NCT04041271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

November 10, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

July 28, 2019

Last Update Submit

November 9, 2020

Conditions

Keywords

Temporomandibular disorderNonspecific chronic neck painJaw kinematicsMuscle activityMuscle sensitivityForward head

Outcome Measures

Primary Outcomes (5)

  • 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

  • Jaw velocity

    Jaw opening and closing velocity, which will be described with millimeter per second (mm/s)

    Immediately during the experiment

  • Condylar rotation

    The rotation will be described with degree (°).

    Immediately during the experiment

  • Condylar translation

    Including condylar translation and condylar path length, which will be described with millimeter (mm)

    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, %).

    Immediately during the experiment

Secondary Outcomes (3)

  • Cervical and jaw range of motion

    Immediately during the experiment

  • Pressure pain threshold

    Immediately during the experiment

  • Cranial-cervical angle

    Immediately during the experiment

Study Arms (2)

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)Other: Pressure pain threshold (PPT)Other: Cranial-cervical angle (CCA)Other: Jaw kinematicsOther: 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.

Other: Cervical range of motion (CROM)Other: Pressure pain threshold (PPT)Other: Cranial-cervical angle (CCA)Other: Jaw kinematicsOther: Muscle activation

Interventions

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.

Control groupNonspecific chronic neck pain (NCNP) group

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.

Control groupNonspecific chronic neck pain (NCNP) group

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.

Control groupNonspecific chronic neck pain (NCNP) group

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.

Control groupNonspecific chronic neck pain (NCNP) group

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 groupNonspecific chronic neck pain (NCNP) group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2019

First Posted

August 1, 2019

Study Start

October 11, 2019

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

November 10, 2020

Record last verified: 2020-09

Locations