Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2023
CompletedMarch 1, 2023
December 1, 2022
2 months
December 24, 2022
February 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Helkimo Index for Diagnosis of Temporomandibular Disorders
Turkish Validity and Reliability Study
3 months
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.
3 months
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.
3 months
Secondary Outcomes (1)
SF-12
3 months
Study Arms (2)
Patients Who Have Temporomandibular Joint Disorder
EXPERIMENTALHelkimo index will be applied to the patients have temporomandibular disorder.
Healthy Controls
EXPERIMENTALHelkimo index will be applied to healthy people.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age over 18
You may not qualify if:
- History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elif Tugce Cil, PhD
Yeditepe University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2022
First Posted
March 1, 2023
Study Start
March 15, 2023
Primary Completion
May 15, 2023
Study Completion
May 26, 2023
Last Updated
March 1, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- In 2023 - Infinite Access
- Access Criteria
- No access criteria
Cultural adaptation of the Helkimo index to Turkish society will be done.