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Masticatory Muscle Activity Using a 24-Hour Wearable Device

1 octobre 2026 mis à jour par: Linda Sangalli, Midwestern University

Reevaluating the Role of Masticatory Muscle Activity in Chronic Myofascial Pain Using a 24-Hour Wearable Device

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

50

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Illinois
      • Downers Grove, Illinois, États-Unis, 60515
        • Recrutement
        • Midwestern University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Participants will be recruited from patients seen at the dental institutes at the Midwestern University, College of Dental Medicine-Illinois (Downers Grove, Illinois, USA)

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: CASE_CONTROL
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Chronic masticatory myofascial pain

Adult patients of the dental institutes, with a clinician-confirmed diagnosis of chronic (>3 months) myofascial pain.
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Self-reported parafunctional behaviors
Délai: Baseline, before the 24-hour assessment period

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/week"), 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
EMG-recorded masticatory muscle activity
Délai: During the 24-hour assessment period

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Emotional distress
Délai: At baseline, before the 24-hour assessment period

Emotional distress (in terms of anxiety/depression 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
Stress symptomatology
Délai: at baseline, before the 24-hour assessment period, as well as self-reported during the ecologic momentary assessment during the 24-hour assessment

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
Insomnia symptomatology
Délai: at baseline, before the 24-hour assessment period

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
Pain intensity
Délai: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period

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
Pain-related interference
Délai: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period

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
at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Midwestern University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2025

Achèvement primaire (Estimé)

31 juillet 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

26 septembre 2026

Première soumission répondant aux critères de contrôle qualité

1 octobre 2026

Première publication (Réel)

6 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-25-0038

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

De-identified individual data will be shared upon reasonable request to the corresponding author

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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