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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04041271
Other study ID # (717)108A-33
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 11, 2019
Est. completion date August 30, 2020

Study information

Verified date September 2020
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date August 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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-in?ammatory drugs within 3 days

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.
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.

Locations

Country Name City State
Taiwan National Yang-Ming University Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Yang Ming University Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Jaw maximum range of motion Including maximum mouth opening, lateral right, lateral left, and protrusion, which will be described with millimeter (mm) Immediately during the experiment
Primary Jaw velocity Jaw opening and closing velocity, which will be described with millimeter per second (mm/s) Immediately during the experiment
Primary Condylar rotation The rotation will be described with degree (°). Immediately during the experiment
Primary Condylar translation Including condylar translation and condylar path length, which will be described with millimeter (mm) Immediately during the experiment
Primary 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, %). Immediately during the experiment
Secondary 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 (°). Immediately during the experiment
Secondary 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. Immediately during the experiment
Secondary 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 (°). Immediately during the experiment
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