Temporomandibular DisorderNCT06065826

Forward Head Posture and Myogenic TMD Association in Smartphone Overuse

An observational study of Temporomandibular Disorder, run by Doha Hany Mohamed Labib at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this observational study is to determine the correlation between forward head posture and myogenic temporomandibular disorder, pain pressure threshold and endurance of masticatory and neck muscles in addicted smart phone users. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Temporomandibular Disorder
What is being tested?: Assessment
How many people: 46 participants
Where: 1 siteEgypt
Study dates: 17 Oct 2023to 15 Dec 2023
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Study population: 23 subjects with myogenic TMD, FHP and addicted to smartphone devices will be assessed for pressure pain threshold on trigger points and muscle endurance in both masticatory and neck muscles

Who may be able to join

Subject's age range from 18 - 40 years.
Both males and females will be recruited.
Subjects diagnosed as myogenic TMD according to the presence of trigger points in masseter, temporalis, upper trapezius and C5-C6 articular pillars according to the myofascial diagnostic criteria that includes a taut band and hypersensitive spot
All subjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33.
All subjects will have forward head posture assessed by CVA less than 49.9 degrees.

Who cannot join

History of head, neck or TMJ trauma
Patients who underwent orthodontic treatment
Congenital, or acquired postural deformity
No previous neck or spinal or TMJ surgery
Subjects who are on anti-inflammatory or analgesic drugs for pain

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Chinese Egyptian University
Cairo

Other trials in Egypt

About this study

Official title: Correlation Between Forward Head Posture And Myogenic Temporomandibular Disorder In Addicted Smartphone Users

What is the correlation between forward head posture and myogenic temporomandibular disorder, pain pressure threshold and endurance of masticatory and neck muscles in addicted smart phone users?

Read the detailed description

Temporomandibular joint (TMJ) and cervical spine are closely related to each other due to their anatomical, mechanical and neurophysiological relationships. That's why pain and dysfunction in the cervical spine can be observed in patients with temporomandibular disorders (TMD) who may suffer from clinical problems in the masticatory muscles, the temporomandibular joint and other associated structures.

Millions of people worldwide use their smartphone devices excessively. Prevalence of smartphone addiction among Egyptian university students was 62.4% revealing that females had a higher addiction than men. This excessive use where subjects downwardly flex their neck to enable them to look at the screen, affects head and neck postures leading to forward head posture (FHP) which consequently alters the position of the mandible along with its functions, resulting in an increase tension in the masticatory muscles causing TMD. Addicted smartphone users contribute to changes in craniocervical region which led to myogenic TMD in young teenagers.

Pain, tenderness in masticatory muscles and cervical muscle endurance are common clinical findings in patients with TMD; where muscle tenderness is reduced and cervical muscle endurance was found to have a shorter duration holding time when performing neck extensor endurance test due to higher fatigability of neck extensor muscles.

Conditions: Temporomandibular Disorder
Being tested: Assessment
Keywords: forward head posture, smartphone
Medical subject headings: Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AssessmentOther
All subjects will be assessed for FHP by taking a lateral view picture to calculate the CVA using the Kinovea software. Each subject with FHP will be examined for myofascial trigger points done by the therapist finger to palpate bilaterally on tender nodules in masticatory and neck muscles. Then using a pressure algometer, the PPT value will be scored for each trigger in each muscle bilaterally. Masticatory muscle endurance will be measured by asking the subject to bite on load sensor for as long as the subject can until exhaustion. Using a stopwatch, the time will be recorded in seconds. Using the craniocervical extension endurance test, the subject will lie prone with their head unsupported and with a bubble inclinometer attached to their head. Using a stopwatch, time in seconds will be recorded to test how long the subject can sustain the neck in neutral position. Finally, a smartphone addiction scale will be answered by the subject to identify how much they are addicted to its use.

Study groups in NCT06065826
Study group	Role	What they receive
subjects with myogenic TMD		Subjects diagnosed as myogenic TMD according to the presence of trigger points in masseter, temporalis, upper trapezius and C5-C6 articular pillars Subjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33. Subjects have forward head posture assessed by CVA <49.9 degrees Receives: Other: Assessment
subjects without myogenic TMD		Subjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33. Subjects have forward head posture assessed by CVA <49.9 degrees Receives: Other: Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

pressure pain threshold
For the masticatory muscles, the subject will be sitting and the therapist will place the pressure algometer on the belly of the masseter and temporalis muscles. A gradual pressure will be applied until the subject experiences pain. The value displayed on the device will be recorded. This will be repeated 3 times on each side. For the upper trapezius muscles, subject will be seated. Using the algometer, a pressure will be applied on midpoint of the trapezius. Then subject will lie prone, to apply pressure by the algometer on a point 1 cm laterally to the midpoint between C6 and C5 spinous processes. A value will be recorded when subject feels pain. This will be repeated 3 times on each side.
Measured: 5 mintues

