Effect of Progressive Neck Motor Control Exercises on Temporomandibular Joint Dysfunction

January 27, 2025 updated by: Nurhayat KORKMAZ, Karadeniz Technical University

Investigation of the Effect of Progressive Neck Motor Control Exercises on Craniocervical Pain, Posture, Function and Kinesiophobia in Different Types of Temporomandibular Joint Dysfunction

The primary aim of this study was to investigate the effects of progressive neck motor control exercises on craniocervical pain, posture, function and kinesiophobia in different types of temporomandibular dysfunction. The secondary aim of the study was to examine the differences between the effects of progressive neck motor control exercises on different types of temporomandibular dysfunction.

Study Overview

Status

Status

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

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

In this randomised controlled study, the effects of progressive neck motor control exercise therapy on craniocervical pain, posture, function and kinesiophobia in individuals with different types of temporomandibular dysfunction (myofascial, disc displacement with reduction, disc displacement without reduction) and their differences with the control group will be compared. Participants diagnosed by a dentist according to three different types of temporomandibular dysfunction will be included in the study. Participants will be divided into groups by block randomisation method. A total of 6 groups will be included in the study, including participants with three different types of temporomandibular dysfunction who voluntarily agree to participate in the study and meet the inclusion criteria, and the control group of each group. The study groups will receive the same treatment and patient education for 6 weeks, while the control groups will receive only patient education.

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.
Interventional

Enrollment (Estimated)

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.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Trabzon, Turkey
        • Recruiting
        • Karadeniz Technical University
        • Contact:
          • nurhayat korkmaz, MSc
        • Contact:
          • Nurhayat Korkmaz, Msc
          • Phone Number: 2471 +90462377

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

Description

Inclusion Criteria:

  • 18 to 55 years old,
  • Temporomandibular joint-related complaints for at least 3 months,
  • Temporomandibular dysfunction is diagnosed as a result of clinical and radiological evaluation by the dentist,
  • Neck pain of 3 or more according to the numeric pain scale

Exclusion Criteria:

  • Cognitive problems,
  • The one with the splint,
  • Those who have used painkillers or muscle relaxants for temporomandibular dysfunction complaints in the last 1 week,
  • With any systematic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
  • Those with serious systemic diseases,
  • Any neurological disorder (e.g. trigeminal neuralgia),
  • Pregnancy or breastfeeding,
  • Treated for Temporomandibular joint or orofacial muscle pain in the last 3 months,
  • Has undergone an operation/trauma to the cervical region and/or temporomandibular joint,
  • Positive vertebrobasilar artery test

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Myofascial
Myofascial Temporomandibular Dysfunction
Other: Progressive neck motor control exercise therapy
The exercise programme will be conducted as a single session two days a week for 6 weeks. The sessions will always be conducted by the same physiotherapist. Each exercise session will consist of 10 minutes of warm-up exercises, 40 minutes of neck motor control exercises and 10 minutes of cool down exercises. Each exercise will be performed as 2 sets of 10 repetitions.
Other: Patient education
The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.
Experimental: disc displacement with reduction
Temporomandibular joint disc displacement with reduction
Other: Progressive neck motor control exercise therapy
The exercise programme will be conducted as a single session two days a week for 6 weeks. The sessions will always be conducted by the same physiotherapist. Each exercise session will consist of 10 minutes of warm-up exercises, 40 minutes of neck motor control exercises and 10 minutes of cool down exercises. Each exercise will be performed as 2 sets of 10 repetitions.
Other: Patient education
The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.
Experimental: disc displacement without reduction
Temporomandibular joint disc displacement without reduction
Other: Progressive neck motor control exercise therapy
The exercise programme will be conducted as a single session two days a week for 6 weeks. The sessions will always be conducted by the same physiotherapist. Each exercise session will consist of 10 minutes of warm-up exercises, 40 minutes of neck motor control exercises and 10 minutes of cool down exercises. Each exercise will be performed as 2 sets of 10 repetitions.
Other: Patient education
The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.
Other: Myofascial2
Myofascial Temporomandibular Dysfunction
Other: Patient education
The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.
Other: disc displacement with reduction2
Temporomandibular joint disc displacement with reduction
Other: Patient education
The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.
Other: disc displacement without reduction2
Temporomandibular joint disc displacement without reduction
Other: Patient education
The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.

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
Measure Description
Time Frame
Fonseca Anamnestic Index
Time Frame: 1st, sixth week, first mont
Assessment of Temporomandibular Dysfunction Severity
1st, sixth week, first mont
Pressure pain threshold
Time Frame: 1st, sixth week, first mont
Assessment of Pressure pain threshold
1st, sixth week, first mont
Range of motion
Time Frame: 1st, sixth week, first mont
Assessment of Temporomandibular joint and neck range of motion
1st, sixth week, first mont
Joint position error test
Time Frame: 1st, sixth week, first mont
Assessment of Cervical proprioception
1st, sixth week, first mont
Endurance
Time Frame: 1st, sixth week, first mont
Assessment of Deep neck flexor endurance
1st, sixth week, first mont
Mandibular Function Impairment Questionnaire
Time Frame: 1st, sixth week, first mont
Assessment of Mandibular Function
1st, sixth week, first mont
Numeric Pain Scale
Time Frame: 1st, sixth week, first mont
Assessment of Pain, 0: No pain, 10: Maximum pain
1st, sixth week, first mont
Photographic Posture Analysis
Time Frame: 1st, sixth week, first mont
Assessment of head and neck posture
1st, sixth week, first mont

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
Measure Description
Time Frame
Tampa kinesiophobia scale
Time Frame: 1st, sixth week, first mont
Assessment of kinesiophobia for temporomandibular joint, 12 points: low kinesiophobia; 48 points:high kinesiophobia
1st, sixth week, first mont

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.
Karadeniz Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurhayat Korkmaz, PhDstudent, Karadeniz Technical 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 4, 2024

Primary Completion (Estimated)

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.
May 30, 2025

Study Completion (Estimated)

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.
June 30, 2025

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).
November 20, 2023

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.
November 20, 2023

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.
November 28, 2023

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.
March 25, 2025

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.
January 27, 2025

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.
October 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 2023/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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