- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06623552
Relationship Between Cervical Pain and Temporomandibular Dysfunction Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility (TMJ)
October 1, 2024 updated by: Yeditepe University
The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.
Study Overview
Status
Completed
Conditions
Detailed Description
This study was conducted with 129 individuals (mean age 34.08:years, M/F=52/77) to determine the possible relationships between Cervical Pain and Temporomandibular Dysfunction, Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility.
Pati,ents were assessed with Neck Pain and Disability Questionnaire , Fonseka Anamnestic Index , goniometric measurements, ,Cervical Mobility Measurement.
JFSL-20 questionnaire and Craniovertebral Angle measurement was made by photographic method.
Study Type
Observational
Enrollment (Actual)
129
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Yeditepe University
-
-
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
Sampling Method
Probability Sample
Study Population
All individuals in the study were included on a voluntary basis.All participants were informed about the study before the evaluations and the consent form was signed (Appendix- ).All necessary evaluations for the study were carried out on the same day.During the study, both the participants in the study group and the participants in the control group completed the evaluation completely.No health problems were observed in any participant during and after the evaluations.
Description
Inclusion Criteria:
Neck pain disability score below 15 Not having painting problem for TME Being in the age range of 18-50 Volunteering to participate in the study
Exclusion Criteria:
- he presence of any orthopedic and / or neurological problem that may prevent evaluations.
Being diagnosed with any psychiatric disorder Situations that will prevent evaluation or communication
- Illiterate individuals
- Head, neck and maxillofacial surgery operation history
- Conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control Group
the population without cervical pain or with a cut off value of less than 15 for neck pain and disability score(NPDS) were selected as the control group
|
The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain.
The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain".
The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain
It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity.
The Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw.
In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation).
Higher scores are a more serious sign of functional limitation.
|
|
Study Group
the population without cervical pain or with a cut off value of more than 15 for neck pain and disability score(NPDS) were selected as the study group
|
The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain.
The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain".
The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain
It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity.
The Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw.
In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation).
Higher scores are a more serious sign of functional limitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neck Pain and Disability Scale (NPDS):
Time Frame: one day
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fonseca Anamnestic Index (FAI):
Time Frame: one day
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 1, 2020
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
March 30, 2021
Study Registration Dates
First Submitted
September 30, 2024
First Submitted That Met QC Criteria
October 1, 2024
First Posted (Actual)
October 2, 2024
Study Record Updates
Last Update Posted (Actual)
October 2, 2024
Last Update Submitted That Met QC Criteria
October 1, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMJ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Temporomandibular Disorder
-
McGill University Health Centre/Research Institute...Not yet recruitingTemporomandibular Joint | Temporomandibular Dysfunction (TMD) | Temporomandibular Joint and Muscle Disorder | Temporo-mandibular Dysfunction | Temporomandibular Disorder (TMD) | Temporomandibular Disorders (TMDs)Canada
-
Tel-Aviv Sourasky Medical CenterEnrolling by invitationTemporomandibular Disorders (TMD) | Temporomandibular Dysfunction (TMD) | Temporomandibular Joint and Muscle DisorderIsrael
-
CES UniversityCompletedTemporomandibular Disorder | Children, Only | Pain Disorder | Joint Disorder, Temporomandibular
-
B.P. Koirala Institute of Health SciencesCompletedTemporomandibular Joint Disorder | Temporomandibular Disorders (TMD)Nepal
-
Cairo UniversityNot yet recruitingTemporomandibular Disorder | TMJ Disc Disorder | Temporomandibular Joint Disc Displacement, Without Reduction | TMD/Orofacial Pain | TMJ Closed LockEgypt
-
University of AlcalaCompletedTemporomandibular DisorderSpain
-
Semmelweis UniversityBajcsy-Zsilinszky HospitalRecruitingOrofacial Pain | Temporomandibular Disorders (TMD) | Temporomandibular Joint and Muscle Disorder | TMD/Orofacial Pain | Temporo-mandibular Dysfunction | Temporomandibular Disorder (TMD) | Temporomandibular Disorders (TMDs)Hungary
-
University of Nove de JulhoUnknownTemporomandibular DisorderBrazil
-
University of MinnesotaRecruitingTemporomandibular DisorderUnited States
-
Bahçeşehir UniversityCompletedTemporomandibular Joint DisorderTurkey (Türkiye)
Clinical Trials on Neck Pain and Disability Scale (NPDS)
-
Al- Shifa Physiotherapy Institute /ClinicCompleted
-
Konya Beyhekim Training and Research HospitalNot yet recruiting
-
Bandırma Onyedi Eylül UniversityCompleted
-
Cairo UniversityCompletedSex-Based Differences in Cervical Joint Position Sense in Patients With Chronic Mechanical Neck PainChronic Mechanical Neck PainEgypt
-
Cumhuriyet UniversityRecruitingDepression | Sleep | Anxiety | Pain, Chronic | Sleep Hygiene | Coccyx InjuriesTurkey
-
Ankara City Hospital BilkentCompleted
-
Marmara UniversityActive, not recruitingChronic Pain | Central Sensitisation | Chronic Musculoskeletal DiseaseTurkey
-
Ahram Canadian UniversityCompletedIncidence of Headache and Its Effect on Quality of Life in Geriatric Patients With Chronic Neck PainGeriatric Patients With Neck PainEgypt
-
Spine Centre of Southern DenmarkCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheTerminated