Temporomandibular DisorderNCT05756010
Effect of Forward Head Correction on EMG of Masticatory Muscles in Patients With TMD
A study testing EMG in people with Temporomandibular Disorder, run by Beirut Arab University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- EMG
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 7 Jun 2023to 29 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Physical therapy outpatient clinic
Beirut, 2334
Ahmed ElMelhat, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: 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.
Read the 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.
- 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..
- Conditions
- Temporomandibular Disorder
- Being tested
- EMG
- Keywords
- TMJ pain, EMG activity, cervical pain
- Medical subject headings
- Temporomandibular Joint Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGDevice
Also called Forward head correction
The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | 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. Receives: Device: EMG |
| conrol group | Sham comparator | General exercises Receives: Device: EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (2)
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.
Measured: 10 weeks
Fonseca's questionnaire
assess the prevalence and severity of temporomandibular disorders.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start7 Jun 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion29 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Abbas, Beirut Arab University
- Investigators
- Ahmed ElMelhat, Professor, Study chair, Assistant Prof of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756010
- Sponsor's protocol ID
- Tempromandibular disorder TMD
- Status last verified
- Jun 2023
- First submitted
- 23 Feb 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30584494Ballenberger 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.
PubMed 22632591Wang 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.
PubMed 19291503Yao 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.
PubMed 36241923Xu 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.
PubMed 33691457Berni 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.
PubMed 26054969Tecco 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.
PubMed 18990679Chaves 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.
PubMed 28483248Cuenca-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.
PubMed 32872670
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Forward Head Correction on EMG Activity of Masticatory and Cervical Muscles in Patients With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT05756010
- Acronym / sponsor ID
- Tempromandibular disorder TMD
- Conditions
- Temporomandibular Disorder
- Keywords
- TMJ pain, EMG activity, cervical pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 29 Aug 2023 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Device: EMGThe 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. |
| conrol group | Sham comparator | Device: EMGGeneral exercises |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMGAlso: Forward head correctionThe program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises | Device | conrol group, interventional group |
Primary outcome
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.
2 secondary outcomes
Measurement of TMJ range of motion.
Time frame: 10 weeks
Fonseca's questionnaire
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 30584494Kim 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.
- Background: PubMed 22632591Ballenberger 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.
- Background: PubMed 19291503Wang 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.
- Background: PubMed 36241923Yao 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.
- Background: PubMed 33691457Xu 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.
- Background: PubMed 26054969Berni 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.
- Background: PubMed 18990679Tecco 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.
- Background: PubMed 28483248Chaves 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.
- Background: PubMed 32872670Cuenca-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed ElMelhat, Professor study chair
Assistant Prof of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG in people with Temporomandibular Disorder, run by Beirut Arab University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lama bassem jarjour, DPT (70015158, jarjourlama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG activity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756010, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.