- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407127
Cervical Muscle Endurance and Pressure Pain Threshold in University Students With TMD: A Case-Control Study (TMED-CME-PPT)
Investigation of Cervical Muscle Endurance and Pressure Pain Threshold in University Students With Temporomandibular Joint Dysfunction: A Case-Control Study
Aim: This study aims to compare the static endurance of cervical region muscles, pressure pain thresholds of selected muscles of the stomatognathic system, and postural characteristics in young adults with and without temporomandibular joint dysfunction (TMD).
Method: A total of 60 university students aged between 18 and 25 years will be included in the study. Participants will be divided into two groups: individuals with temporomandibular joint dysfunction (TMD group, n=30) and healthy controls (control group, n=30). The static endurance of cervical flexor and extensor muscles will be assessed using standardized endurance tests. Pressure pain thresholds of the temporalis, masseter, sternocleidomastoid, and upper trapezius muscles will be measured using a pressure algometer. Postural characteristics will be evaluated using the New York Posture Analysis (NYPA).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Iğdır, Turkey (Türkiye), 76000
- Igdir University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Currently enrolled as a student at Igdır University.
- The inclusion criterion for the TMD group was defined as scoring 15 points or more on the Fonseca Anamnesis Index (FAI), while the criterion for the control group was an FAI score below 15.
Exclusion Criteria:
- Underwent surgery in the neck or mandibular regions
- Had a history of intervertebral disk problems, regardless of clinical symptoms
- Experienced mechanical neck pain for ≥3 months
- Had scoliosis
- Had reducible or irreducible displacement of the temporomandibular joint disk
- Had a history of trigeminal neuralgia
- Were undergoing orthodontic dental treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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TMD Group
TMD group was defined as scoring 15 points or more on the Fonseca Anamnesis Index (FAI).
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Control Group
Control group was an FAI score below 15.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cervical Muscle Endurance Assessment
Time Frame: 2 week
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Static endurance of cervical flexor and extensor muscles was measured in seconds.
Extensors: participants lay prone, lifted the head slightly, and held a 2-kg weight as long as possible.
Flexors: participants lay supine, performed slight craniocervical flexion, and maintained the position.
Test ended with pain, loss of position, or sufficient endurance.
Intra-observer reliability: flexors 0.71-0.93,
extensors 0.73-0.85.
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2 week
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Pressure Pain Threshold Assesment
Time Frame: 2 week
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Pressure pain threshold (PPT) was measured using a Baseline Push-Pull Force Gauge® algometer with a 1 cm rubber tip.
After familiarization, pressure was applied perpendicularly to the most sensitive points of the upper trapezius, masseter, temporalis, and SCM muscles until participants reported pain.
Each site was tested three times with ≥20 s intervals, and the average value was recorded as the PPT.
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2 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Posture Assessment
Time Frame: 2 week
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Posture was assessed using the NYPA, evaluating alignment of 13 body regions including head, neck, shoulders, back, waist, hips, and ankles.
Each region was scored 1 (severe impairment), 3 (moderate), or 5 (good), giving a total score of 13-65.
Scores were categorized as very good (≥45), good (40-44), moderate (30-39), poor (20-29), or bad (≤19).
Reliability coefficients range from 0.93 to 0.98.
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2 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aydan AYTAR, Prof. Dr., University of Health Sciences, Gulhane Faculty of Physiotherapy and Rehabilitation
- Principal Investigator: Binnaz Bozkurt Akpulat, MSc., Igdir University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGDU-EC-27-03-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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