Chronic Masticatory Myofascial PainNCT07861906
Masticatory Muscle Activity Using a 24-Hour Wearable Device
An observational study of Chronic Masticatory Myofascial Pain, run by Midwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Masticatory Myofascial Pain
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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)
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 13Show fewer
- 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
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Midwestern University
Downers Grove, Illinois, 60515
Linda Sangalli, 630-743-4617, lsanga@midwestern.edu
About this study
Official title: 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.
- Conditions
- Chronic Masticatory Myofascial Pain
- Keywords
- masticatory myofascial pain, temporomandibular disorders, ecologic momentary assessment, ambulatory EMG activity, orofacial pain, parafunctional activities, clenching
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, before the 24-hour assessment period
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.
Measured: During the 24-hour assessment period
Secondary outcomes (5)
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.
Measured: At baseline, before the 24-hour assessment period
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.
Measured: 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
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.
Measured: at baseline, before the 24-hour assessment period
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.
Measured: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period
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
Measured: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jun 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Masticatory Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Sangalli, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861906
- Sponsor's protocol ID
- IRB-25-0038
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual data will be shared upon reasonable request to the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reevaluating the Role of Masticatory Muscle Activity in Chronic Myofascial Pain Using a 24-Hour Wearable Device
- ClinicalTrials.gov ID
- NCT07861906
- Acronym / sponsor ID
- IRB-25-0038
- Conditions
- Chronic Masticatory Myofascial Pain
- Keywords
- masticatory myofascial pain, temporomandibular disorders, ecologic momentary assessment, ambulatory EMG activity, orofacial pain, parafunctional activities, clenching
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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)
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
- Sex and age-matched otherwise healthy adults (without any pain-related masticatory myofascial pain upon examination)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported parafunctional behaviors
Time frame: 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.
EMG-recorded masticatory muscle activity
Time frame: 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.
5 secondary outcomes
Emotional distress
Time frame: At baseline, before the 24-hour assessment period
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 assessment
Insomnia symptomatology
Time frame: at baseline, before the 24-hour assessment period
Pain intensity
Time frame: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period
Pain-related interference
Time frame: at baseline before the 24-hour assessment period and self-reported during the ecologic momentary assessment, during the 24-hour period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual data will be shared upon reasonable request to the corresponding author
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Masticatory Myofascial Pain, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Sangalli (630-743-4617, lsanga@midwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported parafunctional behaviors (time frame: Baseline, before the 24-hour assessment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.