Effects of Cervical Manual Therapy for Temporomandibular Disorders With Myalgia

NCT07647887 | Not Yet Recruiting

• 1 other identifier: NYCU114159AF
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Temporomandibular Disorders (TMDs)

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Before and immediately after the intervention

Secondary Outcomes (4)

• Cortical excitability of M1 as assessed by Magstim transcranial magnetic stimulator

  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)

  Before and immediately after the intervention

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

  Before and immediately after the intervention

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

  Before and immediately after the intervention

Study Arms (2)

Upper cervical mobilization

EXPERIMENTAL

Other: upper cervical mobilization

Control group

PLACEBO COMPARATOR

Other: placebo maneuver

Interventions

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.

Upper cervical mobilization

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 60 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 15, 2026

Record last verified: 2025-10