[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536016":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":72,"collaborators":28,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":28,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":28,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":28,"overallStatus":95,"whyStopped":28,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Universidade Federal de Sao Carlos","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Fractioned Pain Science Education + Manual Therapy + Orofacial and Neck Exercises","ACTIVE_COMPARATOR","All participants in this arm will initially receive six sessions in which a workshop on PSE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PSE program will be held in 6 sessions of 15 minutes each. Two protocols of Orofacial Exercises and Manual Therapy and of Neck Motor Control will be adopted in the present study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will consist of orofacial therapy and exercises and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.",[13,14,15],"Behavioral: Fractioned Pain Science Education (FPSE)","Other: Manual Therapy","Other: Orofacial and Neck Exercises (ONE)",{"label":17,"type":18,"description":19,"interventionNames":20},"Full Dosage Pain Science Education + Manual Therapy + Orofacial and Neck Exercises","EXPERIMENTAL","All participants in this arm will initially receive two sessions in which a workshop on PSE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PSE program will be held in 2 sessions of 45 minutes each one. Two protocols of Orofacial Exercises and Manual Therapy and of Neck Motor Control will be adopted in the present study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will consist of orofacial therapy and exercises and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.",[21,14,15],"Behavioral: Full Dosage Mode Pain Science Education (FDPSE)",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Fractioned Pain Science Education (FPSE)","Pain Science Education (PSE) will be administered in workshop sessions with interactive presentations, using different resources as metaphors and videos. It will be held in 2 sessions of 45 minutes each, covering 6 topics of Explain Pain and Explain Pain Supercharged books.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Full Dosage Mode Pain Science Education (FDPSE)","Pain Science Education (PSE) will be administered in workshop sessions with interactive presentations, using different resources as metaphors and videos. It will be held in 6 sessions of 15 minutes each, covering 6 topics of Explain Pain and Explain Pain Supercharged books.",[17],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Manual Therapy","Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.",[9,17],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Orofacial and Neck Exercises (ONE)","Orofacial Exercises: Mandibular body-condylar cross-pressure chewing technique; Post-isometric relaxation stretches-laterotrusion and opening (10 times\u002Fsession; 10 seconds).\n\nNeck Motor Control Exercises: Bracing exercises (6 hierarchical levels - HL). Extreme range of motion exercises (stable spine). Cervical isometric exercises (5 HL) directly forward, obliquely, toward right and left, and directly backward (stable spine - elastic resistive bands). Functional training with elastic resistance and exercise balls on unstable surfaces (8 HJ). The progress in each exercise domain will happen when sustaining the contraction for 10 seconds, 10 times.",[9,17],[42],{"name":43,"affiliation":44,"role":45},"Thais Chaves, Ph.D","Federal University of São Carlos - UFSCar","STUDY_CHAIR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Juliana Spavieri, MSc","CONTACT","05516 996092206","jspavieri@estudante.ufscar.br",{"name":53,"role":49,"phone":28,"phoneExt":28,"email":54},"Luiz Ricardo Garcês, MSc","luizgarcez07@hotmail.com",[56],{"facility":57,"status":28,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Federal University of São Carlos - Department of Physical Therapy","São Carlos","São Paulo","13565-905","Brazil","BR",{"type":64,"coordinates":65},"Point",[66,67],-47.89083,-22.0175,{"lat":67,"lon":66},[70],{"name":48,"role":49,"phone":71,"phoneExt":28,"email":51},"05516996092206",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Thais Chaves","Ph.D","100536016","pain-science-education-administered-in-full-or-fractioned-dosage-modes-for-temporomandibular-disorders-100536016",false,"NCT06259344","Pain Science Education Administered in Full or Fractioned Dosage Modes for Temporomandibular Disorders","Effect of Pain Science Education Administered in Full or Fractioned Dosage Modes Associated With Conventional Treatment on Pain Intensity and Disability for Temporomandibular Disorders: a Randomized Controlled Trial","Inclusion Criteria:\n\n* age between 20 and 60 years;\n* painful TMD (confirmed by applying DC\u002FTMD);\n* complaint of pain with a minimum intensity of 3 (on a scale of 0 to 10) present for at least 3 months;\n* fluency to speak and understand Brazilian Portuguese (Mini Cog instrument to assess cognitive capacity and the Cloze Test to certify textual reading comprehension)\n\nExclusion Criteria:\n\n* history of tumors in the orofacial region;\n* central and peripheral neurological diseases;\n* uncontrolled psychiatric illnesses;\n* pregnant women;\n* presence of toothache, neuralgia or chronic painful conditions in the head region, orofacial region or systemic pain (for example, fibromyalgia, osteoarthritis, osteoarthritis or rheumatological diseases);\n* report of previous major surgeries in the craniofacial region, such as orthognathic surgeries, TMJ surgeries, or resulting from post-trauma corrections;\n* history of major trauma involving the cervical or craniofacial region (facial trauma, whiplash injuries, etc.);\n* individuals undergoing physiotherapeutic treatment up to 6 months before the start of this study.","ALL","20 Years","60 Years",{"count":87,"type":88},148,"ESTIMATED","INTERVENTIONAL",[91],"NA","Temporomandibular Disorders (TMD) are a collection of musculoskeletal disorders which affect the masticatory structures and have a multifactorial etiology. A biopsychosocial approach is recommended for the management of these disorders including different interventions like exercise, manual therapy and pain education. The aim of this study is to compare the effect of a full dosage mode pain science education program (2 initial sessions of 45 minutes) versus a fractioned dosage format (6 sessions of 15 minutes) combined with manual therapy and orofacial exercises on primary outcomes - pain intensity and disability - and secondary outcomes - mandibular range of motion, pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing - in patients with chronic painful TMD. This study will be a randomized controlled trial with a sample of 148 participants. Individuals will undergo a screening process to identify those with TMD diagnosis according to the Diagnostic Criteria for Temporomandibular Disorders (DC\u002FTMD), aged 20 to 60 years, of both genders, and then the volunteers will be randomized into two groups (G1: Full dosage mode pain science education program + Manual therapy\u002Forofacial and neck motor exercises vs. G2: Fractioned dosage mode pain science education program + Manual therapy\u002Forofacial and neck motor exercises). These volunteers will be recruited in the city of São Carlos, SP. The intervention will take place twice a week for 8 weeks, administered by a single therapist, each session lasting 1 hour. The primary outcomes will be pain intensity and disability, assessed using the numerical pain rating scale and the Craniofacial Pain and Disability Inventory (CFP-DI), respectively, and the secondary outcomes will be mandibular range of motion, pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing, assessed using the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD), Global Perceived Effect of Improvement scale, Pain Self-Efficacy Questionnaire (PSEQ), CARE Empathy Scale, and Pain Catastrophizing Scale (PCS). For statistical analysis, a Generalized Estimated Equations considering time and groups as factors will be used. A significance level of p\\\u003C0.05 will be considered.",[94],"Temporomandibular Joint Disorders","NOT_YET_RECRUITING","2024-06-07",{"date":98,"type":99},"2024-06-11","ACTUAL",{"date":101,"type":88},"2024-09-01",{"date":103,"type":88},"2027-12-10",{"name":5,"class":6},1]