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NCT Number: NCT07647887

Effects of Cervical Manual Therapy for Temporomandibular Disorders With Myalgia

Background: Temporomandibular disorders (TMDs) are the leading cause of non-odontogenic orofacial pain interfering with daily activities. TMDs consist of a group of conditions affecting the masticatory muscles, the temporomandibular joint (TMJ), or the associated structures. Previous studies showed alterations in TMJ kinematics, cortical excitability, electromyographic (EMG) activity of the masticatory muscles, and tongue pressure in individuals with TMDs compared to healthy controls. Furthermore, several studies have demonstrated that manual therapy applied to the cervical joint could reduce pain and improve jaw function in individuals with TMDs. However, the effects of upper cervical mobilization on TMJ kinematics, cortical excitability, tongue pressure, and EMG of masticatory muscles during mouth opening in individuals with myogenous TMDs remain unknown.

Purpose: This study aims to investigate the immediate effects of upper cervical mobilization on TMJ kinematics, EMG of masticatory system muscles, cortical excitability, and tongue pressure in individuals with myogenous TMDs.

Methods: A randomized controlled trial will be conducted with a total sample size of 48 participants. Individuals diagnosed with myogenous TMDs, defined as chronic myalgia (lasting >3 months continuously or > 6 months intermittently) according to the Diagnostic Criteria for Temporomandibular Disorders, will be recruited for this study. Participants will be randomly assigned to either the experimental or the control group, stratified by age and sex. The experimental group will receive a single session of upper cervical mobilization, while the control group will receive a placebo maneuver. The primary outcomes will include TMJ kinematics and EMG activity of the masseter and suprahyoid muscles, while the secondary outcomes will include cortical excitability, tongue pressure, pain intensity, and upper cervical mobility. All measurements will be taken before and immediately after the intervention.

Statistical analysis: The continuous and categorical variables of clinical and demographic characteristics will be analyzed by an independent t test/Mann-Whitney U test and a Chi-square test, respectively. A 2×2 mixed-model analysis of variance (ANOVA) will be used to analyze the outcome measures and to test the main effects and interactions between time and group. If there is a significant interaction effect, post hoc pairwise comparisons with Bonferroni correction will be used. The alpha level is set at 0.05.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with myogenous TMDs, defined as chronic myalgia (lasting >3 months continuously or > 6 months intermittently) 90 with or without accompanying arthralgia according to DC/TMD criteria
  • A visual analogue scale (VAS) score of 3 or greater at baseline
  • 18 to 60 years of age

Exclusion criteria

  • Diagnosed with disc displacement without reduction or degenerative joint disease according to the DC/TMD criteria
  • A diagnosis of systemic diseases such as fibromyalgia, rheumatoid arthritis, systemic erythematous lupus, or psoriatic arthritis
  • A diagnosis of neurological disorders (e.g., trigeminal neuralgia, cervical radiculopathy, or myelopathy)
  • Evidence of central nervous system involvement (positive pathological reflexes)
  • A history of traumatic injuries (e.g., contusion, fracture, or whiplash injury) in the last 6 weeks
  • Signs of vertebral artery insufficiency or upper cervical instability revealed by physical examination
  • Receiving cervical spine mobilization or manipulation or acupuncture for their TMDs within the last 1 week
  • any contraindication to TMS

Treatment and study plan

Upper cervical mobilization

Other

Upper cervical mobilization will focus on the atlanto-axial joint. All techniques will adhere to the International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) guidelines to minimize the risk of adverse effects 75. Participants will remain in a supine position with their head in a neutral alignment. The physical therapist will apply translatoric mobilization, aligning the transverse process of the atlas (C1) as closely as possible with the transverse process of the axis (C2) in the transverse plane. The intervention will be considered complete once C1 and C2 are properly aligned.

placebo maneuver

Other

Participants will also remain in a supine position with a neutral head posture. However, instead of performing mobilization, the physical therapist will simply place their hands on C1 and C2 without applying any force.

Primary outcomes

  1. Range of maximum mouth opening as assessed by Zebris Jaw Motion Analyzer device

    Time frame: Before and immediately after the intervention

    Data will be presented in millimeters. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.

  2. Range of mandibular protrusion as assessed by Zebris Jaw Motion Analyzer device

    Time frame: Before and immediately after the intervention

    Data will be presented in millimeters. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.

  3. Range of mandibular lateral excursion as assessed by Zebris Jaw Motion Analyzer device

    Time frame: Before and immediately after the intervention

    Data will be presented in millimeters. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.

  4. Condylar path length as assessed by Zebris Jaw Motion Analyzer device

    Time frame: Before and immediately after the intervention

    Data will be presented in millimeters. Data will be collected during mouth opening and closing. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.

  5. Condylar rotation as assessed by Zebris Jaw Motion Analyzer device

    Time frame: Before and immediately after the intervention

    Data will be presented in degrees. Data will be collected during mouth opening and closing. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.

  6. Condylar translation as assessed by Zebris Jaw Motion Analyzer device

    Time frame: Before and immediately after the intervention

    Data will be presented in millimeters. Data will be collected during mouth opening and closing. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.

  7. Activation of masseter muscles as assessed by surface electromyography (sEMG) (BIOPAC MP150 system)

    Time frame: Before and immediately after the intervention

    sEMG recordings will be acquired during both TMJ kinematic assessments and maximum voluntary clenching (MVC) tasks.

    To standardize the results, sEMG amplitudes from the kinematic tests will be presented as normalized values (%MVC), calculated as the ratio of task-specific sEMG activity to the maximal activity recorded during MVC.

  8. Activation of suprahyoid muscles as assessed by surface electromyography (sEMG) (BIOPAC MP150 system)

    Time frame: Before and immediately after the intervention

    sEMG recordings will be acquired during both TMJ kinematic assessments and maximum voluntary clenching (MVC) tasks.

    To standardize the results, sEMG amplitudes from the kinematic tests will be presented as normalized values (%MVC), calculated as the ratio of task-specific sEMG activity to the maximal activity recorded during MVC.

Secondary outcomes

  1. Cortical excitability of M1 as assessed by Magstim transcranial magnetic stimulator

    Time frame: Before and immediately after the intervention

    Resting motor threshold, motor evoked potentials, short-interval intracortical inhibition, and intracortical facilitation of masseter muscle will be collected.

    LabChart 8 will be used for data collection and statistical analysis.

  2. Maximum tongue pressure values as assessed by wireless tongue pressure measurement device (OCPT-168, Shi-Heng Technology Co. Ltd., Taiwan)

    Time frame: Before and immediately after the intervention

    Data will be presented as kPa. The subject was asked to perform the maximum tongue protrusion force that could be exerted.

  3. Self reported masticatory muscle pain intensity as assessed by Visual Analog Scale

    Time frame: Before and immediately after the intervention

    Zero is equivalent to no pain, and 10 indicates the worst possible pain.

  4. Upper cervical mobility as assessed by flexion-rotation test at atlanto-axial level

    Time frame: Before and immediately after the intervention

    A cervical range of motion device will be used to measure rotation.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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