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

June 6, 2023 updated by: Rami Abbas, Beirut Arab University

Effect of Forward Head Correction on EMG Activity of Masticatory and Cervical Muscles in Patients With Temporomandibular Disorder

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

  1. 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.
  2. To test splenius muscle: the subjects will be seated on a stable chair and the examiner resist head extension.
  3. 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.
  4. 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..

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

      • Beirut, Lebanon, 2334
        • Recruiting
        • Physical therapy outpatient clinic
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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
Experimental: interventional group
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.
The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises
Other Names:
  • Forward head correction
Sham Comparator: conrol group
General exercises
The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises
Other Names:
  • Forward head correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMG activity
Time Frame: 10 weeks
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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of TMJ range of motion.
Time Frame: 10 weeks
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.
10 weeks
Fonseca's questionnaire
Time Frame: 10 weeks
assess the prevalence and severity of temporomandibular disorders.
10 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: Ahmed ElMelhat, Professor, Assistant Prof of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 7, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

August 29, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

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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