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

February 20, 2023 updated by: Kumru Ateş, Bahçeşehir University

Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Europe
      • Istanbul, Europe, Turkey, 34353
        • Bahcesehir university

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: Change from initial assessment to 4 weeks after initial assessment.
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.
Change from initial assessment to 4 weeks after initial assessment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography (EMG)
Time Frame: Change from initial assessment to 4 weeks after initial assessment.
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
Change from initial assessment to 4 weeks after initial assessment.
Pain Pressure Threshold (PPT)
Time Frame: Change from initial assessment to 4 weeks after initial assessment.
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.
Change from initial assessment to 4 weeks after initial assessment.
Maximum Mouth Opening (MMO)
Time Frame: Change from initial assessment to 4 weeks after initial assessment.
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.
Change from initial assessment to 4 weeks after initial assessment.
TAMPA
Time Frame: Change from initial assessment to 4 weeks after initial assessment.

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.
Change from initial assessment to 4 weeks after initial assessment.
Functional Limitation Scale of the Jaw-8
Time Frame: Change from initial assessment to 4 weeks after initial assessment.
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.
Change from initial assessment to 4 weeks after initial assessment.
Hospital Anxiety Depression Scale (HADS)
Time Frame: Change from initial assessment to 4 weeks after initial assessment.
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).
Change from initial assessment to 4 weeks after initial assessment.

Collaborators and Investigators

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

Sponsor

Bahçeşehir University

Investigators

  • Principal Investigator: Kumru Ateş, PhC, Bahcesehir 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 (Actual)

June 10, 2021

Primary Completion (Actual)

September 5, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BahçesehırÜniversitesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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