Photobiomodulation for Management of Temporomandibular Disorder Pain

Обзор

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.

Вмешательства

• Устройство 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)

Первичные конечные точки

• Pain Level Change with PBM treatment using a Numerical Rating Scale [Срок оценки: Through study completion; about 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Публикации

• 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. PMID 41436122
• Rubio 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. PMID 41399628

Идентификаторы

NCT: NCT05916235 · IRB202300986 · UG3DE030433-01A1 · UH3DE030433

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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