NCT05966103

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 21, 2023

Last Update Submit

July 31, 2023

Conditions

Keywords

Musculoskeletal RehabilitationTemporomandibular Joint TreatmentScapulothoracic ExercisesCranio-Cervico-Mandibular Malalignment

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

  • Joint Position Sense

    Mandibular and cervical joint position sense measurements were made.

    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)

  • Muscle Strength

    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

  • Endurance Measurement of Deep Neck Flexor Muscles

    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.

  • Mandibular Function Disorder Questionnaire (MFBA)

    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.

Other Outcomes (1)

  • Body Mass Index

    Body Mass Index was measured at pre-treatment period.

Study Arms (2)

Conventional Exercise Group (Control Group)

ACTIVE COMPARATOR

Conventional neck exercises were applied to the control group.

Other: Exercises

Scapulothoracic Exercise (Treatment Group)

EXPERIMENTAL

In the treatment group, scapulothoracic exercises were applied in addition to conventional neck exercises.

Other: Exercises

Interventions

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

Conventional Exercise Group (Control Group)Scapulothoracic Exercise (Treatment Group)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cyprus International University

Mersin, Lefkosa, 99040, Turkey (Türkiye)

Location

Related Publications (12)

  • 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).

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 19148396BACKGROUND
  • 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.

    PMID: 32071851BACKGROUND
  • 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.

    PMID: 31955048BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25590441BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 27697824BACKGROUND
  • 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.

    PMID: 19142549BACKGROUND
  • 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.

    PMID: 30762779BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mehmet Micoogullari, MSc

    Cyprus International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Evaluations were done by a different physical therapist. The physiotherapist who administered the treatment was different. In addition, the participants did not know which group they were in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Comparative Double-Blind Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2023

First Posted

July 28, 2023

Study Start

December 5, 2022

Primary Completion

April 10, 2023

Study Completion

July 5, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations