Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain

November 9, 2020 updated by: National Yang Ming University
Temporomandibular disorder (TMD) is a collective term for pain and dysfunction of the masticatory muscles and temporomandibular joint (TMJ). Typical signs and symptoms of TMD includes regional pain, noises from the TMJs and limitations in jaw movements. Altered jaw kinematics and muscle activity have also been reported. TMD may be related to neck problems. Over 50% of patients with TMD suffer from nonspecific neck pain. Patients with TMD often have symptoms over neck, including upper cervical spine movement impairment and reduced cervical muscles endurance. Conversely, TMD may also develop in patients with neck pain. Twenty to thirty-three percent of patients with neck pain also have TMD. Subjects with neck pain present with a twofold higher prevalence of TMD than those without neck pain. In patients with neck pain, the development or perpetuation of TMD may be due to the anatomical connection between TMJ and neck: neck posture affects the mandible position and sensory inputs from the cervical-mandibular region converge at the trigemino-cervical nucleus. Early identification of TMD is essential but to our knowledge, no study has investigated whether patients with neck pain demonstrate altered jaw movement and muscle activity, which is associated with TMD. The purposes of this proposal are to compare the jaw kinematics, muscle activity and muscle sensitivity in healthy individuals and patients with non-specific chronic neck pain (NCNP). This study also aimed to investigate the relationship between forward-head posture and the jaw kinematics, muscle activity as well as muscle sensitivity. With a cross-sectional exploratory study design, 30 healthy control subjects and 30 subjects with NCNP will be recruited. Clinical assessments will include cervical range of motion (CROM), pressure pain threshold (PPT) over the cervical-mandibular region and the cranial-cervical angle (CCA). Jaw kinematics will be measured by Ultrasonic Jaw Motion Analyzer (Zebris GmbH) during functional jaw movements. Muscle activities are record from bilateral anterior temporalis, masseter, sternocleidomastoid muscle and upper trapezius by surface electromyography during resting and clenching.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 (Actual)

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.
44

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang-Ming 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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with nonspecific chronic neck pain for at least 3 months and the matched healthy control subjects

Description

Inclusion Criteria (nonspecific chronic neck pain group):

  • Aged between 20 to 65 years old
  • Mechanical pain that provoked by sustained neck postures or specific neck movements without any identifiable diseases or structure anomalies
  • Chronic or recurrent neck pain of at least 3 months duration
  • Minimum of 3 points on the numerical pain rating scale (NPRS) over cervical region
  • Without any pain, clicking or range of motion limitation over TMJ

Inclusion Criteria (healthy control group):

  • Age (± 5 years) and gender match to NCNP group
  • No pain or clinical pathology involving the masticatory system or cervical spine for at least one year prior to the start of the study

Exclusion Criteria (both groups):

  • Serious injury, tumor, infection
  • Recent cervical-cranial surgery
  • Neurologic involvement
  • Inflammatory rheumatic diseases
  • Pregnancy
  • Nonmechanical cause of neck pain (e.g. herniated disk, spinal fractures)
  • Had been diagnosed with spinal conditions (e.g. spondylolisthesis)
  • Shoulder pain within 1 years
  • Loss of posterior tooth
  • Dental pain or periodontal problems
  • Orthodontic, orofacial myofunctional or TMD treatment within 3 months
  • Use of analgesic or anti-inflammatory drugs within 3 days

