- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06141863
Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
November 20, 2023 updated by: Turgay Altunalan, Karadeniz Technical University
Investigation of Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study included diagnosed with cervical disc herniation.
The participants were divided into two groups based on their The Neck Disability Index (NDI) score: Group 1 with no disability and mild disability and Group 2 with moderate and severe disability.
Temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.
Study Type
Observational
Enrollment (Actual)
60
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
-
-
-
Trabzon, Turkey, 61000
- Karadeniz Technical 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
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Individuals diagnosed with cervical disc herniation.
Patients who were referred to physiotherapy after diagnosis were evaluated in terms of study suitability before starting treatment.
We divided the participants into two groups based on their level of neck disability to compare their TMD.
Description
Inclusion Criteria:
- Diagnosed with cervical disc herniation aged between 18 and 65,
- who could read and write in Turkish
Exclusion Criteria:
- Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
- presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis
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 |
|---|---|
|
Group 1
no disability and mild disability
|
Neck Disability Index, The Fonseca Anamnestic Index (FAI) and Visual Analogue Scale (VAS)
|
|
Group 2
moderate and severe disability
|
Neck Disability Index, The Fonseca Anamnestic Index (FAI) and Visual Analogue Scale (VAS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: one day assessment
|
Assessment of neck disability
|
one day assessment
|
|
Fonseca Anamnestic Index
Time Frame: one day assessment
|
Assessment of temporomandibular dysfunction
|
one day assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: one day assessment
|
Assessment of temporomandibular joint pain and neck pain intensity
|
one day assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Turgay Altunalan, Assist Prof, Karadeniz Technical University
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)
May 1, 2022
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
November 15, 2023
First Submitted That Met QC Criteria
November 20, 2023
First Posted (Estimated)
November 21, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Hernia
- Myofascial Pain Syndromes
- Intervertebral Disc Displacement
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
Other Study ID Numbers
- 6135131342/2022-28
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.
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