Neck PainNCT04900870
Evaluation of the Relationship Between Neck Pain and Temporomandibular Disorders in Office Workers
An observational study of Neck Pain and Temporomandibular Disorder, run by Tugba Sahbaz at 1 site in Turkey (Türkiye).
Trial summary
The current study aimed to explore the associations between neck pain and temporomandibular disorders in office workers Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain, Temporomandibular Disorder
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2021to 20 Jul 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: aged between 18 and 55, working on computer, having neck pain at least three months with or without temporomandibular pain
Who may be able to join
- Aged between 18 and 55,
- Working on computer,
- Having neck pain at least three months.
Who cannot join
- Reporting pregnancy,
- Having a history of accidents,
- Trauma or surgery in the neck region and temporomandibular region,
- Congenital anomaly of the spine or temporomandibular joint,
- Rheumatologic disease,
- Osteoporosis,
Show all 11Show fewer
- Spondylosis,
- Spondylolisthesis,
- Infection of the spine or temporomandibular joint
- Cervical disc herniation,
- Tumor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital,
Istanbul, Kucukcekmece
About this study
The current study aimed to explore the associations between neck pain and temporomandibular disorders in office workers
Read the detailed description
This is a cross-sectional study. All participants will provide informed consent before participating in the study. The study will be conducted in accordance with the Helsinki Declaration criteria. Data will be collected using questionnaires, which include information on demographic, clinical conditions.
- Conditions
- Neck Pain, Temporomandibular Disorder
- Keywords
- neck pain, temporomandibular disorder, office workers
- Medical subject headings
- Neck Pain, Temporomandibular Joint Disorders
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 | Diagnostic Test: A self-administered questionnaire A self-administered questionnaire will be used to screen VAS scores, bournemouth neck questionnaire, demographic information and for temporomandibular pain Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments Axis I TMD Pain Screener, Symptom questionnaire and Axis II PHQ-4, Oral Behaviors Checklist . | |
| Neck pain with temeporomandibular pain | Diagnostic Test: A self-administered questionnaire A self-administered questionnaire will be used to screen VAS scores, bournemouth neck questionnaire, demographic information and for temporomandibular pain Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments Axis I TMD Pain Screener, Symptom questionnaire, Clinical Examination Form, Axis II Pain Drawing Graded Chronic Pain (version 2), JFLS-8 ,PHQ-4 Oral Behaviors Checklist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Bournemouth Questionnaire
The NBQ consists of 7 questions that examine the pain intensity, daily life activities, social activities, anxiety, emotional aspects of depression, kinesiophobia, and the ability to control pain. The items in the questionnaire are specific to patients with neck pain and each question evaluates a different parameter.The score for each measure are added. This can produce a value between a minimum score of 0, and a maximum score of 70. The higher the score reflects the degree of impact on a patient's life.
Measured: 1 interview day
Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) is a dual-axis framework for the assessment and diagnosis of Axis I physical diagnoses for the most common TMDs and Axis II self-report psychosocial and behavioral screening questionnaires.
Measured: 1 interview day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start20 May 2021
- Primary completion20 Jun 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 500 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tugba Sahbaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tugba Sahbaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Tugba Sahbaz, MD, Principal investigator, University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900870
- Sponsor's protocol ID
- KAEK/2021.03.114
- Status last verified
- Nov 2021
- First submitted
- 20 May 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Selms MKA, Wiegers JW, van der Meer HA, Ahlberg J, Lobbezoo F, Visscher CM. Temporomandibular disorders, pain in the neck and shoulder area, and headache among musicians. J Oral Rehabil. 2020 Feb;47(2):132-142. doi: 10.1111/joor.12886. Epub 2019 Sep 24.
PubMed 31520546Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Kang JH. Effects on migraine, neck pain, and head and neck posture, of temporomandibular disorder treatment: Study of a retrospective cohort. Arch Oral Biol. 2020 Jun;114:104718. doi: 10.1016/j.archoralbio.2020.104718. Epub 2020 Apr 18.
PubMed 32334135Visscher CM, Schouten MJ, Ligthart L, van Houtem CM, de Jongh A, Boomsma DI. Shared Genetics of Temporomandibular Disorder Pain and Neck Pain: Results of a Twin Study. J Oral Facial Pain Headache. 2018 Spring;32(2):107-112. doi: 10.11607/ofph.2016. Epub 2018 Mar 6.