Secondary outcomes (2)

muscle endurance
To assess masticatory muscles, subject will sit in an upright position and will bite on the first molar at maximum voluntary contraction until exhaustion on an I load mini bite load cell. Using a stopwatch, time in seconds will be recorded for both sides. long maintenance time means good endurance.Test will be terminated when any pain or discomfort is felt in the masticatory muscles.Craniocervical extension endurance test will assess neck extensors endurance. Subject will lie prone on a plinth with the head and neck unsupported and a bubble inclinometer will be fixed on the head using a strap. Subject will be asked to sustain a neutral position for as long as possible and time in seconds will be recorded. The test will be terminated if pain is felt in the neck or if the head failed to maintain its neutral position or if it moved more than 5 degrees shown by inclinometer.
Measured: 10 minutes
smartphone addiction scale short version
Smartphone addiction scale - short version (SAS-SV) is a screening tool to identify individuals that are dependent on smartphone use. Maximum score is 60 and the minimum is 10. The cut off value of smartphone addiction use differ by gender, in males it is 31 and in females it is 33. higher score means patient were addicted on the smartphones.
Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 202315 Dec 2023

First posted4 Oct 2023
Study start17 Oct 2023
Primary completion17 Nov 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)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: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06065826
Sponsor's protocol ID: FHP and MTMD in SMP
Status last verified: Feb 2024
First submitted: 29 Aug 2023
Last updated: 20 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Resende CM, Alves AC, Coelho LT, Alchieri JC, Roncalli AG, Barbosa GA. Quality of life and general health in patients with temporomandibular disorders. Braz Oral Res. 2013 Mar-Apr;27(2):116-21. doi: 10.1590/s1806-83242013005000006. Epub 2013 Mar 1.
PubMed 23459771
Rashed, S. A., & Elsharkawy, A. T. (2018). Prevalence and severity of Temporomandibular disorders signs and symptoms Among Students of The Ahram Canadian University (ACU). Egyptian Dental Journal, 64(3-July (Oral Surgery), 2097-2104
Soliman Elserty, N., Ahmed Helmy, N., & Mohmed Mounir, K. (2020). Smartphone addiction and its relation to musculoskeletal pain in Egyptian physical therapy students. European Journal of Physiotherapy, 22(2), 70-78
Kee IK, Byun JS, Jung JK, Choi JK. The presence of altered craniocervical posture and mobility in smartphone-addicted teenagers with temporomandibular disorders. J Phys Ther Sci. 2016 Jan;28(2):339-46. doi: 10.1589/jpts.28.339. Epub 2016 Feb 29.
PubMed 27065516
Berolo S, Wells RP, Amick BC 3rd. Musculoskeletal symptoms among mobile hand-held device users and their relationship to device use: A preliminary study in a Canadian university population. Appl Ergon. 2011 Jan;42(2):371-8. doi: 10.1016/j.apergo.2010.08.010. Epub 2010 Sep 15.
PubMed 20833387
Mani, M. S., Ahamed, S. Y., Kavithagiri, N. L., Ambiga, P., Sivaraman, G., & Balan, N. (2019). Association of Mobile Phone Usage in Patients with Temporomandibular Joint Disorders-A Comparative Study. Journal homepage: www. nacd. in Indian J Dent Adv, 11(3), 79-85.
Park, J., Kim, K., Kim, N., Choi, I., Lee, S., Tak, S., & Yim, J. (2015)b. A comparison of cervical flexion, pain, and clinical depression in frequency of smartphone use. International Journal of Bio-Science and Bio-Technology, 7(3), 183-90
Torkamani MH, Mokhtarinia HR, Vahedi M, Gabel CP. Relationships between cervical sagittal posture, muscle endurance, joint position sense, range of motion and level of smartphone addiction. BMC Musculoskelet Disord. 2023 Jan 23;24(1):61. doi: 10.1186/s12891-023-06168-5.
PubMed 36690958
Vargas CM, Kramarow EA, Yellowitz JA. The oral health of older Americans. Aging Trends. 2001 Mar;(3):1-8. No abstract available.
PubMed 11894225
Hugo FN, Hilgert JB, de Sousa Mda L, da Silva DD, Pucca GA Jr. Correlates of partial tooth loss and edentulism in the Brazilian elderly. Community Dent Oral Epidemiol. 2007 Jun;35(3):224-32. doi: 10.1111/j.0301-5661.2007.00346.x.
PubMed 17518969
Svensson P, Macaluso GM, De Laat A, Wang K. Effects of local and remote muscle pain on human jaw reflexes evoked by fast stretches at different clenching levels. Exp Brain Res. 2001 Aug;139(4):495-502. doi: 10.1007/s002210100806.
PubMed 11534874
Martinez-Merinero P, Nunez-Nagy S, Achalandabaso-Ochoa A, Fernandez-Matias R, Pecos-Martin D, Gallego-Izquierdo T. Relationship between Forward Head Posture and Tissue Mechanosensitivity: A Cross-Sectional Study. J Clin Med. 2020 Feb 27;9(3):634. doi: 10.3390/jcm9030634.
PubMed 32120895
Griegel-Morris P, Larson K, Mueller-Klaus K, Oatis CA. Incidence of common postural abnormalities in the cervical, shoulder, and thoracic regions and their association with pain in two age groups of healthy subjects. Phys Ther. 1992 Jun;72(6):425-31. doi: 10.1093/ptj/72.6.425.
PubMed 1589462
Diab AA, Moustafa IM. The efficacy of forward head correction on nerve root function and pain in cervical spondylotic radiculopathy: a randomized trial. Clin Rehabil. 2012 Apr;26(4):351-61. doi: 10.1177/0269215511419536. Epub 2011 Sep 21.
PubMed 21937526
Yao Y, Cai B, Xu LL, Wang JW. [Correlation between neck pressure pain threshold and forward head posture in patients with temporomandibular joint disorders]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2021 Aug 9;56(8):759-763. doi: 10.3760/cma.j.cn112144-20210312-00111. Chinese.
PubMed 34404141

