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

Primary Purpose

Temporomandibular Joint Dysfunction Syndrome, Forward Head Posture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises
Sponsored by
Cyprus International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring Musculoskeletal Rehabilitation, Temporomandibular Joint Treatment, Scapulothoracic Exercises, Cranio-Cervico-Mandibular Malalignment

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Cyprus International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Exercise Group (Control Group)

Scapulothoracic Exercise (Treatment Group)

Arm Description

Conventional neck exercises were applied to the control group.

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

Outcomes

Primary Outcome Measures

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.
Joint Position Sense
Mandibular and cervical joint position sense measurements were made.

Secondary Outcome Measures

Muscle Strength
Isometric muscle strength test will be performed on TMJ depressor muscles and cervical region muscles.
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.
Mandibular Function Disorder Questionnaire (MFBA)
It is used to evaluate the level of impairment in jaw functions in patients with TMED.

Full Information

First Posted
July 21, 2023
Last Updated
July 31, 2023
Sponsor
Cyprus International University
Collaborators
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05966103
Brief Title
Efficacy of Scapulothoracic Exercises on Postural Stability, Proprioception, Muscular Features and Mandibular Functions
Official Title
The Effects of Scapulothoracic Exercises on Postural Stability, Muscle Strength, Muscular Endurance and Proprioception in Sedentary Individuals With Cranio-Servico-Mandibular Malalignment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyprus International University
Collaborators
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome, Forward Head Posture
Keywords
Musculoskeletal Rehabilitation, Temporomandibular Joint Treatment, Scapulothoracic Exercises, Cranio-Cervico-Mandibular Malalignment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Comparative Double-Blind Study
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Exercise Group (Control Group)
Arm Type
Active Comparator
Arm Description
Conventional neck exercises were applied to the control group.
Arm Title
Scapulothoracic Exercise (Treatment Group)
Arm Type
Experimental
Arm Description
In the treatment group, scapulothoracic exercises were applied in addition to conventional neck exercises.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
For control group; Cervical conventional exercises. For treatment group; scapulothoracic exercises including strengthening, proprioceptive and stabilization exercises in addition to cervical conventional exercises
Primary Outcome Measure Information:
Title
Postural Stability
Description
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.
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.
Title
Joint Position Sense
Description
Mandibular and cervical joint position sense measurements were made.
Time Frame
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 Outcome Measure Information:
Title
Muscle Strength
Description
Isometric muscle strength test will be performed on TMJ depressor muscles and cervical region muscles.
Time Frame
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
Title
Endurance Measurement of Deep Neck Flexor Muscles
Description
The muscular endurance measurement of the deep neck flexors will be made using the "craniocervical flexion test" and a stabilizer device.
Time Frame
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.
Title
Mandibular Function Disorder Questionnaire (MFBA)
Description
It is used to evaluate the level of impairment in jaw functions in patients with TMED.
Time Frame
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 Pre-specified Outcome Measures:
Title
Body Mass Index
Description
Height and body weights were measured to measure the body mass index of the participants.
Time Frame
Body Mass Index was measured at pre-treatment period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Micoogullari, MSc
Organizational Affiliation
Cyprus International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cyprus International University
City
Mersin
State/Province
Lefkosa
ZIP/Postal Code
99040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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).
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
19148396
Citation
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.
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PubMed Identifier
32071851
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PubMed Identifier
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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).
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Efficacy of Scapulothoracic Exercises on Postural Stability, Proprioception, Muscular Features and Mandibular Functions

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