Neck PainNCT06889220
Investigation of Related Factors in Patients With Non-Specific Neck Pain
An observational study of Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
It has been shown that there is a complex association between neck pain, temporomandibular joint dysfunctions, and migraines, and that these conditions can be influenced by factors such as depression, physical inactivity, and health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2025to 1 Sep 2025
- How long will I take part?
- 1 Week
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned that men and women diagnosed with non-specific neck pain between the ages of 18 and 70 will participate in the study.
Who may be able to join
- Being between the ages of 18 and 70
- Having non-specific neck pain
- Experiencing migraine-related headaches
Who cannot join
- Having a diagnosis of cervical trauma, surgery, or disc herniation
- Having a diagnosis of abnormal range of motion in the TMJ or cervical spine, scoliosis, or kyphosis
- Having neurological impairments
- Having systemic diseases
- Having dental or oral pathological lesions, oral infections, facial paralysis, or neuropathic facial pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Temporomandibular Disorder, Migraine, and Other Related Factors in Patients With Non-Specific Neck Pain
It has been shown that there is a complex association between neck pain, temporomandibular joint dysfunctions, and migraines, and that these conditions can be influenced by factors such as depression, physical inactivity, and health-related quality of life. Likewise, it is observed that all the factors within this complex structure can actually act as triggers, initiators, or intensifiers of each other.
In recent years, with a more detailed examination of their physiological connections, a reciprocal triangular relationship has been demonstrated between temporomandibular joint (TMJ) dysfunctions, headaches-especially migraines-and neck pain.
Read more
A detailed correlation of risk factors affecting neck pain-primarily temporomandibular joint involvement and headaches-in patients with neck pain will help identify underlying secondary effects and facilitate the inclusion of patient-centered, specific exercises in rehabilitation programs for these patients.
Studies in the literature indicate that the relationship between neck pain, temporomandibular joint dysfunctions, and migraines has not been evaluated collectively, and the impact of factors such as depression, physical inactivity, and health-related quality of life on these conditions has not been thoroughly assessed. Therefore, this study aims to comprehensively investigate the effects of temporomandibular joint dysfunctions, migraines, and other associated factors in individuals with non-specific neck pain.
- Conditions
- Neck Pain
- Keywords
- non-specific neck pain, temporamandibular joint dysfunction, migraine, Health-related quality of life (HRQoL), Depression
- Medical subject headings
- Neck Pain, Migraine Disorders, Depression
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 |
|---|---|---|
| People with non-specific neck pain | People with non-specific neck pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Neck Disability Index was first defined in 1991. It assesses disability associated with neck pain.
The index consists of a total of 10 sections, evaluating pain and limitations in activities such as pain, personal care, and lifting, with scores ranging from 0 to 5 for each section. The total score ranges from a minimum of 0 to a maximum of 50. Based on the total score, the classifications are as follows:
0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35 and above: Complete disability A validity and reliability study for the Turkish version is available.
Measured: Baseline
Migraine Disability Assessment
The Migraine Disability Assessment Scale (MIDAS) is one of the most commonly used scales for measuring headache-related disability. It assesses migraine-related functional impairment in all activities over the past three months.
The questionnaire consists of five questions:
Questions 1, 3, and 5 evaluate the number of days lost due to headaches in the past three months in work or school, household chores, and leisure activities.
Questions 2 and 4 assess the number of days with reduced productivity at work and in household activities due to headaches.
The total score is obtained by summing the responses (number of days) for all five questions. The classification based on the total score is as follows:
0-5 points: Grade I (No or minimal disability) 6-10 points: Grade II (Mild disability) 11-20 points: Grade III (Moderate disability) 21 and above: Grade IV (Severe disability) The Turkish validity and reliability study was conducted.
