- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544108
Predictors of Functional Status in Chronic Neck Pain
April 22, 2026 updated by: Seval Tamer, Kutahya Health Sciences University
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: SEVAL TAMER
- Phone Number: +90 506 865 42 68
- Email: seval.tamer@ksbu.edu.tr
Study Locations
-
-
Kütahya
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Kütahya, Kütahya, Turkey (Türkiye), 43020
- Recruiting
- Kütahya Health Sciences University, Kütahya City Hospital
-
Contact:
- SEVAL TAMER
- Email: seval.tamer@ksbu.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Chronic neck pain
Description
Inclusion Criteria:
- patients aged 18-65
- patients have experienced non-specific neck pain for at least 3 months, patients who are literate, and no cognitive impairment.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
single group
single measurement
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only single assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1. day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
respiratory muscle strenght
Time Frame: 1. DAY
|
This will be assessed using a digital intraoral pressure measuring device (PowerBreathe KH2, UK).
While the individual is in a sitting position, using a nasal plug, the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measured.
During the MIP measurement, the individual is asked to perform maximum exhalation, and at the end, the airway is closed with a valve, and the person is asked to perform maximum inspiration and maintain it for 1-3 seconds.
After mıp endurance calculate.
In the MEP measurement, after the individual performs maximum inspiration, the airway is closed with a valve, and the individual is asked to perform maximum expiration against the airway for 1-3 seconds.
The best of the three measurements will be selected and recorded in cmH2O.
The recorded values will be calculated as percentages by referencing Black and Hyatt's equivalences for age, height, and gender and comparing them with expected values .
|
1. DAY
|
|
Pain assesment
Time Frame: 1. DAY
|
The severity of neck pain in patients will be assessed using a visual analog scale (VAS) whose reliability and validity have been established.
On a 10 cm long horizontal line, '0' will be marked as no pain and '10' as unbearable pain, and these will be measured and recorded with a ruler as cm
|
1. DAY
|
|
Kinesiophobia
Time Frame: 1. day
|
The Tampa Kinesiophobia Scale will be used to assess individuals' fear behaviors related to pain.
The questionnaire evaluates limitations in movement, re-injury, avoidance, and work-related activities due to fear with 17 questions.
In a total score of 17-68, high scores indicate high kinesiophobia.
|
1. day
|
|
Physical Activity level
Time Frame: 1 DAY
|
In the questionnaire, which consists of seven questions, the time and frequency spent in sitting, walking, moderate-to-vigorous activities, and vigorous activities will be asked, and the metabolic equivalent (MET) value will be calculated and recorded.
The total physical activity value will be determined using a formula calculated with the patient's body weight.
|
1 DAY
|
|
Depression level
Time Frame: 1 DAY
|
The Beck Depression Scale, a 21-item test, is used to assess the level of depression and differentiate depression from other psychopathological conditions.
In the questionnaire, which is evaluated with a score of 0-3 for each question, a score of 10-16 will be determined as mild, 17-29 as moderate, and 30-63 as severe depression.
|
1 DAY
|
|
Anxiety
Time Frame: 1. DAY
|
Beck Anxiety Scale; The anxiety level is assessed using a questionnaire consisting of 21 questions, with each question scored between 0-3.
A score of 0-17 indicates low anxiety, 18-24 indicates moderate anxiety, and 25 and above indicates high anxiety.
|
1. DAY
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2025
Primary Completion (Estimated)
April 20, 2026
Study Completion (Estimated)
June 20, 2026
Study Registration Dates
First Submitted
April 5, 2026
First Submitted That Met QC Criteria
April 19, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHSU-ST-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I can share it if requested.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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