Effects of Cervical Manual Therapy for Temporomandibular Disorders With Myalgia

June 9, 2026 updated by: National Yang Ming Chiao Tung University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

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

  • Adult

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Other: placebo maneuver
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.
Experimental: Upper cervical mobilization
Other: upper cervical mobilization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention
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.
Before and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming Chiao Tung University

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYCU114159AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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