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NCT Number: NCT07544108

Predictors of Functional Status in Chronic 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kütahya Health Sciences University, Kütahya City Hospital

Kütahya, 43020, Turkey (Türkiye)

Location status: Recruiting

Location contact

SEVAL TAMER

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assesment

Other

only single assessment

Primary outcomes

  1. 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

Other outcomes

  1. 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 .

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Predictors of Functional Status in Chronic Non-Spesific Neck Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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