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Effect of Forward Head Correction on EMG of Masticatory Muscles in Patients With TMD

Primary Purpose

Temporomandibular Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
EMG
Sponsored by
Beirut Arab University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring TMJ pain, EMG activity, cervical pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women/aged between 18-40/ patients suffer from TMJ disorder/ no other treatment such as medications, physical therapy, and joint injections in the past 2 weeks Exclusion Criteria: Previous history of TMG subluxation or dislocation that may interfere with the opening of the mouth/ Neck pain which may affect the head and neck posture/ Head or neck trauma/.Class II or III malocclusion/ posture disorder caused by abnormal curvature of the spine; rheumatic disease; hemorrhagic disease, etc.;/ Lateral deviation of the mandible

Sites / Locations

  • Physical therapy outpatient clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

interventional group

conrol group

Arm Description

The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises based on Harman and Mostafa et al's approach.

General exercises

Outcomes

Primary Outcome Measures

EMG activity
Electrodes will placed on the muscle belly parallel to the direction of muscle fibers. The distance between the two electrodes was 2 cm. The subjects will instructed to complete maximum voluntary contraction (MVC) of clenching the teeth for a period of 3 s and repeated twice. The average of the two trials of MVC will used for further analysis. target muscles include masseter , temporalis, splenius, upper trapezius and sternocleidomastoid muscles.

Secondary Outcome Measures

Measurement of TMJ range of motion.
The subject will instructed to open his mouth as wide as possible without causing pain or discomfort. The rater will measured the intercisal distance by placing one end of the ruler against the incise edge of one of the central incisors, and the other end against the incise edge of the opposing maxillary incisor." TMJ ROM measurements will be taken once for all patients before subdividing into groups and then after treatment intervention methods.
Fonseca's questionnaire
assess the prevalence and severity of temporomandibular disorders.

Full Information

First Posted
February 23, 2023
Last Updated
June 6, 2023
Sponsor
Beirut Arab University
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1. Study Identification

