Masticatory Muscle Activity Using a 24-Hour Wearable Device
RecruitingNCT07861906
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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/sustained 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/depression 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/or 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.
Study details
- Official title
- Reevaluating the Role of Masticatory Muscle Activity in Chronic Myofascial Pain Using a 24-Hour Wearable Device
- Conditions
- Chronic Masticatory Myofascial Pain
- Sponsor
- Midwestern University
- Start date
- 2025-06-01
- Primary completion
- 2027-07-31
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
For the chronic myofascial pain group, the Inclusion Criteria are: * Patients of record of the dental institutes at Midwestern University, College of Dental Medicine-Illinois * Receiving a diagnosis of chronic masticatory myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders after a consult with the orofacial pain specialist * Reporting painful symptomatology on the day of the monitoring * Age 18+ * Ability to connect to the Internet * Ability to read and speak English or Italian language Exclusion Criteria: * Patients undergoing orthodontic treatments * Not on stable medication regimen on the day of the monitoring * Starting to wear an occlusal appliance on the day of the monitoring * Changed occlusal appliance within the past 3 months For the healthy control group, Inclusion Criteria are: * Sex and age-matched otherwise healthy adults (without any pain-related masticatory myofascial pain upon examination) * Patients of record of the dental institutes at Midwestern University, College of Dental Medicine-Illinois * Ability to connect to the Internet * Ability to read and speak English language Exclusion criteria: * Patients undergoing orthodontic treatments * Not on stable medication regimen on the day of the monitoring * Starting to wear an occlusal appliance on the day of the monitoring * Changed occlusal appliance within the past 3 months
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07861906