Masticatory Muscle Activity Using a 24-Hour Wearable Device
ConditionChronic Masticatory Myofascial Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMidwestern University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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+
Disqualifiers
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
Trial population
Participants will be recruited from patients seen at the dental institutes at the Midwestern University, College of Dental Medicine-Illinois (Downers Grove, Illinois, USA)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: Chronic masticatory myofascial pain
Group B: Healthy controls
Trial outcomes
Primary outcomes
1
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/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.
Time frame
Baseline, before the 24-hour assessment period2
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.
Time frame
During the 24-hour assessment periodSecondary outcomes
1
Emotional distress
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.
Time frame
At baseline, before the 24-hour assessment period2
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.
Time frame
at baseline, before the 24-hour assessment period, as well as self-reported during the ecologic momentary assessment during the 24-hour assessment3
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.
Time frame
at baseline, before the 24-hour assessment period4
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.
Time frame
at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour periodSponsors and contacts
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Source ClinicalTrials.gov