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Temporomandibular Joint Dysfunction SyndromeNCT05966103

Efficacy of Scapulothoracic Exercises on Postural Stability, Proprioception, Muscular Features and Mandibular Functions

A study testing Exercises in people with Temporomandibular Joint Dysfunction Syndrome and Forward Head Posture, run by Cyprus International University at 1 site in Turkey (Türkiye).

Completed

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

Official record
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Trial summary

The goal of this Randomized, Double-Blind, Clinical Trial is to investigate the effects of scapulothoracic exercises on postural stability, muscle strength, muscular endurance, mandibular functions and proprioception in sedentary individuals aged 18-45 years with head forward posture and temporomandibular joint… Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Dec 2022to 5 Jul 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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female students and employees between the ages of 18-45,
  • Individuals with a craniovertabral angle (CVA) <50° and a Fonseca questionnaire score between 20-100,
  • Individuals with a Helkimo clinical dysfunction index score between 1-25,
  • Individuals with a low level of physical activity according to the International Physical Activity Questionnaire.

Who cannot join

  • Serious problems of the musculoskeletal system, including the cervical and thoracic spine,
  • Presence of serious chronic diseases such as hypertension, diabetes, cancer,
  • Presence of neurological disease at a level that will affect balance and postural control,
  • Being pregnant,
  • Tooth and jaw problems in the last 6 months,
  • Individuals with a total denture or prosthesis on the anterior teeth.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Cyprus International University

    Mersin, Lefkosa, 99040

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Scapulothoracic Exercises on Postural Stability, Muscle Strength, Muscular Endurance and Proprioception in Sedentary Individuals With Cranio-Servico-Mandibular Malalignment

The goal of this Randomized, Double-Blind, Clinical Trial is to investigate the effects of scapulothoracic exercises on postural stability, muscle strength, muscular endurance, mandibular functions and proprioception in sedentary individuals aged 18-45 years with head forward posture and temporomandibular joint dysfunction (Cranio-Cervico-Mandibular Malalignment). The main questions it aims to answer are:

  • Do Scapulothoracic exercises given in addition to cervical posture exercises have an effect on postural stability, proprioception, muscle strength, muscular endurance and mandibular functions in individuals with Cranio-Cervico-Mandibular malalignment?

Researchers will compare conventional neck exercises (control group) and scapulothoracic exercises applied in addition to conventional neck exercises (treatment group) to see the effects of scapulothoracic exercises on the neck and jaw area.

Read the detailed description

The investigators aimed to investigate the effects of scapulothoracic exercises on postural stability, muscle strength, muscular endurance, mandibular functions and proprioception in sedentary individuals aged 18-45 years with cranio-cervico-mandibular malalignment including head-first posture and temporomandibular joint dysfunction problems.

Being tested
Exercises
Keywords
Musculoskeletal Rehabilitation, Temporomandibular Joint Treatment, Scapulothoracic Exercises, Cranio-Cervico-Mandibular Malalignment
Medical subject headings
Temporomandibular Joint Dysfunction Syndrome

What participants receive

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

  • ExercisesOther

    For control group; Cervical conventional exercises. For treatment group; scapulothoracic exercises including strengthening, proprioceptive and stabilization exercises in addition to cervical conventional exercises

Study groups in NCT05966103
Study groupRoleWhat they receive
Conventional Exercise Group (Control Group)Active comparatorConventional neck exercises were applied to the control group.
Receives: Other: Exercises
Scapulothoracic Exercise (Treatment Group)ExperimentalIn the treatment group, scapulothoracic exercises were applied in addition to conventional neck exercises.
Receives: Other: Exercises

What is being measured

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

  1. Postural Stability

    Five different data were obtained: the peripheral length value of the total sway degree (°) made on the device during balance, the percentile value of the area gap (%) showing the percentage of the area drawn according to the reference circle, the sway velocity value (°/sec), the average values (°) reached in the sway in the antero-posterior (AP) and medio-lateral (ML) directions.

    Measured: Postural stability was measured at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The average measurement time for each participant was 5 min.

  2. Joint Position Sense

    Mandibular and cervical joint position sense measurements were made.

    Measured: Proprioception measurements were made at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The mean measurement time for mandibular position sense for each participant was 8 min. Cervical joint position sense measure

Secondary outcomes (3)

  1. Muscle Strength

    Isometric muscle strength test will be performed on TMJ depressor muscles and cervical region muscles.

    Measured: Muscle strength measurements were made at 3 different times (pre-treatment, 8th week post-treatment, 12th-week follow-up). The temporomandibular joint depressor muscle strength measurement time for each participant lasted 3 minutes. The st

  2. Endurance Measurement of Deep Neck Flexor Muscles

    The muscular endurance measurement of the deep neck flexors will be made using the "craniocervical flexion test" and a stabilizer device.

    Measured: Muscular endurance of deep neck flexors was measured at 3 different times (pre-treatment, 8th week post-treatment, 12th week post-treatment follow-up). It took an average of 15 minutes for each participant.

  3. Mandibular Function Disorder Questionnaire (MFBA)

    It is used to evaluate the level of impairment in jaw functions in patients with TMED.

