Temporomandibular Disorders (TMDs)NCT07647887
Effects of Cervical Manual Therapy for Temporomandibular Disorders With Myalgia
A study testing upper cervical mobilization in people with Temporomandibular Disorders (TMDs), run by National Yang Ming Chiao Tung University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders (TMDs)
- What is being tested?
- upper cervical mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read more
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.
- Conditions
- Temporomandibular Disorders (TMDs)
- Being tested
- upper cervical mobilization, placebo maneuver
- 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.
upper cervical mobilizationOther
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 maneuverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper cervical mobilization | Experimental | Not described Receives: Other: upper cervical mobilization |
| Control group | Placebo comparator | Not described Receives: Other: placebo maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of maximum mouth opening as assessed by Zebris Jaw Motion Analyzer device
Data will be presented in millimeters. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.
Measured: Before and immediately after the intervention
Range of mandibular protrusion as assessed by Zebris Jaw Motion Analyzer device
Data will be presented in millimeters. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.
Measured: Before and immediately after the intervention
Range of mandibular lateral excursion as assessed by Zebris Jaw Motion Analyzer device
Data will be presented in millimeters. WinJaw software (Zebris Medical GmbH, Isny, Germany) will be used to collect and calculate the data.
Measured: Before and immediately after the intervention
Condylar path length as assessed by Zebris Jaw Motion Analyzer device
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.
Measured: Before and immediately after the intervention
Condylar rotation as assessed by Zebris Jaw Motion Analyzer device
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.
Measured: Before and immediately after the intervention
Condylar translation as assessed by Zebris Jaw Motion Analyzer device
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.
Measured: Before and immediately after the intervention
Activation of masseter muscles as assessed by surface electromyography (sEMG) (BIOPAC MP150 system)
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.
Measured: Before and immediately after the intervention
Activation of suprahyoid muscles as assessed by surface electromyography (sEMG) (BIOPAC MP150 system)
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.
Measured: Before and immediately after the intervention
Secondary outcomes (4)
Cortical excitability of M1 as assessed by Magstim transcranial magnetic stimulator
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.
Measured: 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)
Data will be presented as kPa. The subject was asked to perform the maximum tongue protrusion force that could be exerted.
Measured: Before and immediately after the intervention
Self reported masticatory muscle pain intensity as assessed by Visual Analog Scale
Zero is equivalent to no pain, and 10 indicates the worst possible pain.
Measured: Before and immediately after the intervention
Upper cervical mobility as assessed by flexion-rotation test at atlanto-axial level
A cervical range of motion device will be used to measure rotation.
Measured: Before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647887
- Sponsor's protocol ID
- NYCU114159AF
- Status last verified
- Oct 2025
- First submitted
- 17 Dec 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Manual Therapy for Temporomandibular Disorders With Myalgia
- ClinicalTrials.gov ID
- NCT07647887
- Acronym / sponsor ID
- NYCU114159AF
- Conditions
- Temporomandibular Disorders (TMDs)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jun 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper cervical mobilization | Experimental | Other: upper cervical mobilization |
| Control group | Placebo comparator | Other: placebo maneuver |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| upper cervical mobilizationUpper 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. | Other | Upper cervical mobilization |
| placebo maneuverParticipants 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. | Other | Control group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Cortical excitability of M1 as assessed by Magstim transcranial magnetic stimulator
Time frame: 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
Self reported masticatory muscle pain intensity as assessed by Visual Analog Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing upper cervical mobilization in people with Temporomandibular Disorders (TMDs), run by National Yang Ming Chiao Tung University.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Range of maximum mouth opening as assessed by Zebris Jaw Motion Analyzer device (time frame: Before and immediately after the intervention). The study lists 8 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 15 Jun 2026.