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dc.contributor.authorSeminowicz, D.A.
dc.contributor.authorBilska, K.
dc.contributor.authorChowdhury, N.S.
dc.contributor.authorSkippen, P.
dc.contributor.authorMillard, S.K.
dc.contributor.authorChiang, A.K.I.
dc.contributor.authorChen, S.
dc.contributor.authorFurman, A.J.
dc.contributor.authorSchabrun, S.M.
dc.date.accessioned2021-02-08T20:13:36Z
dc.date.available2021-02-08T20:13:36Z
dc.date.issued2020-07-27
dc.identifier.urihttp://hdl.handle.net/10713/14592
dc.description.abstractIntroduction:Temporomandibular disorder is a common musculoskeletal pain condition with development of chronic symptoms in 49% of patients. Although a number of biological factors have shown an association with chronic temporomandibular disorder in cross-sectional and case control studies, there are currently no biomarkers that can predict the development of chronic symptoms. The PREDICT study aims to undertake analytical validation of a novel peak alpha frequency (PAF) and corticomotor excitability (CME) biomarker signature using a human model of the transition to sustained myofascial temporomandibular pain (masseter intramuscular injection of nerve growth factor [NGF]). This article describes, a priori, the methods and analysis plan.Methods:This study uses a multisite longitudinal, experimental study to follow individuals for a period of 30 days as they progressively develop and experience complete resolution of NGF-induced muscle pain. One hundred fifty healthy participants will be recruited. Participants will complete twice daily electronic pain diaries from day 0 to day 30 and undergo assessment of pressure pain thresholds, and recording of PAF and CME on days 0, 2, and 5. Intramuscular injection of NGF will be given into the right masseter muscle on days 0 and 2. The primary outcome is pain sensitivity.Perspective:PREDICT is the first study to undertake analytical validation of a PAF and CME biomarker signature. The study will determine the sensitivity, specificity, and accuracy of the biomarker signature to predict an individual's sensitivity to pain.Registration details:ClinicalTrials.gov: NCT04241562 (prospective). Copyright 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.en_US
dc.description.sponsorshipThis project is funded by grant 1R61NS113269 to 01 from The National Institutes of Health to DAS, SMS, and SC.en_US
dc.description.urihttps://doi.org/10.1097/PR9.0000000000000833en_US
dc.language.isoen_USen_US
dc.publisherLippincott Williams and Wilkinsen_US
dc.relation.ispartofPain Reports
dc.subjectBiomarkersen_US
dc.subjectElectroencephalographyen_US
dc.subjectNerve growth factoren_US
dc.subjectOrofacial painen_US
dc.subjectSusceptibilityen_US
dc.subjectTranscranial magnetic stimulationen_US
dc.titleA novel cortical biomarker signature for predicting pain sensitivity: Protocol for the PREDICT longitudinal analytical validation studyen_US
dc.typeArticleen_US
dc.identifier.doi10.1097/PR9.0000000000000833


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