Unique Protocol Identification Number
NCT05756010
Brief Title
Effect of Forward Head Correction on EMG of Masticatory Muscles in Patients With TMD
Official Title
Effect of Forward Head Correction on EMG Activity of Masticatory and Cervical Muscles in Patients With Temporomandibular Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 29, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study aims to investigate the effects of forward head correction exercises on EMG of masticatory and cervical muscles in patients with temporomandibular disorder. The study's design will be double-blinded, randomized controlled trial. Patients suffering from TMD will be included in the program. The participants will allocate to one of two groups at random: the experimental group will perform a program consisting of two strengthening exercises (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) and the control group will receive only neck flexion exercise.. This exercise program will be repeated 4 times per week for 10 weeks, and each session lasted for 30 minutes. The muscle activity EMG of masseter, temporalis, splenius, upper trapezius, and SCM will be measured pre and post-assessment using a biopic data acquisition system.
Detailed Description
1- EMG activity: Electrodes will be placed on the muscle belly parallel to the direction of muscle fibers. The distance between the two electrodes was 2 cm. The subjects will instructs to complete maximum voluntary contraction (MVC) by clenching the teeth for 3 s and repeating twice. The average of the two trials of MVC was used for further analysis. To test the masseter and temporalis muscles: The subjects will be seated on a stable chair and will be instructed to tightly bite a cotton roll 10 mm thick as much as possible. To test splenius muscle: the subjects will be seated on a stable chair and the examiner resist head extension. To test the upper trapezius muscle: The subjects will be seated on a stable chair with the head side bent to the opposite side of the tested muscle; the examiner resist head side bending and shoulder elevation. To test the sternocleidomastoid muscle: The subjects will be placed in a supine position and the examiner resisted the movement of cervical flexion by lifting the head from the table, with the chin depressed and approximated toward the sternum. 2. Measurement of TMJ range of motion. An 11 cm plastic ruler marked in millimeters measured TMJ opening range of motion "Opening. The subject will be instructed to open his mouth as wide as possible without causing pain or discomfort. The rater will measured the intercisal distance by placing one end of the ruler against the incise edge of one of the central incisors, and the other end against the incise edge of the opposing maxillary incisor." TMJ ROM measurements will be taken once for all patients before subdividing into groups and then after treatment intervention methods. 3-Use of the Fonseca's questionnaire to assess the prevalence and severity of temporomandibular disorders The Fonseca's questionnaire which considered to be valid and reliable for collecting a large quantity of information in a relatively short period and at low cost, it was easy to understand and had almost no influence from the examiner. -intervention program: The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises based on Harman and Mostafa et al's approach..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
TMJ pain, EMG activity, cervical pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interventional group
Arm Type
Experimental
Arm Description
The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises based on Harman and Mostafa et al's approach.
Arm Title
conrol group
Arm Type
Sham Comparator
Arm Description
General exercises
Intervention Type
Device
Intervention Name(s)
EMG
Other Intervention Name(s)
Forward head correction
Intervention Description
The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises
Primary Outcome Measure Information:
Title
EMG activity
Description
Electrodes will placed on the muscle belly parallel to the direction of muscle fibers. The distance between the two electrodes was 2 cm. The subjects will instructed to complete maximum voluntary contraction (MVC) of clenching the teeth for a period of 3 s and repeated twice. The average of the two trials of MVC will used for further analysis. target muscles include masseter , temporalis, splenius, upper trapezius and sternocleidomastoid muscles.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Measurement of TMJ range of motion.
Description
The subject will instructed to open his mouth as wide as possible without causing pain or discomfort. The rater will measured the intercisal distance by placing one end of the ruler against the incise edge of one of the central incisors, and the other end against the incise edge of the opposing maxillary incisor." TMJ ROM measurements will be taken once for all patients before subdividing into groups and then after treatment intervention methods.
Time Frame
10 weeks
Title
Fonseca's questionnaire
Description
assess the prevalence and severity of temporomandibular disorders.
Time Frame
10 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women/aged between 18-40/ patients suffer from TMJ disorder/ no other treatment such as medications, physical therapy, and joint injections in the past 2 weeks Exclusion Criteria: Previous history of TMG subluxation or dislocation that may interfere with the opening of the mouth/ Neck pain which may affect the head and neck posture/ Head or neck trauma/.Class II or III malocclusion/ posture disorder caused by abnormal curvature of the spine; rheumatic disease; hemorrhagic disease, etc.;/ Lateral deviation of the mandible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lama bassem jarjour, DPT
Phone
70015158
Email
jarjourlama@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed ElMelhat, Professor
Organizational Affiliation
Assistant Prof of Physical Therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Physical therapy outpatient clinic
City
Beirut
ZIP/Postal Code
2334
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed ElMelhat
Phone
01112595022
Email
ahmed.elmelhat@cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Any study records that identify patient will be kept confidential. The records from the participation may be reviewed by people responsible for making sure that research is done properly, including members of the BAU Institutional Review Board. All of these people are required to keep their identities confidential. Otherwise, records that identify patients will be available only to people working on the study. • We will use a code of numbers and alphabets rather than participants' names on data sheets, keeping records in a safe place.
Citations:
PubMed Identifier
30584494
Citation
Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.
Results Reference
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PubMed Identifier
22632591
Citation
Ballenberger N, von Piekartz H, Paris-Alemany A, La Touche R, Angulo-Diaz-Parreno S. Influence of different upper cervical positions on electromyography activity of the masticatory muscles. J Manipulative Physiol Ther. 2012 May;35(4):308-18. doi: 10.1016/j.jmpt.2012.04.020.
Results Reference
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PubMed Identifier
19291503
Citation
Wang MQ, He JJ, Wang K, Svensson P. Influence of changing occlusal support on jaw-closing muscle electromyographic activity in healthy men and women. Acta Odontol Scand. 2009;67(3):187-92. doi: 10.1080/00016350902794800.
Results Reference
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PubMed Identifier
36241923
Citation
Yao Y, Cai B, Fan S, Yang HX, Zhang YX, Xu LL. The association between forward head posture and masticatory muscle pressure pain thresholds in patients with temporomandibular joint dissorders: a cross-sectional observational study. Clin Oral Investig. 2023 Jan;27(1):353-360. doi: 10.1007/s00784-022-04739-9. Epub 2022 Oct 14.
Results Reference
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PubMed Identifier
33691457
Citation
Xu L, Zhang L, Lu J, Fan S, Cai B, Dai K. Head and neck posture influences masticatory muscle electromyographic amplitude in healthy subjects and patients with temporomandibular disorder: a preliminary study. Ann Palliat Med. 2021 Mar;10(3):2880-2888. doi: 10.21037/apm-20-1850. Epub 2021 Mar 3.
Results Reference
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PubMed Identifier
26054969
Citation
Berni KC, Dibai-Filho AV, Pires PF, Rodrigues-Bigaton D. Accuracy of the surface electromyography RMS processing for the diagnosis of myogenous temporomandibular disorder. J Electromyogr Kinesiol. 2015 Aug;25(4):596-602. doi: 10.1016/j.jelekin.2015.05.004. Epub 2015 May 27.
Results Reference
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PubMed Identifier
18990679
Citation
Tecco S, Tete S, D'Attilio M, Perillo L, Festa F. Surface electromyographic patterns of masticatory, neck, and trunk muscles in temporomandibular joint dysfunction patients undergoing anterior repositioning splint therapy. Eur J Orthod. 2008 Dec;30(6):592-7. doi: 10.1093/ejo/cjn052. Epub 2008 Nov 5.
Results Reference
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PubMed Identifier
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Citation
Chaves TC, Dos Santos Aguiar A, Felicio LR, Greghi SM, Hallak Regalo SC, Bevilaqua-Grossi D. Electromyographic ratio of masseter and anterior temporalis muscles in children with and without temporomandibular disorders. Int J Pediatr Otorhinolaryngol. 2017 Jun;97:35-41. doi: 10.1016/j.ijporl.2017.03.022. Epub 2017 Mar 18.
Results Reference
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PubMed Identifier
32872670
Citation
Cuenca-Martinez F, Herranz-Gomez A, Madronero-Miguel B, Reina-Varona A, La Touche R, Angulo-Diaz-Parreno S, Pardo-Montero J, Del Corral T, Lopez-de-Uralde-Villanueva I. Craniocervical and Cervical Spine Features of Patients with Temporomandibular Disorders: A Systematic Review and Meta-Analysis of Observational Studies. J Clin Med. 2020 Aug 30;9(9):2806. doi: 10.3390/jcm9092806.
Results Reference
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Effect of Forward Head Correction on EMG of Masticatory Muscles in Patients With TMD

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