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Enrolling by Invitation

NCT Number: NCT06777862

Chronic Non-Specific Neck Pain and Quality of Life

The factors affecting the quality of life in individuals with chronic non-specific neck pain are not fully known in the studies conducted to date. The aim of this study was to examine the factors affecting the quality of life of individuals with chronic non-specific neck pain.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kirsehir Ahi Evran University

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

No history of radicular pain, trauma or surgery in the cervical region,

  • Between the ages of 18-65,
  • Having neck pain for at least 6 months,
  • Not having received any treatment for neck pain in the last year
  • Volunteers with chronic non-specific neck pain

Exclusion criteria

  • Those with any systemic disease
  • Those with cervical pathology
  • Previous surgery in the neck region
  • Those with neuromuscular disease
  • Those with rheumatology disease
  • Infection

Treatment and study plan

Primary outcomes

  1. Pain Level

    Time frame: 6 weeks

    Visual Analog Scale (VAS) will be used to assess the severity of the patient's neck pain. The participant is asked to mark the severity of the pain on a 10-centimeter line (0=no pain, 10=very much pain)

Secondary outcomes

  1. RANGE OF MOTION

    Time frame: 6 weeks

    Clinical goniometer will be used to measure the flexion, extension, lateral flexion and rotation range of motion of the cervical spine.

  2. MUSCLE STRENGTH

    Time frame: 6 weeks

    In order to obtain objective data, maximal isometric muscle strength of the cervical region muscles will be measured with a Lafayette brand portable dynamometer. During the measurements, participants are asked to generate maximum force against the portable dynamometer device throughout the test (3-5 seconds).

  3. Cervical Region Proprioception Sense

    Time frame: 6 weeks

    Joint position sense will be evaluated in four directions: left rotation, right rotation, extension and flexion with the Cervical Joint Position Sense Test. A total of ten measurements will be made, the first four for trial purposes. The average of the last six measurements will be taken for each direction.

  4. Depression symptoms

    Time frame: 6 weeks

    Beck Depression Inventory (BDI) will be used to assess depression symptoms. The scale consists of 21 items, each of which is scored from 0 to 3. Higher scores indicate the severity of depression (1-10 points = normal, 11-16 points = moderate mood disturbance, 17-20 points = clinical depression, 21-30 points = moderate depression, 31-40 points = severe depression, 41-63 points = severe depression).

  5. Quality of Life Level

    Time frame: 6 weeks

    The participants' quality of life will be assessed with the Short Form Health Survey -36 Quality of Life Scale. The scale consists of 36 statements and has 8 subheadings (physical function, pain, mental status, physical role limitation, emotional role limitation, vitality, social function and general perception of health). As the total score increases, the quality of life also increases. Scores for these scales are standardized into values ranging from 0 to 100 with 50 representing average health.

  6. Sleep Quality

    Time frame: 6 weeks

    The participants' sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). The scale consists of seven components (subjective sleep quality, time it takes to fall asleep, sleep duration, sleep disorders, use of medication for sleep, habitual efficiency of sleep and daily life dysfunction). Each component is valued between 0-5 points. The total score is 0-21 points (<5 points = good sleep quality, >5 points disturbed sleep quality).

  7. Neck Disability Level

    Time frame: 6 weeks

    Neck Disability Questionnaire will be used to evaluate disability due to neck pain. The questionnaire consists of 10 questions. The questionnaire evaluates the intensity of pain in the neck region, difficulty in personal care and work, headache, pain level while reading, lifting performance, driving, difficulty level in sleeping and leisure activities. Each question is evaluated with 0-5 points and increasing score is associated with increasing disability. A high total score indicates that the individual's neck disability rate increases. (0-20 points = minimal disability, 21-40 points = moderate disability, 41-60 points = severe disability, 61-80 points = disability, 81-100 points = bedridden

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

Investigation of Factors Affecting Quality of Life in Chronic Non-Specific Neck Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

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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