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CompletedNCT05420896Updated Feb 21, 2023

Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint Dysfunction.

An interventional study of Manual Therapy in Temporomandibular Joint Dysfunction, sponsored by Bahçeşehir University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Bahçeşehir University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2021, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle activation as a result of symptoms such as pain and limitation of movement. The aim of this study is to examine the efficacy of manual therapy electromyographically in patients with TMD.

Read the detailed description

TMD is a common condition in the community. It may occur due to factors such as trauma, stress, occlusal disorders. Symptoms include pain, limitation in mouth opening, joint voice, postural and psychosocial disorders. TMD/RDC diagnostic criteria are used in the classification of TMD, and accordingly, it is stated that it may originate from the joint, disc and chewing muscles. In the treatment, conservative treatments such as patient education, manual therapy and exercises are applied first.

Manual therapy is an effective physiotherapy method on pain and muscle dysfunctions in musculoskeletal problems. In our study, electromyographic changes of masticatory muscles will be examined by applying manual treatment to the masticatory muscles and cervical region in myofascial TMD patients according to TMD/RC.

02

Conditions studied

  • Temporomandibular Joint Dysfunction

Keywords

  • temporomandibular joint dysfunction
  • manual therapy
  • EMG
  • maximal mouth opening
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 34 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

Bahçeşehir University is the lead sponsor of 117 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • No cognitive impairment
  • Diagnosed with temporomandibular joint(TMJ) dysfunction of myofascial origin,
  • Volunteers aged 18-65

Exclusion criteria

Exclusion Criteria:

  • Malignancy and fracture of the cervical region and/or TMJ
  • Active infection
  • Patients actively receiving cervical and/or TMJ-related therapy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Manual therapy

    Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG.

    Other: Manual Therapy

  • No intervention
    Control group

    Patients assigned to the control group randomly will be re-evaluated 4 weeks after their initial evaluation. No intervention will be applied during this period. After 4 weeks, when the patients are re-evaluated, they will be directed to the appropriate treatment.

Interventions

  • OtherManual Therapy

    Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale (VAS)

    A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

Secondary outcomes

  1. Electromyography (EMG)

    Electromyography (EMG) is the most objective and reliable method available for imaging muscle function and efficiency, which is done by identifying their electrical potentials. In global surface electromyography (sEMG), surface electrodes are located on the surface of the skin, and it detects superimposed motor unit action potentials from many muscle fibers

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

  2. Pain Pressure Threshold (PPT)

    Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle.

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

  3. Maximum Mouth Opening (MMO)

    Maximal opening of mouth is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite. Clinical measurement of normal range of Maximum Mouth Opening (MMO) is an important diagnostic criterion for evaluation of stomatognathic system, especially for those with temporomandibular dysfunctions.

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

  4. TAMPA

    The original Tampa Scale of Kinesiophobiais (TSK) was first developed in 1991 by R. Miller, S. Kopri, and D. Todd. TSK is 12 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

  5. Functional Limitation Scale of the Jaw-8

    It is a scale used to evaluate the functionality of the individual's jaw joint in the last month. It consists of 8 items, where the number '0' indicates 'no restriction' and the number '10' indicates 'serious restriction'. By taking the average of the answers given, the functionality restriction is calculated.

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

  6. Hospital Anxiety Depression Scale (HADS)

    The Hospital Anxiety Depression Scale (HADS) includes two subscales, seven of which measure anxiety (odd numbers) and seven (even numbers) depression, which are used to determine the depression and anxiety levels of individuals, and a total of 14 questions. Each question is scored between 0-3 points. While the minimum score that can be obtained from the depression and anxiety subscales is 0, the maximum score is 21. According to the scores obtained from the subscales, the depression and anxiety status of the individuals are evaluated as normal/no symptoms (0-7 points), borderline abnormal/suspicious (8-10 points), and abnormal/definite (11-21 points).

    Time frame: Change from initial assessment to 4 weeks after initial assessment.

07

Study locations

1 site
  • Bahçeşehir University
    Istanbul, Europe 34353, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05420896
Lead sponsor
Bahçeşehir University
Responsible party
Kumru Ateş (PhD-C, Bahçeşehir University) — Principal investigator
First posted
Jun 15, 2022
Start date
Jun 10, 2021
Primary completion
Sep 5, 2022
Completion
Nov 10, 2022
Last update
Feb 21, 2023

Study contacts

Kumru Ateş, PhC
principal investigator · Bahçeşehir University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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