Neck Pain ChronicNCT06946875
Factors Associated With Pain Threshold in Young Adults With Chronic Neck Pain
An observational study of Neck Pain Chronic, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Neck Pain Chronic
- What is being tested?
- Pain Threshold
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Aug 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young Adults with Chronic Neck Pain
Who may be able to join
- to be examined by specialised physicians and diagnosed with chronic neck pain
- to be physically and mentally fit to participate in the study.
Who cannot join
- the presence of instability in the neck joints,
- trauma within the last year,
- severe osteoporosis,
- previous neck surgery,
- physical therapy within the last 6 months,
- neurological findings or radiculopathy were determined.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kto Karatay Üniversitesi
Karatay, Konya, 42000
About this study
Official title: The Effect of Pain Intensity, Neck Disability, Anxiety, and Quality of Life on Pain Threshold in Young Adults With Chronic Neck Pain
The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.
Read the detailed description
This study aims to investigate the factors influencing treatment expectations in individuals suffering from chronic neck pain. Neck pain is a prevalent musculoskeletal disorder that significantly affects individuals' quality of life over long periods. It is recognized globally as the fourth leading cause of disability and imposes substantial economic burdens due to treatment costs, loss of workforce productivity, and healthcare expenditures.
Chronic neck pain often arises from nonspecific mechanical and postural causes, with various risk factors including socio-demographic (age, gender, genetics, obesity, occupation), psychological (stress, anxiety, depression, personality traits), and behavioral (postural disorders, prolonged sedentary work positions, smoking, physical activity habits) contributing to its development.
Pain duration classification categorizes neck pain as acute (up to six weeks), subacute (six weeks to three months), and chronic (over three months). The prevalence of chronic neck pain is increasing due to technological advancements and lifestyle changes, such as prolonged phone and computer use.
Psychological factors play a significant role in chronic neck pain, with high rates of depression and anxiety observed among affected individuals. These psychosocial factors, along with pain severity and disability, adversely impact patients' quality of life and pain threshold levels.
Despite extensive research, there is a lack of studies examining the combined effects of pain severity, neck disability, anxiety, and quality of life on pain threshold among young adults with chronic neck pain. This study seeks to fill this gap by exploring these relationships, aiming to contribute to the literature and support the development of a multidisciplinary approach to neck pain treatment.
- Conditions
- Neck Pain Chronic
- Being tested
- Pain Threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain ThresholdOther
The pain thresholds of the participants will be measured with an algometer device. With this device, the minimum pressure threshold that causes pain is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1-Chronic Neck Pain Group | All participants have chronic neck pain and will be evaluated observationally. Receives: Other: Pain Threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold
The pain thresholds of the participants will be measured with an algometer device. With this device, the minimum pressure threshold that causes pain is recorded. Algometer is used as a standard in pain and sensorial threshold measurements (24). Pain threshold measurements will be performed on the specified point in all patients. Measurements will be made with a 1 cm² disc head apparatus connected to a pressure device calibrated to kg/cm² in power unit. The patient will be instructed to give the 'stop' command at the first sensation of pain. The applied pressure will be increased until the patient first feels the pain. The measurement will be terminated with the patient's stop command. Measurements were made 3 times from the same point and their average will be taken.
The pressure pain threshold will be evaluated as the centre of the upper trapezius muscle.
Measured: Baseline
Secondary outcomes (4)
Visual Analogue Scale
The scale used in pain assessment, the Visual Analogue Scale, consists of a 10 cm horizontally positioned line on the page. The number '0', which is the starting point on this line, represents that the patient does not feel any pain, and the number '10' represents the worst pain experienced by the patient within their own experience. The patient is asked to mark any place he/she wants on this straight line between 0 and 10 in order to show the pain he/she has at the time the test is applied. Then, with the help of a ruler, the distance of the point marked by the patient to the starting point, the number 0, is measured and the value obtained is recorded.
Measured: Baseline
Neck Disability Index
The Neck Disability Index (NDI) consists of 10 items: pain intensity, personal care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. The individuals included in the study were asked to give a score between 0 (no disability) and 5 (full disability) for each item. For each answer option, A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points were calculated. The total score ranges from 0 (no disability) to 50 (full disability).
- 0-4: no disability 22
- 5-14: mild disability
- 15-24: moderate disability
- 25-34: severe disability
- 35-50: considered as totally disabled.
