Neck PainNCT07215819
Cervical Sagittal Alignment and Clinical Outcomes in Chronic Neck Pain
An observational study of Neck Pain and Body Awareness, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
This observational, cross-sectional study investigates the relationship between cervical sagittal alignment parameters, pain-related disability, and body awareness in patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain, Body Awareness, Neck Disability
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2025to 20 Nov 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18-60 years with chronic neck pain of at least 3 months' duration will be recruited. Eligible participants must have undergone lateral cervical X-ray imaging within the past 3 months. Both male and female participants will be included. Exclusion criteria are: prior history of cervical trauma or surgery; cervical radiculopathy or previous cervical spine operations; systemic conditions such as diabetes mellitus, inflammatory rheumatic disease, familial hyperlipidemia, malignancy, or fibromyalgia; and presence of known neurological or psychiatric disorders.
Who may be able to join
- Adults aged 18-600 years (inclusive), women and men
- Chronic neck pain ≥3 months in duration
- Lateral cervical X-ray performed within the past 3 months
Who cannot join
- History of cervical spine trauma or surgery
- Cervical radiculopathy (history or current radicular neck/arm pain)
- Systemic conditions: diabetes mellitus, inflammatory rheumatic disease, familial hyperlipidemia, malignancy, or fibromyalgia
- Known neurological or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Istanbul
About this study
Official title: Cervical Sagittal Alignment and Its Association With Disability and Neck Awareness in Patients With Chronic Neck Pain
This observational, cross-sectional study investigates the relationship between cervical sagittal alignment parameters, pain-related disability, and body awareness in patients with chronic neck pain. Adult patients aged 18-50 years who present with neck pain lasting at least 3 months and who have undergone a lateral cervical X-ray within the past 3 months will be included. Cervical sagittal parameters will be measured on radiographs, and participants will complete the Neck Disability Index (NDI) and the Fremantle Neck Awareness Questionnaire to evaluate disability and altered body perception.
Read the detailed description
Chronic neck pain is a common musculoskeletal problem associated with significant disability and reduced quality of life. Although structural and radiological parameters such as cervical sagittal alignment have been proposed as potential contributors to symptom severity, their association with clinical outcomes remains controversial. Altered body awareness, as assessed by the Fremantle Neck Awareness Questionnaire, represents an additional dimension that may influence symptom persistence and disability in these patients.
The aim of this study is to analyze the relationship between cervical sagittal alignment parameters, pain intensity, disability, and body awareness in patients with chronic neck pain. Eligible participants are adults aged 18-50 years with persistent neck pain for at least three months and who have undergone a lateral cervical X-ray within the last three months. Exclusion criteria include a history of cervical trauma or surgery, neurological or psychiatric disorders, inflammatory or systemic diseases, and conditions such as fibromyalgia or malignancy.
Pain intensity will be assessed using the Visual Analog Scale (VAS), disability with the Neck Disability Index (NDI), and body perception with the Fremantle Neck Awareness Questionnaire. Cervical sagittal alignment parameters will be measured retrospectively from the hospital's PACS system. By correlating radiographic findings with patient-reported outcomes, this study seeks to clarify the clinical relevance of cervical sagittal alignment and provide insight into its potential role in the management of chronic neck pain
- Conditions
- Neck Pain, Body Awareness, Neck Disability
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
Measured: At baseline
Fremantle Neck Awareness Questionnaire (FreNAQ-Neck)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start17 Feb 2025
- Primary completion11 Jun 2025
- Study completion20 Nov 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.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ekici Zincirci, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215819
- Sponsor's protocol ID
- Neck Pain
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Only aggregated and anonymized results will be disseminated through scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Sagittal Alignment and Its Association With Disability and Neck Awareness in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT07215819
- Acronym / sponsor ID
- Neck Pain
- Conditions
- Neck Pain, Body Awareness, Neck Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 14 Oct 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.
This observational, cross-sectional study investigates the relationship between cervical sagittal alignment parameters, pain-related disability, and body awareness in patients with chronic neck pain. Adult patients aged 18-50 years who present with neck pain lasting at least 3 months and who have undergone a lateral cervical X-ray within the past 3 months will be included. Cervical sagittal parameters will be measured on radiographs, and participants will complete the Neck Disability Index (NDI) and the Fremantle Neck Awareness Questionnaire to evaluate disability and altered body perception.
Detailed description
Chronic neck pain is a common musculoskeletal problem associated with significant disability and reduced quality of life. Although structural and radiological parameters such as cervical sagittal alignment have been proposed as potential contributors to symptom severity, their association with clinical outcomes remains controversial. Altered body awareness, as assessed by the Fremantle Neck Awareness Questionnaire, represents an additional dimension that may influence symptom persistence and disability in these patients.
The aim of this study is to analyze the relationship between cervical sagittal alignment parameters, pain intensity, disability, and body awareness in patients with chronic neck pain. Eligible participants are adults aged 18-50 years with persistent neck pain for at least three months and who have undergone a lateral cervical X-ray within the last three months. Exclusion criteria include a history of cervical trauma or surgery, neurological or psychiatric disorders, inflammatory or systemic diseases, and conditions such as fibromyalgia or malignancy.
Pain intensity will be assessed using the Visual Analog Scale (VAS), disability with the Neck Disability Index (NDI), and body perception with the Fremantle Neck Awareness Questionnaire. Cervical sagittal alignment parameters will be measured retrospectively from the hospital's PACS system. By correlating radiographic findings with patient-reported outcomes, this study seeks to clarify the clinical relevance of cervical sagittal alignment and provide insight into its potential role in the management of chronic neck pain
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck Pain Group | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18-60 years with chronic neck pain of at least 3 months' duration will be recruited. Eligible participants must have undergone lateral cervical X-ray imaging within the past 3 months. Both male and female participants will be included. Exclusion criteria are: prior history of cervical trauma or surgery; cervical radiculopathy or previous cervical spine operations; systemic conditions such as diabetes mellitus, inflammatory rheumatic disease, familial hyperlipidemia, malignancy, or fibromyalgia; and presence of known neurological or psychiatric disorders.
Key inclusion criteria (3 listed)
- Adults aged 18-600 years (inclusive), women and men
- Chronic neck pain ≥3 months in duration
- Lateral cervical X-ray performed within the past 3 months
Key exclusion criteria (4 listed)
- History of cervical spine trauma or surgery
- Cervical radiculopathy (history or current radicular neck/arm pain)
- Systemic conditions: diabetes mellitus, inflammatory rheumatic disease, familial hyperlipidemia, malignancy, or fibromyalgia
- Known neurological or psychiatric disorders
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 (NDI)
Time frame: At baseline
Fremantle Neck Awareness Questionnaire (FreNAQ-Neck)
Time frame: At 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 19 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Only aggregated and anonymized results will be disseminated through scientific publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Body Awareness, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 4 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 19 Mar 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?
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 (NDI) (time frame: At baseline). 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?
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 19 Mar 2026.