- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148818
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
75
Phase
- 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
- Name: nurhayat korkmaz, PhDstudent
- Phone Number: 9062 +90538736
- Email: krkmznrhyt@gmail.com
Study Contact Backup
- Name: Nurhayat Korkmaz, MSc
- Phone Number: 9062 +90538736
- Email: krkmznrhyt@gmail.com
Study Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Myofascial
Myofascial Temporomandibular Dysfunction
|
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.
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
|
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.
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
|
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.
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
|
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
|
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
|
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
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
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
Investigators
- 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)
November 4, 2024
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
November 20, 2023
First Submitted That Met QC Criteria
November 20, 2023
First Posted (Actual)
November 28, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 27, 2025
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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