Measured: Baseline
Nottingham Health Profile
The Nottingham Health Profile is a 38-question general quality of life questionnaire developed to examine perceived health problems and the extent to which these problems affect activities of daily living. The questionnaire has a total of 6 sub-headings including 3 questions for energy level, 8 for pain, 9 for emotional reactions, 5 for sleep, 5 for social isolation and 8 for physical mobility. Each sub-heading is worth a total of 100 points and the value of each question is determined by dividing this value by the number of questions of the relevant section. A 'yes' answer to the questions is worth the score of the question, while a 'no' answer is worth zero points.
Measured: Baseline
Beck Anxiety Scale
The questions in the Beck anxiety scale are related to anxiety symptoms. In the scale consisting of 21 questions in total, each question has four options in total as 'none, mild, moderate, severe'. The evaluation of the questions is done by considering the last week. Turkish adaptation, validity and reliability studies were conducted
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain ChronicStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burcu DURSUN, Lecturer, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946875
- Sponsor's protocol ID
- KaratayUBD1
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Intensity, Neck Disability, Anxiety, and Quality of Life on Pain Threshold in Young Adults With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06946875
- Acronym / sponsor ID
- KaratayUBD1
- Conditions
- Neck Pain Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 Apr 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 aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.
Detailed description
This study aims to investigate the factors influencing treatment expectations in individuals suffering from chronic neck pain. Neck pain is a prevalent musculoskeletal disorder that significantly affects individuals' quality of life over long periods. It is recognized globally as the fourth leading cause of disability and imposes substantial economic burdens due to treatment costs, loss of workforce productivity, and healthcare expenditures.
Chronic neck pain often arises from nonspecific mechanical and postural causes, with various risk factors including socio-demographic (age, gender, genetics, obesity, occupation), psychological (stress, anxiety, depression, personality traits), and behavioral (postural disorders, prolonged sedentary work positions, smoking, physical activity habits) contributing to its development.
Pain duration classification categorizes neck pain as acute (up to six weeks), subacute (six weeks to three months), and chronic (over three months). The prevalence of chronic neck pain is increasing due to technological advancements and lifestyle changes, such as prolonged phone and computer use.
Psychological factors play a significant role in chronic neck pain, with high rates of depression and anxiety observed among affected individuals. These psychosocial factors, along with pain severity and disability, adversely impact patients' quality of life and pain threshold levels.
Despite extensive research, there is a lack of studies examining the combined effects of pain severity, neck disability, anxiety, and quality of life on pain threshold among young adults with chronic neck pain. This study seeks to fill this gap by exploring these relationships, aiming to contribute to the literature and support the development of a multidisciplinary approach to neck pain treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort1-Chronic Neck Pain Group | – | Other: Pain ThresholdAll participants have chronic neck pain and will be evaluated observationally. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young Adults with Chronic Neck Pain
Key inclusion criteria (2 listed)
- to be examined by specialised physicians and diagnosed with chronic neck pain
- to be physically and mentally fit to participate in the study.
Key exclusion criteria (6 listed)
- the presence of instability in the neck joints,
- trauma within the last year,
- severe osteoporosis,
- previous neck surgery,
- physical therapy within the last 6 months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain ThresholdThe pain thresholds of the participants will be measured with an algometer device. With this device, the minimum pressure threshold that causes pain is recorded. | Other | Cohort1-Chronic Neck Pain Group |
Primary outcome
Pain Threshold
Time frame: Baseline
The pain thresholds of the participants will be measured with an algometer device. With this device, the minimum pressure threshold that causes pain is recorded. Algometer is used as a standard in pain and sensorial threshold measurements (24). Pain threshold measurements will be performed on the specified point in all patients. Measurements will be made with a 1 cm² disc head apparatus connected to a pressure device calibrated to kg/cm² in power unit. The patient will be instructed to give the 'stop' command at the first sensation of pain. The applied pressure will be increased until the patient first feels the pain. The measurement will be terminated with the patient's stop command. Measurements were made 3 times from the same point and their average will be taken. The pressure pain threshold will be evaluated as the centre of the upper trapezius muscle.
4 secondary outcomes
Visual Analogue Scale
Time frame: Baseline
Neck Disability Index
Time frame: Baseline
Nottingham Health Profile
Time frame: Baseline
Beck Anxiety Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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. This study is not recruiting at the moment.
Burcu DURSUN, Lecturer principal investigator
KTO Karatay University
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 Chronic, run by KTO Karatay University 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 2 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: finished, as of the sponsor's last update on 6 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Threshold (time frame: Baseline). 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 6 Aug 2025.