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
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Linda Sangalli
- Número de teléfono: 630-743-4617
- Correo electrónico: lsanga@midwestern.edu
Ubicaciones de estudio
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Illinois
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Downers Grove, Illinois, Estados Unidos, 60515
- Reclutamiento
- Midwestern University
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Contacto:
- Linda Sangalli
- Número de teléfono: 630-743-4617
- Correo electrónico: lsanga@midwestern.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Participants will be recruited from patients seen at the dental institutes at the Midwestern University, College of Dental Medicine-Illinois (Downers Grove, Illinois, USA)
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Chronic masticatory myofascial pain
Adult patients of the dental institutes, with a clinician-confirmed diagnosis of chronic (>3 months) myofascial pain. |
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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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Self-reported parafunctional behaviors
Periodo de tiempo: Baseline, before the 24-hour assessment period
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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
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EMG-recorded masticatory muscle activity
Periodo de tiempo: During the 24-hour assessment period
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emotional distress
Periodo de tiempo: At baseline, before the 24-hour assessment period
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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
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Stress symptomatology
Periodo de tiempo: at baseline, before the 24-hour assessment period, as well as self-reported during the ecologic momentary assessment during the 24-hour assessment
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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
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Insomnia symptomatology
Periodo de tiempo: at baseline, before the 24-hour assessment period
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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
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Pain intensity
Periodo de tiempo: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period
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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
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Pain-related interference
Periodo de tiempo: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades Musculares
- Enfermedades Articulares
- Enfermedades de la mandíbula
- Enfermedades mandibulares
- Trastornos Craneomandibulares
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Trastornos de la articulación temporomandibular
- Dolor facial
Otros números de identificación del estudio
- IRB-25-0038
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual data will be shared upon reasonable request to the corresponding author
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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