Measured: Baseline
Helkimo Clinical Dysfunction Index
The ındex was developed in 1974 and evaluates the overall functionality of the craniomandibular region along with TMJ function. It assesses five clinical findings, including:
- Mandibular range of motion 2. TMJ function 3. Pain during mandibular movements 4. TMJ pain on palpation 5. Muscle tenderness Each component is scored between 0 and 5.
- Assesses limitations in jaw movement, including maximum mouth opening, right and left lateral movements, and forward movement.
- component: Evaluates TMJ function by detecting deviations, sounds, and/or joint locking or blockages.
- component: Assesses the presence of pain during specific movements.
- component: Evaluates muscle pain in the chewing muscles.
- component: Assesses discomfort or pain in pre-articular TMJ region through palpation.
The total score is categorized as follows:
0 points: No signs or symptoms 1-4 points: Mild dysfunction 5-9 points: Moderate dysfunction 10-25 points: Severe dysfunction
Measured: Baseline
Secondary outcomes (3)
Short Form - 36
The questionnaire, developed to assess general health status and health-related quality of life, consists of 36 questions and evaluates eight subscales:
Physical function Physical role Emotional role Energy (vitality) Mental health Social function Pain General health The obtained data are scored between 0 and 100 for each subscale, with higher scores indicating better health status and improved quality of life.
The Turkish validity and reliability study was conducted.
Measured: Baseline
Beck Depression Inventory
Beck Depression Inventory, developed in 1961, is a 21-item scale assessing depressive symptoms such as pessimism, feelings of failure, lack of satisfaction, guilt, restlessness, fatigue, decreased appetite, indecisiveness, sleep disturbances, and social withdrawal. The validity and reliability study for the Turkish version was conducted in 1988.
Each item is scored using a four-point Likert scale (0-3), reflecting self-reported experiences of depression-related behaviors. The total score ranges from 0 to 63, with higher scores indicating greater depression severity.
Score interpretation:
- Below 10: No or minimal depression
- 10-18: Mild to moderate depression
- 19-29: Moderate to severe depression
- 30-63: Severe depression
Measured: Baseline
International Physical Activity Questionnaire (IPAQ)
The questionnaire consists of seven questions.
- The first two questions assess vigorous activities
- The third and fourth questions assess moderate-intensity activities
- The fifth and sixth questions assess walking
- The seventh question assesses time spent sitting in the past seven days Based on participants' responses, metabolic equivalent (MET) values are calculated and multiplied by the duration (in minutes and days) to determine the weekly MET-minute score.
The MET values for different activity levels are:
- Light activities: 3.3 MET
- Moderate-intensity activities: 4.0 MET
- Vigorous activities: 8.0 MET
Physical activity levels are classified as follows based on total MET-minutes per week:
- Inactive: less than 600 MET-min per week
- Low physical activity level: between 600 and 3000 MET-min per week
- Adequate physical activity level (health-beneficial): more than 3000 MET-min per week.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start19 Mar 2025
- Primary completion30 Apr 2025
- Study completion1 Sep 2025
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdi Kayabınar, Hacettepe University
- Investigators
- Erdi KAYABINAR, PhD, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889220
- Sponsor's protocol ID
- 2025/86
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Temporomandibular Disorder, Migraine, and Other Related Factors in Patients With Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT06889220
- Acronym / sponsor ID
- 2025/86
- Conditions
- Neck Pain
- Keywords
- non-specific neck pain, temporamandibular joint dysfunction, migraine, Health-related quality of life (HRQoL), Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 21 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.
It has been shown that there is a complex association between neck pain, temporomandibular joint dysfunctions, and migraines, and that these conditions can be influenced by factors such as depression, physical inactivity, and health-related quality of life. Likewise, it is observed that all the factors within this complex structure can actually act as triggers, initiators, or intensifiers of each other.
In recent years, with a more detailed examination of their physiological connections, a reciprocal triangular relationship has been demonstrated between temporomandibular joint (TMJ) dysfunctions, headaches-especially migraines-and neck pain.
