Temporomandibular DisorderNCT04041271
Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain
An observational study of Temporomandibular Disorder and Nonspecific Chronic Neck Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Temporomandibular Disorder, Nonspecific Chronic Neck Pain, Biomechanical Phenomena
- What is being tested?
- Cervical range of motion (CROM), Pressure pain threshold (PPT) and Cranial-cervical angle (CCA)
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2019to 30 Aug 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Adult
Study population: Patients with nonspecific chronic neck pain for at least 3 months and the matched healthy control subjects
Who may be able to join
- 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
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Cervical range of motion (CROM), Pressure pain threshold (PPT), Cranial-cervical angle (CCA), Jaw kinematics, Muscle activation
- Keywords
- Temporomandibular disorder, Nonspecific chronic neck pain, Jaw kinematics, Muscle activity, Muscle sensitivity, Forward head
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical range of motion (CROM)Other
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.
Pressure pain threshold (PPT)Other
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.
Cranial-cervical angle (CCA)Other
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 kinematicsOther
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.
Muscle activationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cervical range of motion (CROM); Other: Pressure pain threshold (PPT); Other: Cranial-cervical angle (CCA); Other: Jaw kinematics; Other: Muscle activation | |
| 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. Receives: Other: Cervical range of motion (CROM); Other: Pressure pain threshold (PPT); Other: Cranial-cervical angle (CCA); Other: Jaw kinematics; Other: Muscle activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw maximum range of motion
Including maximum mouth opening, lateral right, lateral left, and protrusion, which will be described with millimeter (mm)
Measured: Immediately during the experiment
Jaw velocity
Jaw opening and closing velocity, which will be described with millimeter per second (mm/s)
Measured: Immediately during the experiment
Condylar rotation
The rotation will be described with degree (°).
Measured: Immediately during the experiment
Condylar translation
Including condylar translation and condylar path length, which will be described with millimeter (mm)
Measured: Immediately during the experiment
Muscle activation
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, %).
Measured: Immediately during the experiment
Secondary outcomes (3)
Cervical and jaw range of motion
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 (°).
Measured: Immediately during the experiment
Pressure pain threshold
Pressure pain threshold of masseter, anterior temporalis, sternocleidomastoid muscle, upper trapezius and suboccipitals will each be averaged and will be described with kg/cm2.
Measured: Immediately during the experiment
Cranial-cervical angle
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 (°).
Measured: Immediately during the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start11 Oct 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 44 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041271
- Sponsor's protocol ID
- (717)108A-33
- Status last verified
- Sep 2020
- First submitted
- 28 Jul 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04041271
- Acronym / sponsor ID
- (717)108A-33
- Keywords
- Temporomandibular disorder, Nonspecific chronic neck pain, Jaw kinematics, Muscle activity, Muscle sensitivity, Forward head
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 1 Aug 2019 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonspecific chronic neck pain (NCNP) group | – | Other: Cervical range of motion (CROM), Other: Pressure pain threshold (PPT), Other: Cranial-cervical angle (CCA), Other: Jaw kinematics, Other: Muscle activationSubjects with nonspecific chronic neck pain will be included to perform clinical test and assess their jaw kinematics and muscle activation. |
| Control group | – | Other: Cervical range of motion (CROM), Other: Pressure pain threshold (PPT), Other: Cranial-cervical angle (CCA), Other: Jaw kinematics, Other: Muscle activationHealthy 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with nonspecific chronic neck pain for at least 3 months and the matched healthy control subjects
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Serious injury, tumor, infection
- Recent cervical-cranial surgery
- Neurologic involvement
- Inflammatory rheumatic diseases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control group, Nonspecific chronic neck pain (NCNP) group |
| 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 | Control group, Nonspecific chronic neck pain (NCNP) group |
| 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 | Control group, Nonspecific chronic neck pain (NCNP) group |
| Jaw kinematicsJaw 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 | Control group, Nonspecific chronic neck pain (NCNP) group |
| Muscle activationSurface electromyography is used to assess the activities of bilateral masseter, anterior temporalis, sternocleidomastoid muscle and upper trapezius. Subjects will perform jaw resting and clenching. | Other | Control group, Nonspecific chronic neck pain (NCNP) group |
Primary outcome
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)
Jaw velocity
Time frame: Immediately during the experiment
Jaw opening and closing velocity, which will be described with millimeter per second (mm/s)
Condylar rotation
Time frame: Immediately during the experiment
The rotation will be described with degree (°).
Condylar translation
Time frame: Immediately during the experiment
Including condylar translation and condylar path length, which will be described with millimeter (mm)
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, %).
3 secondary outcomes
Cervical and jaw range of motion
Time frame: Immediately during the experiment
Pressure pain threshold
Time frame: Immediately during the experiment
Cranial-cervical angle
Time frame: Immediately during the experiment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Temporomandibular Disorder and Nonspecific Chronic Neck Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 10 Nov 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw maximum range of motion (time frame: Immediately during the experiment). The study lists 5 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 10 Nov 2020.