment using a Numerical Rating Scale
Tidsramme: 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.
Through study completion; about 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Samarbejdspartnere

National Institute of Dental and Craniofacial Research (NIDCR)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. februar 2024

Primær færdiggørelse (Anslået)

1. oktober 2028

Studieafslutning (Anslået)

1. oktober 2028

Datoer for studieregistrering

Først indsendt

14. juni 2023

Først indsendt, der opfyldte QC-kriterier

14. juni 2023

Først opslået (Faktiske)

23. juni 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB202300986
  • UG3DE030433-01A1 (U.S. NIH-bevilling/kontrakt)
  • UH3DE030433 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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