Neck PainNCT07544108
Predictors of Functional Status in Chronic Neck Pain
An observational study of Neck Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Although it has been reported that these problems seen together with neck pain are related to functional limitations and disability, there is still insufficient evidence regarding the relationship between factors affecting functional status and chronic neck pain symptoms in individuals with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- assesment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2025to 20 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Chronic neck pain
Who may be able to join
- patients aged 18-65
- patients have experienced non-specific neck pain for at least 3 months, patients who are literate, and no cognitive impairment.
Who cannot join
- patients with serious and secondary musculoskeletal diseases (inflammatory, neuropathic and malignancy)
- patiens who have undergone spinal and abdominal surgery and trauma
- patients who smoke
- patients if any lung disease that will affect respiration,
- patients with a body mass index greater than 40
- patients who cannot operate.
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
Kütahya Health Sciences University, Kütahya City Hospital
Kütahya, Kütahya, 43020
SEVAL TAMER, seval.tamer@ksbu.edu.tr
About this study
Official title: Predictors of Functional Status in Chronic Non-Spesific Neck Pain
Although it has been reported that these problems seen together with neck pain are related to functional limitations and disability, there is still insufficient evidence regarding the relationship between factors affecting functional status and chronic neck pain symptoms in individuals with chronic neck pain. Furthermore, a mixed methodology approach has not been used to comprehensively investigate this relationship. Identifying factors affecting functional status in CNP will help guide the prevention, treatment, and management of neck pain. Therefore, the aim of this study is to investigate the relationships between functional status and psychosocial and bodily functions in CNP.
Read the detailed description
In chronic neck pain , many body structures and problem joint movement restrictions, especially decreased strength and endurance of deep neck muscles, increased activation of superficial muscles such as scalene muscles, sternocleidomastoid muscles and impaired coordination between deep and superficial neck flexor muscles, decreased motor control and proprioception, postural problems, and many psychosocial problems such as stress, anxiety and depression, sleep problems, pain catastrophe, and fear-avoidance reactions. These symptoms in neck pain can also increase susceptibility to respiratory dysfunctions. Although it has been reported that these problems seen together with neck pain are related to functional limitations and disability, there is still insufficient evidence regarding the relationship between factors affecting functional status and symptoms of chronic neck pain in individuals with chronic neck pain.
- Conditions
- Neck Pain
- Being tested
- assesment
- Keywords
- Chronic neck pain, neck disability, maximum inspiratory pressure, maximum expiratory pressure, anxiety
- Medical subject headings
- Neck Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesmentOther
only single assessment
| Study group | Role | What they receive |
|---|---|---|
| single group | single measurement Receives: Other: assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NDI
ın the questionnaire, whose Turkish validity and reliability were established by Aslan , subjective symptoms (pain, headache, concentration, sleep) and daily living activities (personal care, carrying, reading, work, driving and recreation activities) are evaluated with a 6-option answer. Each option is scored with a value between 0 (no limitation) and 5 (maximum limitation), and 0-4 points are recorded as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe and 35-50 points as complete functional disability
Measured: 1. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Oct 2025
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Tamer, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544108
- Sponsor's protocol ID
- KHSU-ST-02
- Status last verified
- Oct 2025
- First submitted
- 5 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I can share it if requested.
Publications
Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Respiratory dysfunction in patients with chronic neck pain: What is the current evidence? J Bodyw Mov Ther. 2016 Oct;20(4):704-714. doi: 10.1016/j.jbmt.2016.02.001. Epub 2016 Feb 8.
PubMed 27814848
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Functional Status in Chronic Non-Spesific Neck Pain
- ClinicalTrials.gov ID
- NCT07544108
- Acronym / sponsor ID
- KHSU-ST-02
- Conditions
- Neck Pain
- Keywords
- Chronic neck pain, neck disability, maximum inspiratory pressure, maximum expiratory pressure, anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 22 Apr 2026 (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.
Although it has been reported that these problems seen together with neck pain are related to functional limitations and disability, there is still insufficient evidence regarding the relationship between factors affecting functional status and chronic neck pain symptoms in individuals with chronic neck pain. Furthermore, a mixed methodology approach has not been used to comprehensively investigate this relationship. Identifying factors affecting functional status in CNP will help guide the prevention, treatment, and management of neck pain. Therefore, the aim of this study is to investigate the relationships between functional status and psychosocial and bodily functions in CNP.
Detailed description
In chronic neck pain , many body structures and problem joint movement restrictions, especially decreased strength and endurance of deep neck muscles, increased activation of superficial muscles such as scalene muscles, sternocleidomastoid muscles and impaired coordination between deep and superficial neck flexor muscles, decreased motor control and proprioception, postural problems, and many psychosocial problems such as stress, anxiety and depression, sleep problems, pain catastrophe, and fear-avoidance reactions. These symptoms in neck pain can also increase susceptibility to respiratory dysfunctions. Although it has been reported that these problems seen together with neck pain are related to functional limitations and disability, there is still insufficient evidence regarding the relationship between factors affecting functional status and symptoms of chronic neck pain in individuals with chronic neck pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | – | Other: assesmentsingle measurement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic neck pain
Key inclusion criteria (2 listed)
- patients aged 18-65
- patients have experienced non-specific neck pain for at least 3 months, patients who are literate, and no cognitive impairment.
Key exclusion criteria (6 listed)
- patients with serious and secondary musculoskeletal diseases (inflammatory, neuropathic and malignancy)
- patiens who have undergone spinal and abdominal surgery and trauma
- patients who smoke
- patients if any lung disease that will affect respiration,
- patients with a body mass index greater than 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assesmentonly single assessment | Other | single group |
Primary outcome
NDI
Time frame: 1. day
ın the questionnaire, whose Turkish validity and reliability were established by Aslan , subjective symptoms (pain, headache, concentration, sleep) and daily living activities (personal care, carrying, reading, work, driving and recreation activities) are evaluated with a 6-option answer. Each option is scored with a value between 0 (no limitation) and 5 (maximum limitation), and 0-4 points are recorded as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe and 35-50 points as complete functional disability
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 27 Apr 2026.
- Background: PubMed 27814848Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Respiratory dysfunction in patients with chronic neck pain: What is the current evidence? J Bodyw Mov Ther. 2016 Oct;20(4):704-714. doi: 10.1016/j.jbmt.2016.02.001. Epub 2016 Feb 8.
- Individual participant dataSharing planned: Undecided. I can share it if requested.
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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 Kutahya Health Sciences 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 2 inclusion and 6 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 27 Apr 2026. 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?
Contact SEVAL TAMER (+90 506 865 42 68, seval.tamer@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NDI (time frame: 1. day). 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 NCT07544108, which also lists 1 linked publication.
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 27 Apr 2026.