Head PainNCT05712655
Masticatory Muscles Electromyography in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders
An observational study of Head Pain and TMJ Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate masticatory muscle electrical activity in post-pubertal females with forward head posture (FHP) and temporomandibular disorders (TMD) as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders. Read more about this study
- Who is it for?
- Ages 17 to 22 years, women only
- Conditions the study is for
- Head Pain, TMJ Disorder
- What is being tested?
- Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 28 Feb 2022
- Phase
- Observational
- 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 17 to 22 years
- Women only
- Child, Adult
Study population: They were invited to participate in the study through flyers and social media invitations
Who may be able to join
- Age ranging from 17 to 22 years.
- Body mass index ranging from 18 to 25 kg/m2.
- Having a normal menstrual cycle.
- Spending four to six hours per day with bad posture on computer, laptop or smart phones.
- Fully dentate subjects.
Who cannot join
- Having dental loss, acquired dental anomalies, current use of dental prostheses, malocclusion, sleep bruxism.
- Having inflammatory diseases of the face or jaw, fibromyalgia, or any fractures or surgeries in the orofacial or neck areas.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyographic Activity of Masticatory Muscles in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders: An Observational Trial
The aim of this study was to evaluate masticatory muscle electrical activity in post-pubertal females with forward head posture (FHP) and temporomandibular disorders (TMD) as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.
Read the detailed description
It has been demonstrated by a previous study that a strong relationship exists between forward head posture and temporomandibular disorders and that individuals with forward head posture and temporomandibular disorders exhibit alterations in masticatory muscle electromyographic activity either as a result of the disorder itself or due to a compensatory mechanism associated with the symptoms of temporomandibular disorders . As a consequence, the aim of the study was to evaluate the electromyographic activity of the masticatory muscles in post-pubertal females with forward head posture and temporomandibular disorders as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.
- Conditions
- Head Pain, TMJ Disorder
- Being tested
- Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.
- Keywords
- Forward head posture, Temporomandibular disorders, Masticatory muscles, Electromyography, post-pubertal females
- Medical subject headings
- Headache, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.Other
Assessment was done by surface electromyography (sEMG) device.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Post-pubertal females with forward head posture and temporomandibular disorders Receives: Other: Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles. | |
| Control group | Post-pubertal females with neutral head posture and with no temporomandibular disorders Receives: Other: Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic (EMG) activity of masticatory muscles
Measurement of bilateral EMG activity of Masseter and Anterior Temporalis muscles
Measured: 8 months
Secondary outcomes (2)
Measurement of cranivertebral angle (CVA)
Photographic assessment of cranivertebral angle.
Measured: 8 months
Assessment of research Diagnostic criteria for temporomandibular Disorders (RDC/TMDS)
Temporomandibular disorders were assessed through the research Diagnostic criteria for temporomandibular Disorders (RDC/TMDS).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jul 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Amel M Yousef, Professor, Principal investigator, Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712655
- Sponsor's protocol ID
- P.T.REC/012/002660
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Activity of Masticatory Muscles in Post-pubertal Females With Forward Head Posture and Temporomandibular Disorders: An Observational Trial
- ClinicalTrials.gov ID
- NCT05712655
- Acronym / sponsor ID
- P.T.REC/012/002660
- Conditions
- Head Pain, TMJ Disorder
- Keywords
- Forward head posture, Temporomandibular disorders, Masticatory muscles, Electromyography, post-pubertal females
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 3 Feb 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.
The aim of this study was to evaluate masticatory muscle electrical activity in post-pubertal females with forward head posture (FHP) and temporomandibular disorders (TMD) as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.
Detailed description
It has been demonstrated by a previous study that a strong relationship exists between forward head posture and temporomandibular disorders and that individuals with forward head posture and temporomandibular disorders exhibit alterations in masticatory muscle electromyographic activity either as a result of the disorder itself or due to a compensatory mechanism associated with the symptoms of temporomandibular disorders . As a consequence, the aim of the study was to evaluate the electromyographic activity of the masticatory muscles in post-pubertal females with forward head posture and temporomandibular disorders as well as in post-pubertal females with neutral head posture and with no temporomandibular disorders.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.Post-pubertal females with forward head posture and temporomandibular disorders |
| Control group | – | Other: Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.Post-pubertal females with neutral head posture and with no temporomandibular disorders |
Who may qualify
- Ages
- 17 to 22 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- They were invited to participate in the study through flyers and social media invitations
Key inclusion criteria (5 listed)
- Age ranging from 17 to 22 years.
- Body mass index ranging from 18 to 25 kg/m2.
- Having a normal menstrual cycle.
- Spending four to six hours per day with bad posture on computer, laptop or smart phones.
- Fully dentate subjects.
Key exclusion criteria (2 listed)
- Having dental loss, acquired dental anomalies, current use of dental prostheses, malocclusion, sleep bruxism.
- Having inflammatory diseases of the face or jaw, fibromyalgia, or any fractures or surgeries in the orofacial or neck areas.
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 |
|---|---|---|
| Measurement of bilateral electromyographic activity of Masseter and Anterior Temporalis muscles.Assessment was done by surface electromyography (sEMG) device. | Other | Control group, Study group |
Primary outcome
Electromyographic (EMG) activity of masticatory muscles
Time frame: 8 months
Measurement of bilateral EMG activity of Masseter and Anterior Temporalis muscles
2 secondary outcomes
Measurement of cranivertebral angle (CVA)
Time frame: 8 months
Assessment of research Diagnostic criteria for temporomandibular Disorders (RDC/TMDS)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Amel M Yousef, Professor principal investigator
Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Pain and TMJ Disorder, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 8 Feb 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic (EMG) activity of masticatory muscles (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.