Neck PainNCT06874816
Masseter Thickness, Bruxism, and Oral Behaviors in Chronic Neck Pain
An observational study of Neck Pain, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
A total of 30 patients aged 18-65 years who present with chronic non-specific neck pain and 30 healthy volunteers will be included in the study. Patients with symptoms persisting for at least 3 months will be eligible for inclusion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 10 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of 30 patients diagnosed with chronic non-specific neck pain and 30 healthy volunteers, aged between 18 and 65 years.
Who may be able to join
- Diagnosed with chronic non-specific neck pain
- Aged between 18-65 years
- Symptoms persisting for at least 3 months
Who cannot join
- Pregnancy
- Presence of psychiatric or neurological diseases
- Use of psychiatric medications
- Cognitive impairment
- History of neck injection or surgery within the last 6 months
- Presence of rheumatic diseases
Show all 11Show fewer
- Spinal stenosis
- Cervical disc herniation
- Advanced degeneration detected in radiological imaging
- History of fracture or surgery in the temporomandibular joint
- Presence of inflammatory, rheumatologic diseases, or malignancy affecting the t--emporomandibular joint
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
Büşra Şirin, 02124443322, bsrn080@gmail.com
Büşra Şirin Ahısha, MD
About this study
Official title: Does Your Jaw Tell the Story of Your Pain? Masseter Muscle Thickness, Bruxism, and Oral Behaviors in Chronic Non-Specific Neck Pain
A total of 30 patients aged 18-65 years who present with chronic non-specific neck pain and 30 healthy volunteers will be included in the study. Patients with symptoms persisting for at least 3 months will be eligible for inclusion. Necessary information will be provided to all participants, and informed consent will be obtained.
To assess pain severity before treatment, participants will be asked to rate their complaints using the Visual Analog Scale (VAS), a linear scale for pain assessment. The Neck Disability Index will be used to determine the level of disability.
Read more
The Jaw Functional Limitation Scale-20 (JFLS-20), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15: Physical Symptoms, Generalized Anxiety Disorder-7 (GAD-7), and the Oral Behaviors Checklist-included in Axis 2 of the DC/TMD form developed for evaluating temporomandibular joint dysfunction-will be used to assess patients' psychosocial characteristics and parafunctional habits.
Additionally, masseter muscle thickness will be evaluated using ultrasonographic measurement.
- Conditions
- Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neck pain group | Patients with chronic non specific neck pain | |
| Healthy controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter Muscle Thickness
Measured using ultrasonography, with values interpreted in relation to clinical findings. No fixed score range; thickness is recorded in millimeters.
Measured: 0 day
Secondary outcomes (6)
Visual Analog Scale (VAS)
A linear scale used to assess pain severity, where higher scores indicate more severe pain. Score range: 0-10.
Measured: 0 day
Neck Disability Index
A questionnaire used to evaluate the level of disability related to neck pain, with higher scores reflecting greater disability. Score range: 0-100.
Measured: 0 day
Patient Health Questionnaire-9 (PHQ-9)
A scale measuring the severity of physical symptoms, where higher scores represent greater somatic symptom burden. Score range: 0-30.
Measured: 0 day
Generalized Anxiety Disorder-7 (GAD-7)
A scale used to assess anxiety levels, with higher scores indicating more severe anxiety symptoms. Score range: 0-21.
Measured: 0 day
Jaw Functional Limitation Scale-20 (JFLS-20)
A tool used to evaluate functional limitations of the jaw, where higher scores indicate greater impairment. Score range: 0-100.
Measured: 0 day
Oral Behaviors Checklist
A questionnaire used to identify parafunctional oral habits, with higher scores reflecting more frequent parafunctional activities. No predefined score range; higher scores indicate greater frequency.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Mar 2025
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874816
- Sponsor's protocol ID
- Beylikdüzüstateh14
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Your Jaw Tell the Story of Your Pain? Masseter Muscle Thickness, Bruxism, and Oral Behaviors in Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT06874816
- Acronym / sponsor ID
- Beylikdüzüstateh14
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 30 patients aged 18-65 years who present with chronic non-specific neck pain and 30 healthy volunteers will be included in the study. Patients with symptoms persisting for at least 3 months will be eligible for inclusion. Necessary information will be provided to all participants, and informed consent will be obtained.
To assess pain severity before treatment, participants will be asked to rate their complaints using the Visual Analog Scale (VAS), a linear scale for pain assessment. The Neck Disability Index will be used to determine the level of disability.
The Jaw Functional Limitation Scale-20 (JFLS-20), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15: Physical Symptoms, Generalized Anxiety Disorder-7 (GAD-7), and the Oral Behaviors Checklist-included in Axis 2 of the DC/TMD form developed for evaluating temporomandibular joint dysfunction-will be used to assess patients' psychosocial characteristics and parafunctional habits.
Additionally, masseter muscle thickness will be evaluated using ultrasonographic measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck pain group | – | –Patients with chronic non specific neck pain |
| Healthy controls | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 30 patients diagnosed with chronic non-specific neck pain and 30 healthy volunteers, aged between 18 and 65 years.
Key inclusion criteria (3 listed)
- Diagnosed with chronic non-specific neck pain
- Aged between 18-65 years
- Symptoms persisting for at least 3 months
Key exclusion criteria (11 listed)
- Pregnancy
- Presence of psychiatric or neurological diseases
- Use of psychiatric medications
- Cognitive impairment
- History of neck injection or surgery within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Masseter Muscle Thickness
Time frame: 0 day
Measured using ultrasonography, with values interpreted in relation to clinical findings. No fixed score range; thickness is recorded in millimeters.
6 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 0 day
Neck Disability Index
Time frame: 0 day
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 0 day
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0 day
Jaw Functional Limitation Scale-20 (JFLS-20)
Time frame: 0 day
Oral Behaviors Checklist
Time frame: 0 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter Muscle Thickness (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.