[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659228":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":41,"armGroups":42,"interventions":37,"overallOfficials":37,"centralContacts":49,"locations":55,"responsibleParty":71,"collaborators":37,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":37,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":37,"enrollmentInfo":84,"targetDuration":37,"studyType":87,"phases":37,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":57,"whyStopped":37,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Midwestern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Self-reported parafunctional behaviors","Self-reported parafunctional behaviors will be assessed using the Oral Behavior Checklist (OBC), a validated instrument to evaluate frequency, type, and overall burden of awake and sleep self-reported oral parafunctional behaviors (e.g., tooth clenching, grinding, jaw bracing, and other repetitive jaw activities). Answers will be rated on a 5-point Likert scale (from 0 = \"None of the time\" to 4 = \"4-7 nights\u002Fweek\"), and item scores will be summed to obtain a total score ranging from 0 to 84, with higher scores indicating a greater frequency and overall burden of self-reported oral parafunctional behaviors.","Baseline, before the 24-hour assessment period",{"measure":14,"description":15,"timeFrame":16},"EMG-recorded masticatory muscle activity","Objective EMG-recorded masticatory muscle activity will be collected using the dia-BRUXO, a single-recording channel wireless portable electromyograph.","During the 24-hour assessment period",[18,22,26,30,34],{"measure":19,"description":20,"timeFrame":21},"Emotional distress","Emotional distress (in terms of anxiety\u002Fdepression symptomatology) will be assessed using the Patient Health Questionnaire (PHQ-4), a 4-item validated instrument tool inquiring about frequency of anxiety and depression symptomatology. Answers will be rated on a Likert scale (from 0 = \"None\" to 3 = \"Nearly every day\"). Item scores will be summed to obtain a total score ranging from 0 to 12, with cutoff values at 3, 6, and 9 reflecting mild, moderate, and severe anxiety and depression symptomatology.","At baseline, before the 24-hour assessment period",{"measure":23,"description":24,"timeFrame":25},"Stress symptomatology","Stress symptoms will be assessed using the Perceived Stress Scale (PSS), a 10-item validated instrument tool that measures how life circumstances affect adaptive capacity and perceived stress symptoms over the past month.41 Answer will be rated on a Likert scale and ranges from 0 (= \"Never\") to 4 (= \"Very often\"). Items 4, 5, 7, and 8 will reflect four positive items and will be reversed-scored before computing the final score. A total score will be obtained by summing all individual item scores and ranges from 0 to 40, interpreted as mild (0-13), moderate (14-26), and severe (27-40) stress symptomatology.","at baseline, before the 24-hour assessment period, as well as self-reported during the ecologic momentary assessment during the 24-hour assessment",{"measure":27,"description":28,"timeFrame":29},"Insomnia symptomatology","Insomnia symptoms will be assessed using the Insomnia Severity Index (ISI), a 7-item validated instrument tool measuring sleep difficulties in the previous 2 weeks. Answers will be rated on a Likert scale and ranges from 0 (= \"None\" or \"Very satisfied\") to 4 (= \"Very severe\" to \"Very dissatisfied\"). A total score will be obtained by summing all the individual item scores and ranges from 0 to 28, where a cutoff of ISI \\>11 suggests clinically meaningful insomnia.","at baseline, before the 24-hour assessment period",{"measure":31,"description":32,"timeFrame":33},"Pain intensity","Assessed using the Graded Chronic Pain Scale (GCPS), an 8-item validated tool inquiring about pain and interference within the past month. Characteristic Pain Intensity (CPI) will be calculated by averaging the scores of three items assessing \"pain right now\", \"average pain in the last 30 days\", and \"worse pain in the last 30 days\". Each item will be rated on an 11-point numerical rating scale ranging from 0 (= \"No pain\") to 10 (= \"Worst imaginable pain\"). The mean score will then be multiplied by 10 to yield a CPI score ranging from 0 to 100, with higher values indicating greater pain intensity.","at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period",{"measure":35,"description":36,"timeFrame":33},"Pain-related interference","Assessed using the Graded Chronic Pain Scale (GCPS), an 8-item validated tool inquiring about pain and interference within the past month. Pain-related interference (from 0 to 10) will be calculated by averaging the scores of three items assessing the extent to which pain has interfered with \"usual activities\", \"recreational, social, and family activities\", and \"ability to work\", all during the last 30 days. The mean score will then be multiplied by 10 to yield a pain interference scores ranging from 0 to 100, with higher values indicating higher interference",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"CASE_CONTROL","PROSPECTIVE","Participants will be recruited from patients seen at the dental institutes at the Midwestern University, College of Dental Medicine-Illinois (Downers Grove, Illinois, USA)",[43,46],{"label":44,"type":37,"description":45,"interventionNames":37},"Chronic masticatory myofascial pain","Adult patients of the dental institutes, with a clinician-confirmed diagnosis of chronic (\\>3 months) myofascial pain.",{"label":47,"type":37,"description":48,"interventionNames":37},"Healthy controls","Sex- and age-matched otherwise healthy adults visiting the dental institute for recall visits, without any pain-related TMD or any other orofacial pain complaint",[50],{"name":51,"role":52,"phone":53,"phoneExt":37,"email":54},"Linda Sangalli","CONTACT","630-743-4617","lsanga@midwestern.edu",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Downers Grove","Illinois","60515","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-88.01117,41.80892,{"lat":67,"lon":66},[70],{"name":51,"role":52,"phone":53,"phoneExt":37,"email":54},{"type":72,"investigatorFullName":51,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Clinical Assistant Professor","100659228","masticatory-muscle-activity-using-a-24-hour-wearable-device-100659228",false,"NCT07861906","Masticatory Muscle Activity Using a 24-Hour Wearable Device","Reevaluating the Role of Masticatory Muscle Activity in Chronic Myofascial Pain Using a 24-Hour Wearable Device","For the chronic myofascial pain group, the Inclusion Criteria are:\n\n* Patients of record of the dental institutes at Midwestern University, College of Dental Medicine-Illinois\n* Receiving a diagnosis of chronic masticatory myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders after a consult with the orofacial pain specialist\n* Reporting painful symptomatology on the day of the monitoring\n* Age 18+\n* Ability to connect to the Internet\n* Ability to read and speak English or Italian language\n\nExclusion Criteria:\n\n* Patients undergoing orthodontic treatments\n* Not on stable medication regimen on the day of the monitoring\n* Starting to wear an occlusal appliance on the day of the monitoring\n* Changed occlusal appliance within the past 3 months\n\nFor the healthy control group, Inclusion Criteria are:\n\n* Sex and age-matched otherwise healthy adults (without any pain-related masticatory myofascial pain upon examination)\n* Patients of record of the dental institutes at Midwestern University, College of Dental Medicine-Illinois\n* Ability to connect to the Internet\n* Ability to read and speak English language\n\nExclusion criteria:\n\n* Patients undergoing orthodontic treatments\n* Not on stable medication regimen on the day of the monitoring\n* Starting to wear an occlusal appliance on the day of the monitoring\n* Changed occlusal appliance within the past 3 months",true,"ALL","18 Years",{"count":85,"type":86},50,"ESTIMATED","OBSERVATIONAL","Patients with chronic masticatory myofascial pain (MFP) often report that stress and parafunctional oral habits aggravate their pain, consistent with the widespread belief that stress and parafunctional habits lead to increased\u002Fsustained jaw muscle activity and subsequent pain. Yet, these assumptions have never been directly tested, given the lack of tools to measure masticatory muscle activity in real-world settings. This protocol describes a prospective, longitudinal, case-control observational study that will enroll 50 patients total (25 with clinician-diagnosed chronic MFP and 25 age- and sex-matched healthy controls) from the university-based dental clinics at Midwestern University, Illinois. Consenting participants will be instructed to complete a baseline biopsychosocial battery assessing self-reported awake and sleep bruxism (using the Oral Behavior Checklist, OBC), anxiety\u002Fdepression symptoms (using the Patient Health Questionnaire, PHQ-4), perceived stress (using the Perceived Stress Scale, PSS), insomnia symptoms (using the Insomnia Severity Index, ISI) and chronic pain intensity (using the Graded Chronic Pain Scale, GCPS). All participants will be provided a 24-hour electromyograph (EMG) device (dia-BRUXO, Biotech-Novations, Sanremo, Italy) placed on the left masseter, recording jaw muscle activity. Brief ecological momentary assessments will be sent during the 24-hour period, assessing pain intensity, self-reported parafunctional habits, stress and anxiety. The primary aim will be to establish if self-reported awake and sleep bruxism and\u002For biopsychosocial distress are as-sociated with EMG-recorded masticatory muscle activity. The secondary aim will test if masticatory muscle activity is associated with jaw pain intensity.",[90],"Chronic Masticatory Myofascial Pain",[92,93,94,95,96,97,98],"masticatory myofascial pain","temporomandibular disorders","ecologic momentary assessment","ambulatory EMG activity","orofacial pain","parafunctional activities","clenching","2026-10-01",{"date":101,"type":102},"2026-10-06","ACTUAL",{"date":104,"type":102},"2025-06-01",{"date":106,"type":86},"2027-09-30",{"name":5,"class":6},1]