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Temporomandibular Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation Between Forward Head Posture And Myogenic Temporomandibular Disorder In Addicted Smartphone Users
ClinicalTrials.gov ID: NCT06065826
Acronym / sponsor ID: FHP and MTMD in SMP
Conditions: Temporomandibular Disorder
Keywords: forward head posture, smartphone
Study type: Observational
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Doha Hany Mohamed LabibUniversity, hospital or other
Study start: 17 Oct 2023 (actual)
Primary completion: 17 Nov 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 4 Oct 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.

What is the correlation between forward head posture and myogenic temporomandibular disorder, pain pressure threshold and endurance of masticatory and neck muscles in addicted smart phone users?

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
subjects with myogenic TMD	–	Other: AssessmentSubjects diagnosed as myogenic TMD according to the presence of trigger points in masseter, temporalis, upper trapezius and C5-C6 articular pillars Subjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33. Subjects have forward head posture assessed by CVA <49.9 degrees
subjects without myogenic TMD	–	Other: AssessmentSubjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33. Subjects have forward head posture assessed by CVA <49.9 degrees

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: 23 subjects with myogenic TMD, FHP and addicted to smartphone devices will be assessed for pressure pain threshold on trigger points and muscle endurance in both masticatory and neck muscles

Key inclusion criteria (5 listed)

Subject's age range from 18 - 40 years.
Both males and females will be recruited.
Subjects diagnosed as myogenic TMD according to the presence of trigger points in masseter, temporalis, upper trapezius and C5-C6 articular pillars according to the myofascial diagnostic criteria that includes a taut band and hypersensitive spot
All subjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33.
All subjects will have forward head posture assessed by CVA less than 49.9 degrees.

Key exclusion criteria (5 listed)

History of head, neck or TMJ trauma
Patients who underwent orthodontic treatment
Congenital, or acquired postural deformity
No previous neck or spinal or TMJ surgery
Subjects who are on anti-inflammatory or analgesic drugs for pain

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
AssessmentAll subjects will be assessed for FHP by taking a lateral view picture to calculate the CVA using the Kinovea software. Each subject with FHP will be examined for myofascial trigger points done by the therapist finger to palpate bilaterally on tender nodules in masticatory and neck muscles. Then using a pressure algometer, the PPT value will be scored for each trigger in each muscle bilaterally. Masticatory muscle endurance will be measured by asking the subject to bite on load sensor for as long as the subject can until exhaustion. Using a stopwatch, the time will be recorded in seconds. Using the craniocervical extension endurance test, the subject will lie prone with their head unsupported and with a bubble inclinometer attached to their head. Using a stopwatch, time in seconds will be recorded to test how long the subject can sustain the neck in neutral position. Finally, a smartphone addiction scale will be answered by the subject to identify how much they are addicted to its use.	Other	subjects with myogenic TMD, subjects without myogenic TMD

Primary outcome

pressure pain threshold
Time frame: 5 mintues
For the masticatory muscles, the subject will be sitting and the therapist will place the pressure algometer on the belly of the masseter and temporalis muscles. A gradual pressure will be applied until the subject experiences pain. The value displayed on the device will be recorded. This will be repeated 3 times on each side. For the upper trapezius muscles, subject will be seated. Using the algometer, a pressure will be applied on midpoint of the trapezius. Then subject will lie prone, to apply pressure by the algometer on a point 1 cm laterally to the midpoint between C6 and C5 spinous processes. A value will be recorded when subject feels pain. This will be repeated 3 times on each side.

