- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06472141
Effectiveness of Cervical Stabilization Exercises in Individuals With Temporomandibular Joint Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals included in the study will be divided into 2 groups, Stabilization and Control groups, by block randomization method. A standard treatment program (Education + home exercises) will be applied to both groups. In addition to the stabilization group, cervical stabilization exercises will be applied. Individuals will be evaluated with the Sociodemographic Data Form before the application.
Before and after the application, individuals were assessed for TMJ pain with the Numeric Pain Rating Scale (NPRS), TMJ symptom severity with the Fonseca Anamnestic Index (FAI) and cervical posture, mobility and muscle performance will be evaluated with craniovertebral angle, goniometer and craniocervical flexion test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bitlis
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Merkez, Bitlis, Turkey, 13000
- Bitlis Eren Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a TMJ disorder according to the TMJ Disorders Research Diagnostic Criteria (RDC/TMD),
- Being between the ages of 18-65,
Exclusion Criteria:
- Neurological diseases (such as Multiple Sclerosis, Parkinson's disease),
- Metabolic and systemic diseases (such as Hypothyroidism, Hypercalcemia, Diabetes mellitus, Celiac disease),
- Rheumatologic diseases (such as Rheumatoid arthritis, Scleroderma),
- History of head and spine trauma/surgery in the last 6 months,
- History of malignancy and pregnant women will be excluded.
Study Plan
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 |
|---|---|
|
Active Comparator: Control group
The control group will receive a standard treatment (education + home exercises) program.
|
Individuals will be informed about TMJ disorders, parafunctional activities (chewing gum, nail/pen biting, etc.) and recommendations.
In addition, Rocabado exercises will be given as a home program.
|
|
Experimental: Stabilization group
The stabilization group will receive cervical stabilization exercises in addition to standard treatment.
|
Individuals will be informed about TMJ disorders, parafunctional activities (chewing gum, nail/pen biting, etc.) and recommendations.
In addition, Rocabado exercises will be given as a home program.
Cervical Stabilization Exercises will be performed 3 days a week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Posture
Time Frame: Change from baseline at 8 weeks
|
Cervical posture will be evaluated from the craniovertebral angle.
|
Change from baseline at 8 weeks
|
|
Cervical Mobility
Time Frame: Change from baseline at 8 weeks
|
For cervical mobility, normal joint movements of the neck will be evaluated with a goniometer.
|
Change from baseline at 8 weeks
|
|
Cervical Muscle Performance
Time Frame: Change from baseline at 8 weeks
|
Cervical muscle performance will be evaluated with the craniocervical flexion test.
|
Change from baseline at 8 weeks
|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: Change from baseline at 8 weeks
|
TMJ pain will be evaluated at rest with the NPRS scale.
It is a scale scored between 0-10 points and '0 points means 'I have no pain' and '10 points means 'I have unbearable pain'.
NRS score between 1-3 points indicates mild pain, between 4-6 points indicates moderate pain and between 7-10 points indicates severe pain.
|
Change from baseline at 8 weeks
|
|
Fonseca Anamnestic Index (FAI)
Time Frame: Change from baseline at 8 weeks
|
It assesses TMJ disorder and its severity.
The index includes three options: "yes" (10 points), "sometimes" (5 points) and "no" (0 points).
A total score of 0-15 is considered as no TMJ disorder, 20-40 as mild, 45-65 as moderate, and 70-100 as severe.
|
Change from baseline at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jaw Function Limitation Scale (JFSL-20)
Time Frame: Change from baseline at 8 weeks
|
It is a 20-question scale that evaluates the extent to which jaw functions are restricted with a score between 0-10.
A high score on the scale indicates a high level of impairment.
|
Change from baseline at 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMJD-EXERCISE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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