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

Primary Purpose

Temporomandibular Joint Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction focused on measuring temporomandibular joint dysfunction, manual therapy, EMG, maximal mouth opening

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bahçeşehir University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Manual therapy

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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).

Full Information

First Posted
June 13, 2022
Last Updated
February 20, 2023
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05420896
Brief Title
Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint Dysfunction.
Official Title
Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction
Keywords
temporomandibular joint dysfunction, manual therapy, EMG, maximal mouth opening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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 Outcome Measure Information:
Title
Electromyography (EMG)
Description
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.
Title
Pain Pressure Threshold (PPT)
Description
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.
Title
Maximum Mouth Opening (MMO)
Description
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.
Title
TAMPA
Description
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.
Title
Functional Limitation Scale of the Jaw-8
Description
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.
Title
Hospital Anxiety Depression Scale (HADS)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kumru Ateş, PhC
Organizational Affiliation
Bahçeşehir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahçeşehir University
City
Istanbul
State/Province
Europe
ZIP/Postal Code
34353
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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