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).
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
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.
- Conditions
- Neck Pain, Quality of Life
- 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.
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)
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
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
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
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
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
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
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.
- First posted16 Jan 2025
- Study start20 Dec 2024
- Primary completion3 Jun 2025 (estimated)
- Study completion13 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mensure Aslan, Kirsehir Ahi Evran Universitesi
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Affecting Quality of Life in Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT06777862
- Acronym / sponsor ID
- KAEU-M.ASLAN-001
- Conditions
- Neck Pain, Quality of Life
- Keywords
- chronic neck pain, quality of life, depression, proprioception, muscle strength
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 3 Jun 2025 (estimated)
- Study completion
- 13 Jul 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Those with any systemic disease
- Those with cervical pathology
- Previous surgery in the neck region
- Those with neuromuscular disease
- Those with rheumatology disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
RANGE OF MOTION
Time frame: 6 weeks
MUSCLE STRENGTH
Time frame: 6 weeks
Cervical Region Proprioception Sense
Time frame: 6 weeks
Depression symptoms
Time frame: 6 weeks
Quality of Life Level
Time frame: 6 weeks
Sleep Quality
Time frame: 6 weeks
Neck Disability Level
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.