A detailed correlation of risk factors affecting neck pain-primarily temporomandibular joint involvement and headaches-in patients with neck pain will help identify underlying secondary effects and facilitate the inclusion of patient-centered, specific exercises in rehabilitation programs for these patients.
Studies in the literature indicate that the relationship between neck pain, temporomandibular joint dysfunctions, and migraines has not been evaluated collectively, and the impact of factors such as depression, physical inactivity, and health-related quality of life on these conditions has not been thoroughly assessed. Therefore, this study aims to comprehensively investigate the effects of temporomandibular joint dysfunctions, migraines, and other associated factors in individuals with non-specific neck pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with non-specific neck pain | – | –People with non-specific neck pain |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned that men and women diagnosed with non-specific neck pain between the ages of 18 and 70 will participate in the study.
Key inclusion criteria (3 listed)
- Being between the ages of 18 and 70
- Having non-specific neck pain
- Experiencing migraine-related headaches
Key exclusion criteria (5 listed)
- Having a diagnosis of cervical trauma, surgery, or disc herniation
- Having a diagnosis of abnormal range of motion in the TMJ or cervical spine, scoliosis, or kyphosis
- Having neurological impairments
- Having systemic diseases
- Having dental or oral pathological lesions, oral infections, facial paralysis, or neuropathic facial pain
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 Disability Index
Time frame: Baseline
Neck Disability Index was first defined in 1991. It assesses disability associated with neck pain. The index consists of a total of 10 sections, evaluating pain and limitations in activities such as pain, personal care, and lifting, with scores ranging from 0 to 5 for each section. The total score ranges from a minimum of 0 to a maximum of 50. Based on the total score, the classifications are as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35 and above: Complete disability A validity and reliability study for the Turkish version is available.
Migraine Disability Assessment
Time frame: Baseline
The Migraine Disability Assessment Scale (MIDAS) is one of the most commonly used scales for measuring headache-related disability. It assesses migraine-related functional impairment in all activities over the past three months. The questionnaire consists of five questions: Questions 1, 3, and 5 evaluate the number of days lost due to headaches in the past three months in work or school, household chores, and leisure activities. Questions 2 and 4 assess the number of days with reduced productivity at work and in household activities due to headaches. The total score is obtained by summing the responses (number of days) for all five questions. The classification based on the total score is as follows: 0-5 points: Grade I (No or minimal disability) 6-10 points: Grade II (Mild disability) 11-20 points: Grade III (Moderate disability) 21 and above: Grade IV (Severe disability) The Turkish validity and reliability study was conducted.
Helkimo Clinical Dysfunction Index
Time frame: Baseline
The ındex was developed in 1974 and evaluates the overall functionality of the craniomandibular region along with TMJ function. It assesses five clinical findings, including: 1. Mandibular range of motion 2. TMJ function 3. Pain during mandibular movements 4. TMJ pain on palpation 5. Muscle tenderness Each component is scored between 0 and 5. 1. Assesses limitations in jaw movement, including maximum mouth opening, right and left lateral movements, and forward movement. 2. component: Evaluates TMJ function by detecting deviations, sounds, and/or joint locking or blockages. 3. component: Assesses the presence of pain during specific movements. 4. component: Evaluates muscle pain in the chewing muscles. 5. component: Assesses discomfort or pain in pre-articular TMJ region through palpation. The total score is categorized as follows: 0 points: No signs or symptoms 1-4 points: Mild dysfunction 5-9 points: Moderate dysfunction 10-25 points: Severe dysfunction
3 secondary outcomes
Short Form - 36
Time frame: Baseline
Beck Depression Inventory
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
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 9 Dec 2025.
- 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.
Erdi KAYABINAR, PhD principal investigator
University of Yalova
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 Hacettepe University 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 5 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 9 Dec 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?
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 Disability Index (time frame: Baseline). The study lists 3 primary outcomes in all. 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 9 Dec 2025.