Photobiomodulation for the management of Temporomandibular disorder pain
Photobiomodulation for the management of Temporomandibular disorder pain
批准号:
10518594
负责人:
Roger B Fillingim
金额:
$55.94万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-07-01 至 2023-07-31
关键词:
AdultAdvertisementsAffectAftercareAgeAnalgesicsAnti-Inflammatory AgentsArthralgiaBiologicalBloodBlood flowChronicChronic disabling painClinicalClinical TrialsCommunitiesComplexComputer AssistedDevelopmentDoseDose-RateDouble-Blind MethodDrug PrescriptionsEffectivenessEvidence based treatmentFaceGoalsHealth Care CostsHeterogeneityHospitalizationInflammationInflammatoryInflammatory ResponseInformed ConsentInjection of therapeutic agentInjectionsInternetJawLasersLeadLymphatic functionMechanicsMediatingMedical HistoryMeta-AnalysisMethodologyModalityMorbidity - disease rateMusculoskeletal DiseasesMusculoskeletal PainMyalgiaNatural regenerationNeural PathwaysNociceptionOperative Surgical ProceduresOpioidOrthodonticPainPain ThresholdPain intensityPain interferencePain managementParticipantPathway interactionsPatientsPeripheralPersonsPhototherapyPlacebosPopulationPre-Clinical ModelProtocols documentationQuality of lifeRandomizedRandomized Clinical TrialsRecording of previous eventsReportingResearch DesignScheduleSiteSpinal CordSteroidsSystemTMD treatmentTelephoneTemporomandibular Joint DisordersTemporomandibular joint disorder painTestingTherapeuticTherapeutic EffectTraumaTreatment EfficacyTreatment outcomeTrigeminal SystemVisitVisualanalogbasechronic painful conditionclinical examinationclinical paincommon treatmentcomparison groupcraniofacialcytokinediagnostic criteriaeffective therapyefficacy evaluationeligible participantexperiencefollow-upimprovedinjuredinterestmultimodalityorofacialpain sensitivitypatient populationphotobiomodulationpressureprimary outcomerecruitresponsescreeningsecondary outcomeside effectsymptomatologytreatment effecttreatment responsetrial designtrigger point
中文摘要
项目总结/文摘
英文摘要
Project Summary/Abstract
Given the paucity of effective treatments for TMD and the overuse of pain medication, well-designed studies are
needed to evaluate non-pharmacological alternatives to treat this common and disabling chronic pain condition.
Our goal in this study is to conduct a double-blind, sham-controlled, randomized clinical trial of multimodal
Photobiomodulation (PBM) for TMD pain. Also, we propose to determine if PBM-induced changes in
inflammation and pain sensitivity contribute to PBM’s analgesic effects. A total of 130 TMD participants will be
recruited through community-based advertisements. Participants will complete a computer-assisted telephone
screening (CATI). Eligible participants will be age 18 and older with pain intensity of ≥30 on a visual analog scale
(0-100). Participants will be excluded if: a) starting a new daily prescription medication for the management of
pain within 30 days before CATI; b) use of injection therapy (e.g., tender or trigger point injections, steroid
injections) for the management of pain within 2 weeks before the CATI; c) starting occlusal appliance therapy
within 30 days before CATI; d) history of facial trauma or orofacial surgery within 6 weeks before CATI; e) active
orthodontic treatment; f), psychiatric hospitalization within one year before the screening. Participants eligible
after CATI will be scheduled for a pre-randomization visit (V0), eight treatment visits (V1 to V8), one post-
treatment visit (V9), an internet/ phone follow-up at 1 and 3 months, and six-month follow-up clinical visit (V10).
V0 will include informed consent, completion of a detailed medical history and to assess clinical pain and
interference, participants will complete the Pain, Enjoyment, General Activity (PEG) Scale followed by a clinical
exam to confirm TMD status according to the Diagnostic Criteria for TMD (DC/TMD), Pressure Pain Sensitivity
(PPT) and blood draw. V1 will be the randomization visit to either receive PBM or Placebo. V2-V8 are treatment
visits. V5 is also the Midway visit, therefore, a blood draw, DC/TMD exam and PPT will be performed before
treatment. At V9 (post-treatment visit), post-treatment outcomes will be assessed, PEG, DC/TMD exam, PPT
and a blood draw. PBM/Placebo treatment: We will use three types of active/Placebo probes; A) Single Laser
808 nm, 4.75W/cm 2; B) Laser Cluster, five x 810 nm, 5.96W/cm 2 and four LED 660nm, 0.05W/cm 2and; C) LED
Cluster, 56 X 660nm 0.51W/cm2 and 48 850nm, 0.45W/cm2, 950mW total applied to multiple craniofacial sites.
