Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05749224 |
| Other study ID # |
DenizOzluer |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2023 |
| Est. completion date |
May 26, 2023 |
Study information
| Verified date |
December 2022 |
| Source |
Yeditepe University |
| Contact |
Deniz Ozluer, Master |
| Phone |
+905327870367 |
| Email |
denizzozluer[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