2 secondary outcomes

muscle endurance
Time frame: 10 minutes
smartphone addiction scale short version
Time frame: 2 minutes

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 20 Feb 2024.
Background: PubMed 23459771Resende CM, Alves AC, Coelho LT, Alchieri JC, Roncalli AG, Barbosa GA. Quality of life and general health in patients with temporomandibular disorders. Braz Oral Res. 2013 Mar-Apr;27(2):116-21. doi: 10.1590/s1806-83242013005000006. Epub 2013 Mar 1.
BackgroundRashed, S. A., & Elsharkawy, A. T. (2018). Prevalence and severity of Temporomandibular disorders signs and symptoms Among Students of The Ahram Canadian University (ACU). Egyptian Dental Journal, 64(3-July (Oral Surgery), 2097-2104
BackgroundSoliman Elserty, N., Ahmed Helmy, N., & Mohmed Mounir, K. (2020). Smartphone addiction and its relation to musculoskeletal pain in Egyptian physical therapy students. European Journal of Physiotherapy, 22(2), 70-78
Background: PubMed 27065516Kee IK, Byun JS, Jung JK, Choi JK. The presence of altered craniocervical posture and mobility in smartphone-addicted teenagers with temporomandibular disorders. J Phys Ther Sci. 2016 Jan;28(2):339-46. doi: 10.1589/jpts.28.339. Epub 2016 Feb 29.
Background: PubMed 20833387Berolo S, Wells RP, Amick BC 3rd. Musculoskeletal symptoms among mobile hand-held device users and their relationship to device use: A preliminary study in a Canadian university population. Appl Ergon. 2011 Jan;42(2):371-8. doi: 10.1016/j.apergo.2010.08.010. Epub 2010 Sep 15.
BackgroundMani, M. S., Ahamed, S. Y., Kavithagiri, N. L., Ambiga, P., Sivaraman, G., & Balan, N. (2019). Association of Mobile Phone Usage in Patients with Temporomandibular Joint Disorders-A Comparative Study. Journal homepage: www. nacd. in Indian J Dent Adv, 11(3), 79-85.
BackgroundPark, J., Kim, K., Kim, N., Choi, I., Lee, S., Tak, S., & Yim, J. (2015)b. A comparison of cervical flexion, pain, and clinical depression in frequency of smartphone use. International Journal of Bio-Science and Bio-Technology, 7(3), 183-90
Background: PubMed 36690958Torkamani MH, Mokhtarinia HR, Vahedi M, Gabel CP. Relationships between cervical sagittal posture, muscle endurance, joint position sense, range of motion and level of smartphone addiction. BMC Musculoskelet Disord. 2023 Jan 23;24(1):61. doi: 10.1186/s12891-023-06168-5.
Background: PubMed 11894225Vargas CM, Kramarow EA, Yellowitz JA. The oral health of older Americans. Aging Trends. 2001 Mar;(3):1-8. No abstract available.
Background: PubMed 17518969Hugo FN, Hilgert JB, de Sousa Mda L, da Silva DD, Pucca GA Jr. Correlates of partial tooth loss and edentulism in the Brazilian elderly. Community Dent Oral Epidemiol. 2007 Jun;35(3):224-32. doi: 10.1111/j.0301-5661.2007.00346.x.
Background: PubMed 11534874Svensson P, Macaluso GM, De Laat A, Wang K. Effects of local and remote muscle pain on human jaw reflexes evoked by fast stretches at different clenching levels. Exp Brain Res. 2001 Aug;139(4):495-502. doi: 10.1007/s002210100806.
Background: PubMed 32120895Martinez-Merinero P, Nunez-Nagy S, Achalandabaso-Ochoa A, Fernandez-Matias R, Pecos-Martin D, Gallego-Izquierdo T. Relationship between Forward Head Posture and Tissue Mechanosensitivity: A Cross-Sectional Study. J Clin Med. 2020 Feb 27;9(3):634. doi: 10.3390/jcm9030634.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Temporomandibular Disorder, run by Doha Hany Mohamed Labib 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 5 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 20 Feb 2024. 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?

pressure pain threshold (time frame: 5 mintues). 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 NCT06065826, which also lists 15 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 20 Feb 2024.