Chronic Neck PainNCT07525557
Kinesiophobia, Pain and Disability in Chronic Neck Pain
An observational study of Chronic Neck Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the mediating role of kinesiophobia in the relationship between pain intensity and disability in individuals with chronic neck pain. Chronic neck pain is a multidimensional clinical condition influenced not only by biological factors but also by psychological components such as fear of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neck Pain
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic neck pain recruited voluntarily from outpatient clinics and community settings.
Who may be able to join
- Individuals aged 18 years or older
- Presence of chronic neck pain lasting at least 3 months
- Ability to understand and complete questionnaires
- Voluntary participation
Who cannot join
- Acute neck pain (< 3 months)
- History of cervical spine surgery
- Neurological disease or cervical radiculopathy
- Inflammatory, neoplastic, or traumatic conditions affecting the neck
- Cognitive impairment preventing questionnaire completion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Romatem Physical Therapy and Rehabilitation Hospital
Samsun, Samsun, 55080
About this study
Official title: Kinesiophobia As A Mediator Of The Association Between Pain Intensity And Disability In Chronic Neck Pain
This study aims to investigate the mediating role of kinesiophobia in the relationship between pain intensity and disability in individuals with chronic neck pain. Chronic neck pain is a multidimensional clinical condition influenced not only by biological factors but also by psychological components such as fear of movement. Understanding the mechanisms underlying disability may contribute to more targeted rehabilitation strategies. Participants with chronic neck pain lasting at least three months will be assessed using validated self-report questionnaires measuring pain intensity, kinesiophobia, disability, and physical activity levels.
Read the detailed description
Chronic neck pain is a common musculoskeletal disorder associated with significant functional limitations and reduced quality of life. While pain intensity is considered an important determinant of disability, it does not fully explain variations in functional outcomes among individuals. Psychological factors, particularly kinesiophobia, may influence the relationship between pain and disability through fear-avoidance mechanisms.
The purpose of this cross-sectional observational study is to examine whether kinesiophobia mediates the relationship between pain intensity and disability in individuals with chronic neck pain. Disability will be assessed in a multidimensional framework including neck-related and upper extremity functional limitations. Findings from this study may provide clinical implications for rehabilitation approaches targeting psychological components of chronic pain.
- Conditions
- Chronic Neck Pain
- Keywords
- Kinesiophobia, Chronic Pain, Musculoskeletal Pain, Disability Evaluation, Pain Measurement, Fear Avoidance, Neck Disability Index, Tampa Scale of Kinesiophobia
- Medical subject headings
- Kinesiophobia, Chronic Pain, Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Related Disability
Neck Disability Index (NDI)
Measured: Single assessment (baseline)
Pain Intensity
Numeric Pain Rating Scale (NPRS)
Measured: Baseline
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK)
Measured: Baseline
Deep cervical flexor muscle function
Craniocervical Flexion Test'in Performance Index (CCFT-PI)
Measured: Baseline
Physical Activity Level
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Apr 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MİNE PEKESEN KURTÇA, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525557
- Sponsor's protocol ID
- OMU2026/167
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia As A Mediator Of The Association Between Pain Intensity And Disability In Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT07525557
- Acronym / sponsor ID
- OMU2026/167
- Conditions
- Chronic Neck Pain
- Keywords
- Kinesiophobia, Chronic Pain, Musculoskeletal Pain, Disability Evaluation, Pain Measurement, Fear Avoidance, Neck Disability Index, Tampa Scale of Kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 13 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.
This study aims to investigate the mediating role of kinesiophobia in the relationship between pain intensity and disability in individuals with chronic neck pain. Chronic neck pain is a multidimensional clinical condition influenced not only by biological factors but also by psychological components such as fear of movement. Understanding the mechanisms underlying disability may contribute to more targeted rehabilitation strategies. Participants with chronic neck pain lasting at least three months will be assessed using validated self-report questionnaires measuring pain intensity, kinesiophobia, disability, and physical activity levels.
Detailed description
Chronic neck pain is a common musculoskeletal disorder associated with significant functional limitations and reduced quality of life. While pain intensity is considered an important determinant of disability, it does not fully explain variations in functional outcomes among individuals. Psychological factors, particularly kinesiophobia, may influence the relationship between pain and disability through fear-avoidance mechanisms.
The purpose of this cross-sectional observational study is to examine whether kinesiophobia mediates the relationship between pain intensity and disability in individuals with chronic neck pain. Disability will be assessed in a multidimensional framework including neck-related and upper extremity functional limitations. Findings from this study may provide clinical implications for rehabilitation approaches targeting psychological components of chronic pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic neck pain recruited voluntarily from outpatient clinics and community settings.
Key inclusion criteria (4 listed)
- Individuals aged 18 years or older
- Presence of chronic neck pain lasting at least 3 months
- Ability to understand and complete questionnaires
- Voluntary participation
Key exclusion criteria (5 listed)
- Acute neck pain (< 3 months)
- History of cervical spine surgery
- Neurological disease or cervical radiculopathy
- Inflammatory, neoplastic, or traumatic conditions affecting the neck
- Cognitive impairment preventing questionnaire completion
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
Pain-Related Disability
Time frame: Single assessment (baseline)
Neck Disability Index (NDI)
Pain Intensity
Time frame: Baseline
Numeric Pain Rating Scale (NPRS)
Kinesiophobia
Time frame: Baseline
Tampa Scale of Kinesiophobia (TSK)
Deep cervical flexor muscle function
Time frame: Baseline
Craniocervical Flexion Test'in Performance Index (CCFT-PI)
Physical Activity Level
Time frame: Baseline
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
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 4 Nov 2026.
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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 Chronic Neck Pain, run by Ondokuz Mayıs 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 4 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 4 Nov 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?
Pain-Related Disability (time frame: Single assessment (baseline)). The study lists 5 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 4 Nov 2026.