Relationship Between Cervical Pain and Temporomandibular Dysfunction Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility (TMJ)

October 1, 2024 updated by: Yeditepe University
The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was conducted with 129 individuals (mean age 34.08:years, M/F=52/77) to determine the possible relationships between Cervical Pain and Temporomandibular Dysfunction, Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility. Pati,ents were assessed with Neck Pain and Disability Questionnaire , Fonseka Anamnestic Index , goniometric measurements, ,Cervical Mobility Measurement. JFSL-20 questionnaire and Craniovertebral Angle measurement was made by photographic method.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Yeditepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All individuals in the study were included on a voluntary basis.All participants were informed about the study before the evaluations and the consent form was signed (Appendix- ).All necessary evaluations for the study were carried out on the same day.During the study, both the participants in the study group and the participants in the control group completed the evaluation completely.No health problems were observed in any participant during and after the evaluations.

Description

Inclusion Criteria:

Neck pain disability score below 15 Not having painting problem for TME Being in the age range of 18-50 Volunteering to participate in the study

Exclusion Criteria:

  • he presence of any orthopedic and / or neurological problem that may prevent evaluations.

Being diagnosed with any psychiatric disorder Situations that will prevent evaluation or communication

  • Illiterate individuals
  • Head, neck and maxillofacial surgery operation history
  • Conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Group
the population without cervical pain or with a cut off value of less than 15 for neck pain and disability score(NPDS) were selected as the control group
Other: Neck Pain and Disability Scale (NPDS)
The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain. The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain". The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain
Other: Fonseca Anamnestic Index (FAI)
It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity.
Other: Evaluation of Jaw Functional Limitation
The Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw. In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation). Higher scores are a more serious sign of functional limitation.
Study Group
the population without cervical pain or with a cut off value of more than 15 for neck pain and disability score(NPDS) were selected as the study group
Other: Neck Pain and Disability Scale (NPDS)
The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain. The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain". The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain
Other: Fonseca Anamnestic Index (FAI)
It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity.
Other: Evaluation of Jaw Functional Limitation
The Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw. In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation). Higher scores are a more serious sign of functional limitation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Neck Pain and Disability Scale (NPDS):
Time Frame: one day
one day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Fonseca Anamnestic Index (FAI):
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yeditepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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