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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
single group
single measurement
Other: assesment
only single assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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