PubMed 29509827Sahbaz T, Cigdem-Karacay B, Medin-Ceylan C, Korkmaz MD, Asik HK. The impact of self-reported temporomandibular pain on neck disability in office workers. J Back Musculoskelet Rehabil. 2025 Jul;38(4):774-782. doi: 10.1177/10538127251315829. Epub 2025 Mar 25.
PubMed 40129394
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Neck Pain and Temporomandibular Disorders in Office Workers
- ClinicalTrials.gov ID
- NCT04900870
- Acronym / sponsor ID
- KAEK/2021.03.114
- Conditions
- Neck Pain, Temporomandibular Disorder
- Keywords
- neck pain, temporomandibular disorder, office workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Tugba SahbazUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 25 May 2021 (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.
The current study aimed to explore the associations between neck pain and temporomandibular disorders in office workers
Detailed description
This is a cross-sectional study. All participants will provide informed consent before participating in the study. The study will be conducted in accordance with the Helsinki Declaration criteria. Data will be collected using questionnaires, which include information on demographic, clinical conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck pain | – | –Diagnostic Test: A self-administered questionnaire A self-administered questionnaire will be used to screen VAS scores, bournemouth neck questionnaire, demographic information and for temporomandibular pain Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments Axis I TMD Pain Screener, Symptom questionnaire and Axis II PHQ-4, Oral Behaviors Checklist . |
| Neck pain with temeporomandibular pain | – | –Diagnostic Test: A self-administered questionnaire A self-administered questionnaire will be used to screen VAS scores, bournemouth neck questionnaire, demographic information and for temporomandibular pain Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments Axis I TMD Pain Screener, Symptom questionnaire, Clinical Examination Form, Axis II Pain Drawing Graded Chronic Pain (version 2), JFLS-8 ,PHQ-4 Oral Behaviors Checklist. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- aged between 18 and 55, working on computer, having neck pain at least three months with or without temporomandibular pain
Key inclusion criteria (3 listed)
- Aged between 18 and 55,
- Working on computer,
- Having neck pain at least three months.
Key exclusion criteria (11 listed)
- Reporting pregnancy,
- Having a history of accidents,
- Trauma or surgery in the neck region and temporomandibular region,
- Congenital anomaly of the spine or temporomandibular joint,
- Rheumatologic disease,
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
Neck Bournemouth Questionnaire
Time frame: 1 interview day
The NBQ consists of 7 questions that examine the pain intensity, daily life activities, social activities, anxiety, emotional aspects of depression, kinesiophobia, and the ability to control pain. The items in the questionnaire are specific to patients with neck pain and each question evaluates a different parameter.The score for each measure are added. This can produce a value between a minimum score of 0, and a maximum score of 70. The higher the score reflects the degree of impact on a patient's life.
Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments
Time frame: 1 interview day
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) is a dual-axis framework for the assessment and diagnosis of Axis I physical diagnoses for the most common TMDs and Axis II self-report psychosocial and behavioral screening questionnaires.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 31520546van Selms MKA, Wiegers JW, van der Meer HA, Ahlberg J, Lobbezoo F, Visscher CM. Temporomandibular disorders, pain in the neck and shoulder area, and headache among musicians. J Oral Rehabil. 2020 Feb;47(2):132-142. doi: 10.1111/joor.12886. Epub 2019 Sep 24.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 32334135Kang JH. Effects on migraine, neck pain, and head and neck posture, of temporomandibular disorder treatment: Study of a retrospective cohort. Arch Oral Biol. 2020 Jun;114:104718. doi: 10.1016/j.archoralbio.2020.104718. Epub 2020 Apr 18.
- Background: PubMed 29509827Visscher CM, Schouten MJ, Ligthart L, van Houtem CM, de Jongh A, Boomsma DI. Shared Genetics of Temporomandibular Disorder Pain and Neck Pain: Results of a Twin Study. J Oral Facial Pain Headache. 2018 Spring;32(2):107-112. doi: 10.11607/ofph.2016. Epub 2018 Mar 6.
- Derived from this study: PubMed 40129394Sahbaz T, Cigdem-Karacay B, Medin-Ceylan C, Korkmaz MD, Asik HK. The impact of self-reported temporomandibular pain on neck disability in office workers. J Back Musculoskelet Rehabil. 2025 Jul;38(4):774-782. doi: 10.1177/10538127251315829. Epub 2025 Mar 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tugba Sahbaz, MD principal investigator
University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital
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 and Temporomandibular Disorder, run by Tugba Sahbaz 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: finished, as of the sponsor's last update on 10 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Bournemouth Questionnaire (time frame: 1 interview day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900870, which also lists 5 linked publications.
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 10 Nov 2021.