- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041271
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
Completed
Study Type
Observational
Enrollment (Actual)
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
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-
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Taipei, Taiwan, 112
- National Yang-Ming University
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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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
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.
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.
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.
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.
|
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.
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.
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.
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.
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
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)
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Immediately during the experiment
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Jaw velocity
Time Frame: Immediately during the experiment
|
Jaw opening and closing velocity, which will be described with millimeter per second (mm/s)
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Immediately during the experiment
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Condylar rotation
Time Frame: Immediately during the experiment
|
The rotation will be described with degree (°).
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Immediately during the experiment
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Condylar translation
Time Frame: Immediately during the experiment
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Including condylar translation and condylar path length, which will be described with millimeter (mm)
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Immediately during the experiment
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Muscle activation
Time Frame: Immediately during the experiment
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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, %).
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Immediately during the experiment
|
Secondary Outcome Measures
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 (°).
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Immediately during the experiment
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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.
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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 (°).
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Immediately during the experiment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 11, 2019
Primary Completion (Actual)
August 30, 2020
Study Completion (Actual)
August 30, 2020
Study Registration Dates
First Submitted
July 28, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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