ClinicalTrials.gg
RecruitingNCT06874816Updated Mar 26, 2025

Masseter Thickness, Bruxism, and Oral Behaviors in Chronic Neck Pain

An observational study in Neck Pain, sponsored by Beylikduzu State Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Beylikduzu State Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neck Pain

Browse trials for

03

In context

Neck Pain

1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 226 observational studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Beylikduzu State Hospital is the lead sponsor of 23 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with chronic non-specific neck pain
  • Aged between 18-65 years
  • Symptoms persisting for at least 3 months

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 affecting the t--emporomandibular joint
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neck pain group

    Patients with chronic non specific neck pain

  • Healthy controls

    Healthy controls

06

What researchers measure

Primary outcomes

  1. Masseter Muscle Thickness

    Measured using ultrasonography, with values interpreted in relation to clinical findings. No fixed score range; thickness is recorded in millimeters.

    Time frame: 0 day

Secondary outcomes

  1. Visual Analog Scale (VAS)

    A linear scale used to assess pain severity, where higher scores indicate more severe pain. Score range: 0-10.

    Time frame: 0 day

  2. 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.

    Time frame: 0 day

  3. 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.

    Time frame: 0 day

  4. 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.

    Time frame: 0 day

  5. 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.

    Time frame: 0 day

  6. 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.

    Time frame: 0 day

07

Study locations

1 of 1 sites recruiting
  • Beylikdüzü State Hospital
    Istanbul, Beylikdüzü 34147, Turkey
    Recruiting
    • Büşra Şirin · Contactbsrn080@gmail.com · 02124443322
    • Büşra Şirin Ahısha, MD · Principal investigator
    • Nurdan Paker, Prof · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Apr 2025, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2025
First posted
Mar 13, 2025
StartActual
Mar 10, 2025
Primary completionEst.
Apr 10, 2025
CompletionEst.
Apr 10, 2025
Last update
Mar 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06874816
Lead sponsor
Beylikduzu State Hospital
Responsible party
Busra Sirin (MD, Beylikduzu State Hospital) — Principal investigator
First posted
Mar 13, 2025
Start date
Mar 10, 2025
Primary completion
Apr 10, 2025 (estimated)
Completion
Apr 10, 2025 (estimated)
Last update
Mar 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion