Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
Primary Purpose
Temporomandibular Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Helkimo Index
Sponsored by
About this trial
This is an interventional diagnostic trial for Temporomandibular Disorder focused on measuring helkimo index, temporomandibular disorders, Turkish validity and reliability
Eligibility Criteria
Inclusion Criteria: Age over 18 Exclusion Criteria: History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients Who Have Temporomandibular Joint Disorder
Healthy Controls
Arm Description
Helkimo index will be applied to the patients have temporomandibular disorder.
Helkimo index will be applied to healthy people.
Outcomes
Primary Outcome Measures
Helkimo Index for Diagnosis of Temporomandibular Disorders
Turkish Validity and Reliability Study
Questionnaire for Anamnestic Component of Helkimo Index
It is an anamnestic component questionnaire consisting of 8 different questions asked verbally to the participants and forming the first part of the Helkimo index.
Clinical Dysfunction Component of Helkimo Index
It is a clinical dysfunction questionnaire that constitutes the second part of the helkimo index, in which the temporamandibular joint of the participants is evaluated physically with 5 different parameters.
Secondary Outcome Measures
SF-12
Quality of life
Full Information
NCT ID
NCT05749224
First Posted
December 24, 2022
Last Updated
February 28, 2023
Sponsor
Yeditepe University
1. Study Identification
Unique Protocol Identification Number
NCT05749224
Brief Title
Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
Official Title
Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Helkimo Index evaluates movement, joint function, pain and musculature, providing a quick general overview that could be very useful at different levels of care. The aim of this study is to investigate the validity and reliability of the Turkish version of the Helkimo index. Registration of subjective symptoms applying for the Helkimo Index required a questionnaire-based survey. Questionnaire comprised two parts: Anamnestic component which includes answers to questions in "yes" or "no". Clinical dysfunction part comprised clinical examination. Method: Turkish translation of Helkimo index will be made. The sample will consist of 100 subjects, 50 TMD patients and 50 healthy controls. the patients will be selected, demographic data were recorded: age, sex, height, weight, body mass index (BMI), educational level, work situation, smoking status, alcoholic habits and physical activity. Helkimo Index is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25. The Numerical Pain-Rating Scale (NPRS) test, disability, the Neck Disability Index test, the Dizziness Handicap Inventory (DHI), the Headache Impact Test (HIT-6) and 12-item Short-Form Health Survey (SF-12) will be assessed. Correlation will be made between the Helkimo index and these rating scales.
Detailed Description
Temporomandibular disorder (TMD) is a wide-ranging term used to describe a number of related disorders involving the temporomandibular joint (TMJ), masticatory muscles, and occlusion, with common symptoms such as pain, restricted movement, muscle tenderness, and intermittent joint sounds. TMDs can also be defined as a collective term for conditions that involve pain and/or dysfunction of the TMJ and the related structures. The Helkimo Clinical Dysfunction Index (HCDI) has been widely used for the clinical diagnosis of TMDs. It is a simple and quick test that assesses limitations of mandibular movement, pain and joint function. However, the studies that analyze the reliability and validity of this tool are old, used a very small sample, applied incorrect statistical techniques and were limited to the analysis of a single clinometric property. The diagnostic validity of the HCDI was measured according to diagnostic criteria for temporomandibular disorders (DC/TMDs) protocol, which is the gold-standard diagnostic test for TMD. The DC/TMD protocol is composed of 12 items that assess muscle and joint pain, pain during jaw movement, headache, bites, noise, obstacles or blockages during jaw movement and discomfort in the palpation of the muscles of the temporomandibular joint. Finally, a diagnostic tree is used to specify a diagnostic result. The DC/TMD protocol has a sensitivity of 86%, a specificity of 98% and an inter-examination reliability of 85%. The main measure was the HCDI. The instrument is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25.
Pain perception will be evaluated by the Numerical Pain-Rating Scale (NPRS) test. The subjects indicate their perceived pain with a number between 0 (no pain) and 10 (the worst pain possible). This tool is used to quantify both the neck and the temporomandibular joint and is the pain assessment.
To evaluate the possibility of associate neck disability, the Neck Disability Index test will be used; it is a 10-question survey, with answers being reported as a number between 0 and 5. For each question, a score of 0 refers to the total absence of disability, while a score of 5 refers to total disability. In this line, a total score between 0 and 5 indicates absence of disability, 5-14 points indicate low disability, 15-24 point indicates moderate disability and 35-50 points indicate great disability.
The presence of vertigo and balance problems will be assessed by the Dizziness Handicap Inventory (DHI). This questionnaire is composed of 25 questions that can be answered with yes, no or sometimes, scoring 4, 0 and 2 points, respectively. This questionnaire assesses physical, emotional and functional dimensions, each of which has an independent score in addition to the total score.
Headache-associated symptoms will be measured with the Headache Impact Test (HIT-6), which is an evaluation questionnaire consisting of six questions that can be answered with usual, almost always, sometimes, rarely and never, with a total score between 36 and 78 points.
Finally, the quality of life will be assessed using the 12-item Short-Form Health Survey (SF-12). This questionnaire is the short version of the SF-36 and retains its self-administered form. It results in a Mental Component Summary score and a Physical Component Summary score (PCS-12), differentiating between the two components of the quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
helkimo index, temporomandibular disorders, Turkish validity and reliability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients Who Have Temporomandibular Joint Disorder
Arm Type
Experimental
Arm Description
Helkimo index will be applied to the patients have temporomandibular disorder.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Helkimo index will be applied to healthy people.
Intervention Type
Diagnostic Test
Intervention Name(s)
Helkimo Index
Intervention Description
Helkimo Index is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25.
Primary Outcome Measure Information:
Title
Helkimo Index for Diagnosis of Temporomandibular Disorders
Description
Turkish Validity and Reliability Study
Time Frame
3 months
Title
Questionnaire for Anamnestic Component of Helkimo Index
Description
It is an anamnestic component questionnaire consisting of 8 different questions asked verbally to the participants and forming the first part of the Helkimo index.
Time Frame
3 months
Title
Clinical Dysfunction Component of Helkimo Index
Description
It is a clinical dysfunction questionnaire that constitutes the second part of the helkimo index, in which the temporamandibular joint of the participants is evaluated physically with 5 different parameters.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
SF-12
Description
Quality of life
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age over 18
Exclusion Criteria:
History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Ozluer, Master
Phone
+905327870367
Email
denizzozluer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hazal Yeşilkaya, PhD
Phone
+905312281723
Email
yesilkayahazal@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Tugce Cil, PhD
Organizational Affiliation
Yeditepe University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Cultural adaptation of the Helkimo index to Turkish society will be done.
IPD Sharing Time Frame
In 2023 - Infinite Access
IPD Sharing Access Criteria
No access criteria
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8000811/pdf/diagnostics-11-00472.pdf
Description
Validity and Reliability of the Helkimo Clinical Dysfunction Index for the Diagnosis of Temporomandibular Disorders
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5308067/pdf/JIPS-17-48.pdf
Description
Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional study
Learn more about this trial
Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
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