Masseter Muscle Thickness in Individuals With Chronic Neck Pain

March 9, 2026 updated by: Tuğba GÖNEN, Hasan Kalyoncu University

Comparison of Masseter Muscle Thickness Measured by Ultrasonography in Individuals With Chronic Neck Pain Compared to Healthy Individuals

The primary objective of our study is to compare the thickness of the masseter muscle, measured by ultrasound, in individuals with chronic neck pain to that of healthy individuals. The secondary objective of the study is to examine the relationships between masseter muscle thickness and pain intensity, neck disability level, pain catastrophizing level, and clinical diagnostic criteria in individuals with chronic neck pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The aim of this study is to evaluate masseter muscle thickness in individuals with chronic neck pain using ultrasonography and to compare it with healthy individuals. Thus, it is intended to reveal possible morphological changes related to the craniomandibular system in chronic neck pain and to determine whether these changes contribute to clinical evaluations. The literature reports that there are biomechanical and neuromuscular connections between the temporomandibular system and the cervical spine, and that changes in masseter muscle activity and morphology may be related to neck pain. The literature emphasizes that there are biomechanical, neuromuscular, and sensory connections between the temporomandibular system and the cervical spine, and that dysfunctions in these two regions may influence each other reciprocally. The masseter muscle, in particular, being one of the primary muscles of the temporomandibular system, may exhibit increased muscle activity, parafunctional habits, and morphological adaptations due to central sensitization mechanisms in chronic pain conditions. Chronic neck pain is reported to be more common in individuals with temporomandibular disorders, along with increased muscle sensitivity and functional limitations, and this condition is associated with cervical pain severity and disability level. Ultrasonography is a reliable, valid, and non-invasive method for assessing muscle thickness and is widely used to evaluate the morphological characteristics of the masseter muscle. Measuring masseter muscle thickness by ultrasonography allows for the evaluation of the muscle's structural response to functional loading and enables comparisons between different clinical groups. However, the literature shows that studies comparing possible changes in masseter muscle thickness in individuals with chronic neck pain with healthy individuals are limited, and this relationship has not been sufficiently elucidated. Accordingly, the primary objective of this study is to compare the masseter muscle thickness measured by ultrasonography in individuals with chronic neck pain with that in healthy individuals. The secondary objective of the study is to examine the relationships between masseter muscle thickness and pain intensity, neck disability level, pain catastrophizing level, and clinical diagnostic criteria in individuals with chronic neck pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey (Türkiye), 27000
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will include individuals aged 18-45 who have experienced neck pain for at least 3 months but do not have a diagnosed cervical pathology. The control group will include individuals aged 18-45 who do not have any health problems.

Description

Inclusion Criteria:

  • Be between the ages of 18 and 45
  • Have neck pain that has persisted for at least 3 months
  • Agree to participate in the study voluntarily and provide written informed consent

Exclusion Criteria:

  • History of cervical spine surgery or severe trauma
  • Diagnosis of cervical radiculopathy, myelopathy, or neurological disease
  • Rheumatic, inflammatory, or systemic musculoskeletal diseases
  • Diagnosed temporomandibular joint disorder (TMD)
  • Diagnosis of bruxism or a pronounced habit of teeth clenching/grinding
  • History of manual therapy, injection, or surgical intervention in the face, jaw, or neck region within the last 6 months
  • Currently undergoing orthodontic treatment or history of orthodontic treatment within the last 6 months
  • Cognitive impairment or conditions that prevent understanding and responding to questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Chronic neck pain group
The study will include individuals aged 18-45 who have experienced neck pain for at least 3 months but do not have a diagnosed cervical pathology.
Healthy Group
The control group will also include individuals aged 18-45 with no health problems.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ultrasonographic Measurement
Time Frame: through of the study, average 3 months
Masseter muscle thickness will be assessed using the B-mode ultrasound method with a 7.5-10 MHz frequency linear probe on an ALEXUS brand ultrasound device. During measurements, participants will be positioned sitting upright, with the head in a neutral position and the jaw at rest (teeth not in occlusion). Prior to measurement, participants will be instructed to avoid activities such as intense chewing or gum chewing for the last 24 hours. The measurement point will be determined as the midpoint of the line between the zygomatic arch and the mandibular angle. The linear probe will be placed parallel to the long axis of the masseter muscle fibers, perpendicular to the skin surface, and with minimal pressure applied. The ultrasound image will clearly distinguish the skin, subcutaneous tissue, and superficial and deep fascial borders of the masseter muscle.
through of the study, average 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: through of the study, average 3 months
The VAS is a one-dimensional measurement tool used to assess the intensity of pain as perceived by the individual. The scale consists of a horizontal line with endpoints defined as "0 = no pain" and "10 = unbearable pain," on which the individual marks their current pain level. Participants are asked to rate the intensity of their neck pain, and the distance from the starting point to the marked point is measured in centimeters or millimeters and scored. Higher scores indicate higher pain intensity.
through of the study, average 3 months
Neck Disability Index - NDI
Time Frame: through of the study, average 3 months
The Neck Disability Index (NDI) is a multidimensional self-report scale developed to assess the level of functional limitation associated with neck pain, covering activities of daily living. The scale consists of a total of 10 items covering pain, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and recreation. Each item is scored from 0 to 5, and the total score ranges from 0 to 50. Higher scores indicate an increased level of disability related to the neck. The validity and reliability study of the 7-item questionnaire in Turkish was conducted by Emine Aslan and colleagues in 2008.
through of the study, average 3 months
Pain Catastrophizing Scale
Time Frame: through of the study, average 3 months
The Pain Catastrophizing Scale was developed to assess an individual's negative cognitive and emotional responses to their pain experience. The scale consists of three subscales: rumination (persistent thinking), magnification, and helplessness. The scale is answered using a Likert-type rating, and a total score is calculated. High scores indicate an increased tendency to catastrophize pain.
through of the study, average 3 months
Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame: through of the study, average 3 months
The Northwick Park Neck Pain Questionnaire (NPQ) is a self-report measure that assesses functional impairment and symptom severity associated with neck pain. The scale consists of items covering pain, paresthesia, sleep, social life, and daily activities. Participants select the statement that best applies to them for each item. The total score reflects the level of functional impairment, with higher scores indicating greater disability and symptom severity.
through of the study, average 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tuğba GÖNEN, Asisst. Prof. Dr., Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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