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Nonspecific chronic neck pain (NCNP) group
Subjects with nonspecific chronic neck pain will be included to perform clinical test and assess their jaw kinematics and muscle activation.
Other: Cervical range of motion (CROM)
Subjects will perform full-range cervical flexion, extension, side-bending and rotation actively in sitting position. In supine position, cervical flexion-rotation will be performed passively by the assessor.
Other: Pressure pain threshold (PPT)
A digital algometer with rubber head will be used to apply pressure on the muscles of subjects. When the subjects start to feel pain, the algometer will be removed immediately.
Other: Cranial-cervical angle (CCA)
Subjects will stand in a relaxed position with colour markers on the earlobe and C7 spinous process. A photo of the head posture will be taken to calculate the included angle between the markers and the horizontal line.
Other: Jaw kinematics
Jaw kinematics is measured by Ultrasonic Jaw Motion Analyzer (Zebris). The subjects will perform jaw opening, closing, lateral left, lateral right and protrusion for three times.
Other: Muscle activation
Surface electromyography is used to assess the activities of bilateral masseter, anterior temporalis, sternocleidomastoid muscle and upper trapezius. Subjects will perform jaw resting and clenching.
Control group
Healthy control subjects will be included to compare the differences in jaw kinematics, muscle activation and clinical tests between healthy subjects and subjects with nonspecific chronic neck pain. Subjects in this group will received the same assessment as the NCNP group.
Other: Cervical range of motion (CROM)
Subjects will perform full-range cervical flexion, extension, side-bending and rotation actively in sitting position. In supine position, cervical flexion-rotation will be performed passively by the assessor.
Other: Pressure pain threshold (PPT)
A digital algometer with rubber head will be used to apply pressure on the muscles of subjects. When the subjects start to feel pain, the algometer will be removed immediately.
Other: Cranial-cervical angle (CCA)
Subjects will stand in a relaxed position with colour markers on the earlobe and C7 spinous process. A photo of the head posture will be taken to calculate the included angle between the markers and the horizontal line.
Other: Jaw kinematics
Jaw kinematics is measured by Ultrasonic Jaw Motion Analyzer (Zebris). The subjects will perform jaw opening, closing, lateral left, lateral right and protrusion for three times.
Other: Muscle activation
Surface electromyography is used to assess the activities of bilateral masseter, anterior temporalis, sternocleidomastoid muscle and upper trapezius. Subjects will perform jaw resting and clenching.

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
Jaw maximum range of motion
Time Frame: Immediately during the experiment
Including maximum mouth opening, lateral right, lateral left, and protrusion, which will be described with millimeter (mm)
Immediately during the experiment
Jaw velocity
Time Frame: Immediately during the experiment
Jaw opening and closing velocity, which will be described with millimeter per second (mm/s)
Immediately during the experiment
Condylar rotation
Time Frame: Immediately during the experiment
The rotation will be described with degree (°).
Immediately during the experiment
Condylar translation
Time Frame: Immediately during the experiment
Including condylar translation and condylar path length, which will be described with millimeter (mm)
Immediately during the experiment
Muscle activation
Time Frame: Immediately during the experiment
The root mean square of electromyography (EMG) data of the masseter, anterior temporalis, sternocleidomastoid muscle and upper trapezius will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %).
Immediately during the experiment

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
Cervical and jaw range of motion
Time Frame: Immediately during the experiment
Including range of motion of cervical flexion, cervical extension, cervical side-bending,cervical rotation and cervical flexion-rotation as well as maximum mouth opening, jaw lateral right, jaw lateral left, protrusion. The motion will be described with degree (°).
Immediately during the experiment
Pressure pain threshold
Time Frame: Immediately during the experiment
Pressure pain threshold of masseter, anterior temporalis, sternocleidomastoid muscle, upper trapezius and suboccipitals will each be averaged and will be described with kg/cm2.
Immediately during the experiment
Cranial-cervical angle
Time Frame: Immediately during the experiment
Cranial-cervical angle will be measured as the included angle between the ear lobe, C7 spinous process and the horizontal line and will be described with degree (°).
Immediately during the experiment

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.
National Yang Ming University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cheng-Hsin General Hospital

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 (Actual)

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.
October 11, 2019

Primary Completion (Actual)

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.
August 30, 2020

Study Completion (Actual)

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.
August 30, 2020

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).
July 28, 2019

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.
July 31, 2019

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.
August 1, 2019

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.
November 10, 2020

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.
November 9, 2020

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.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • (717)108A-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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