Analyses will determine treatment effects on the primary outcome (pain intensity) and multiple secondary
outcomes and will examine, exploratorily, whether changes in inflammation and pain sensitivity mediate
treatment response. Findings from this rigorously designed trial will provide the most definitive evidence to date
regarding the effectiveness and mechanisms of PBM for treating TMD pain.
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Photobiomodulation for the management of Temporomandibular disorder pain
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批准号:10830073
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项目类别:
-
资助金额:$71.39万
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财政年份:2022
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负责人:Roger B Fillingim
-
依托单位:
Administrative Core
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批准号:10249075
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项目类别:
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资助金额:$18.16万
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财政年份:2018
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负责人:Roger B Fillingim
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依托单位:
University of Florida Resource Center for Minority Aging Research
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批准号:10658996
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项目类别:
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资助金额:$13.64万
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财政年份:2018
-
负责人:Roger B Fillingim
-
依托单位:
University of Florida Resource Center for Minority Aging Research
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批准号:10249074
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项目类别:
-
资助金额:$35.44万
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财政年份:2018
-
负责人:Roger B Fillingim
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依托单位:
University of Florida Resource Center for Minority Aging Research
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批准号:10390949
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项目类别:
-
资助金额:$12.5万
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财政年份:2018
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负责人:Roger B Fillingim
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依托单位:
Research Education Component
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批准号:10451662
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项目类别:
-
资助金额:$5.62万
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财政年份:2018
-
负责人:Roger B Fillingim
-
依托单位:
University of Florida Resource Center for Minority Aging Research
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批准号:10451660
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项目类别:
-
资助金额:$35.38万
-
财政年份:2018
-
负责人:Roger B Fillingim
-
依托单位:
University of Florida Resource Center for Minority Aging Research
-
批准号:9789140
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项目类别:
-
资助金额:$33.56万
-
财政年份:2018
-
负责人:Roger B Fillingim
-
依托单位:
Administrative Core
-
批准号:10451661
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项目类别:
-
资助金额:$18.52万
-
财政年份:2018
-
负责人:Roger B Fillingim
-
依托单位:
Research Education Component
-
批准号:10249076
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项目类别:
-
资助金额:$5.62万
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财政年份:2018
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负责人:Roger B Fillingim
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依托单位:
the Integrative and Multidisciplinary Pain and Aging Research Training (IMPART) Program
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批准号:10468098
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项目类别:
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资助金额:$49.47万
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财政年份:2015
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负责人:Roger B Fillingim
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依托单位:
the Integrative and Multidisciplinary Pain and Aging Research Training (IMPART) Program
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批准号:10672357
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项目类别:
-
资助金额:$49.36万
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财政年份:2015
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负责人:Roger B Fillingim
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依托单位:
the Integrative and Multidisciplinary Pain and Aging Research Training (IMPART) Program
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批准号:10352321
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项目类别:
-
资助金额:$7.57万
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财政年份:2015
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负责人:Roger B Fillingim
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依托单位:
Integrative and Multidisciplinary Pain and Aging Research Training
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批准号:9143042
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项目类别:
-
资助金额:$26.03万
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财政年份:2015
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负责人:Roger B Fillingim
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依托单位:
Integrative and Multidisciplinary Pain and Aging Research Training
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批准号:9305825
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项目类别:
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资助金额:$26.58万
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财政年份:2015
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负责人:Roger B Fillingim
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依托单位:
Integrative and Multidisciplinary Pain and Aging Research Training
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批准号:9750577
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项目类别:
-
资助金额:$7.96万
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财政年份:2015
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负责人:Roger B Fillingim
-
依托单位:
the Integrative and Multidisciplinary Pain and Aging Research Training (IMPART) Program
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批准号:10222508
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项目类别:
-
资助金额:$45.61万
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财政年份:2015
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负责人:Roger B Fillingim
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依托单位:
Pain and Aging Research Translational Initiative
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批准号:8764254
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项目类别:
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资助金额:$13.5万
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财政年份:2014
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负责人:Roger B Fillingim
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依托单位:
Pain and Aging Research Translational Initiative
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批准号:8915601
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项目类别:
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资助金额:$13.4万
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财政年份:2014
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负责人:Roger B Fillingim
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依托单位:
Ethnic Differences in Responses to Painful Stimuli
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批准号:7812862
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项目类别:
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资助金额:$71.27万
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财政年份:2009
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负责人:Roger B Fillingim
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依托单位:
海外基金