    Measured: Mandibular Function Disorder Questionnaire (MFBA) was measured at 3 different times (pre-treatment, 8th week post-treatment, 12th week post-treatment follow-up). It took an average of 2 minutes for each participant.

Timeline

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

  1. First posted28 Jul 2023
  2. Study start5 Dec 2022
  3. Primary completion10 Apr 2023
  4. Study completion5 Jul 2023

Resources

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
Model description
Randomized Comparative Double-Blind Study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05966103
Sponsor's protocol ID
2022-0232
Status last verified
Jul 2023
First submitted
21 Jul 2023
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sajjadi, E., Olyaei, G. R., Talebian, S., Hadian, M. R., & Jalaie, S. (2014). The effect of forward head posture on cervical joint position sense. Archives of Advances in Biosciences, 5(4).

  • Ryan, J., Akhter, R., Hassan, N., Hilton, G., Wickham, J., & Ibaragi, S. (2019). Epidemiology of temporomandibular disorder in the general population: A systematic review. Adv Dent Oral Health, 10(3), 1-13.

  • Weber, P., Corrêa, E. C. R., de Paula Bolzan, G., dos Santos Ferreira, F., Soares, J. C., & da Silva, A. M. T. (2012). Relationship between craniocervical posture, mandible and hyoid bone and influence on alimentary functions. Brazilian Journal of Oral Sciences, 11(2), 141-147.

  • Ries LG, Berzin F. Analysis of the postural stability in individuals with or without signs and symptoms of temporomandibular disorder. Braz Oral Res. 2008 Oct-Dec;22(4):378-83. doi: 10.1590/s1806-83242008000400016.

    PubMed 19148396

  • Gadotti I, Hicks K, Koscs E, Lynn B, Estrazulas J, Civitella F. Electromyography of the masticatory muscles during chewing in different head and neck postures - A pilot study. J Oral Biol Craniofac Res. 2020 Apr-Jun;10(2):23-27. doi: 10.1016/j.jobcr.2020.02.002. Epub 2020 Feb 5.

    PubMed 32071851

  • Moustafa IM, Youssef A, Ahbouch A, Tamim M, Harrison DE. Is forward head posture relevant to autonomic nervous system function and cervical sensorimotor control? Cross sectional study. Gait Posture. 2020 Mar;77:29-35. doi: 10.1016/j.gaitpost.2020.01.004. Epub 2020 Jan 7.

    PubMed 31955048

  • de Albuquerque Vieira, M., de Araújo, M. D. G. R., Antonino, G. B., da Silva Tenório, A., das Graças Paiva, M., & de Lima Ferreira, A. P. (2018). Cervical and scapular instability in subjects with temporomandibular disorder. Manual Therapy, Posturology & Rehabilitation Journal, 1-5.

  • Chaves TC, Turci AM, Pinheiro CF, Sousa LM, Grossi DB. Static body postural misalignment in individuals with temporomandibular disorders: a systematic review. Braz J Phys Ther. 2014 Nov-Dec;18(6):481-501. doi: 10.1590/bjpt-rbf.2014.0061. Epub 2014 Oct 31.

    PubMed 25590441

  • Safwat͘, Y. M., Wadee, A. N., Lasheen, Y. R., & Kamel, R. M. (2019). Influence of Scapular Stabilization Exercises on Asymptomatic Forward Head Posture; A Randomized Controlled Trial. Indian Journal of Public Health Research & Development, 10(12).

  • Dickerson SM, Weaver JM, Boyson AN, Thacker JA, Junak AA, Ritzline PD, Donaldson MB. The effectiveness of exercise therapy for temporomandibular dysfunction: a systematic review and meta-analysis. Clin Rehabil. 2017 Aug;31(8):1039-1048. doi: 10.1177/0269215516672275. Epub 2016 Oct 3.

    PubMed 27697824

  • Saito ET, Akashi PM, Sacco Ide C. Global body posture evaluation in patients with temporomandibular joint disorder. Clinics (Sao Paulo). 2009;64(1):35-9. doi: 10.1590/s1807-59322009000100007.

    PubMed 19142549

  • Zhao W, You H, Jiang S, Zhang H, Yang Y, Zhang M. Effect of Pro-kin visual feedback balance training system on gait stability in patients with cerebral small vessel disease. Medicine (Baltimore). 2019 Feb;98(7):e14503. doi: 10.1097/MD.0000000000014503.

    PubMed 30762779

Questions about this trial

What is this clinical trial studying?

A study testing Exercises in people with Temporomandibular Joint Dysfunction Syndrome and Forward Head Posture, run by Cyprus International University at 1 site in Turkey (Türkiye).

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 4 inclusion and 6 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 2 Aug 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 Turkey (Türkiye). 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?

Postural Stability (time frame: Postural stability was measured at 3 different times (before treatment, 8 weeks after treatment, 12 weeks follow up). The average measurement time for each participant was 5 min.). The study lists 2 primary outcomes in all. 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 NCT05966103, which also lists 12 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 2 Aug 2023.

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