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Neck PainNCT06777862

Chronic Non-Specific Neck Pain and Quality of Life

An observational study of Neck Pain and Quality of Life, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Neck Pain, Quality of Life
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Dec 2024to 13 Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The sample of this study consists of individuals who applied to the Kırşehir Ahi Evran University Physical Medicine and Rehabilitation Polyclinic in Kırşehir province with complaints of neck pain and were diagnosed with chronic non-specific neck pain by specialist physicians.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Kirsehir Ahi Evran University

    Kırşehir, Merkez, 40100

Other trials in Turkey (Türkiye)

About this study

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

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.

Keywords
chronic neck pain, quality of life, depression, proprioception, muscle strength
Medical subject headings
Neck Pain, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Level

    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)

    Measured: 6 weeks

Secondary outcomes (7)
  1. RANGE OF MOTION

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

    Measured: 6 weeks

  2. MUSCLE STRENGTH

    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).

    Measured: 6 weeks

  3. Cervical Region Proprioception Sense

    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.

    Measured: 6 weeks

  4. Depression symptoms

    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).

    Measured: 6 weeks

  5. Quality of Life Level

    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.

    Measured: 6 weeks

  6. Sleep Quality

    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).

    Measured: 6 weeks

  7. Neck Disability Level

    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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start20 Dec 2024
  3. Primary completion3 Jun 2025 (estimated)
  4. Study completion13 Jul 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06777862
Sponsor's protocol ID
KAEU-M.ASLAN-001
Status last verified
Jan 2025
First submitted
6 Jan 2025
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain and Quality of Life, run by Kirsehir Ahi Evran Universitesi 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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 16 Jan 2025. 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?

This study is still under way. Results are not available in the source record yet.

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 Level (time frame: 6 weeks). 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 16 Jan 2025.

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