PainobservationalNCT06583850
Chronic Neck Pain: Mobility, Sleep, Function
An observational study of Pain and Neck, run by Gamze Demircioğlu at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- The Neck Disability Index, Visual analog scale (VAS) and Pittsburgh Sleep Quality Index
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2024to 26 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Chronic neck pain and healthy controls
Who may be able to join
- Age between 18 and 55 years.
- Chronic neck pain (CNP) persisting for longer than 3 months (for the CNP group).
- Volunteering participation in the study.
- Healthy controls, including relatives of CNP participants.
Who cannot join
- History of neck trauma or other cervical spine conditions (e.g., radiculopathy).
- Prior surgical interventions involving the head, face, cervical spine, upper or lower extremities, or cervical disc herniation.
- Degenerative spinal conditions.
- Use of analgesics, anti-inflammatory medications, or muscle relaxants within the previous week.
- Presence of rheumatological or cardiovascular diseases, chronic neurological or psychiatric disorders, substance abuse, anemia, or diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain, Cervical Mobility, Sleep Quality and Functional Status in Individuals with Chronic Neck Pain
The goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. The study focuses on understanding the complex relationships between these factors in individuals with CNP, with the aim of providing insights that could contribute to more effective rehabilitation strategies.
The main questions it aims to answer are:
- How pain, cervical mobility, sleep quality, and functional status differs between individuals with and without chronic neck pain?
- What is the relationship between functional status and cervical mobility and sleep quality in individuals with chronic neck pain?
- Being tested
- The Neck Disability Index, Visual analog scale (VAS), Pittsburgh Sleep Quality Index, Cervical Range of Motion Assessment
- Keywords
- pain, neck, range of motion, sleep quality, functional status
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Neck Disability IndexOther
The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person\'s functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability.
Visual analog scale (VAS)Other
A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain. Participants were asked to mark a point between 0-10 according to their pain status
Pittsburgh Sleep Quality IndexOther
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire
Cervical Range of Motion AssessmentOther
Active Cervical Range Of Motion was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane).
| Study group | Role | What they receive |
|---|---|---|
| chronic neck pain | chronic neck pain (CNP) (persists longer than 3 months. Receives: Other: The Neck Disability Index; Other: Visual analog scale (VAS); Other: Pittsburgh Sleep Quality Index; Other: Cervical Range of Motion Assessment | |
| control | healthy controls Receives: Other: The Neck Disability Index; Other: Visual analog scale (VAS); Other: Pittsburgh Sleep Quality Index; Other: Cervical Range of Motion Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Neck Disability Index
The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability.
Measured: Baseline
Pittsburgh Sleep Quality
Five questions on the scale are answered by the participant\'s partner or roommate and are used solely for clinical information..The PSQI has seven components: subjective sleep quality, sleep latency, total sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score is calculated by summing the scores of the seven components, ranging from 0 to 21 points.
Measured: Baseline
Visual analog scale
A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain.
Measured: Baseline
Range of motion
Active Cervical Range of Motion Assessment was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane). The same physiotherapist performed all goniometric measurements to eliminate any differences between the measurements that the measurer could cause. The American Association of Orthopaedic Surgeons (AAOS) values were taken as a reference for NEH in the cervical region. Care was taken to ensure that the participant wore comfortable clothes during the measurements. Before starting the measurement, the desired movement was shown to the participant by the physiotherapist.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start5 Jun 2024
- Primary completion4 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze Demircioğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gamze Demircioğlu, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583850
- Sponsor's protocol ID
- neckpain
- Acronym
- observational
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain, Cervical Mobility, Sleep Quality and Functional Status in Individuals with Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06583850
- Acronym / sponsor ID
- observational / neckpain
- Keywords
- pain, neck, range of motion, sleep quality, functional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Gamze DemircioğluUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 4 Sep 2024 (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 goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. The study focuses on understanding the complex relationships between these factors in individuals with CNP, with the aim of providing insights that could contribute to more effective rehabilitation strategies.
The main questions it aims to answer are:
- How pain, cervical mobility, sleep quality, and functional status differs between individuals with and without chronic neck pain?
- What is the relationship between functional status and cervical mobility and sleep quality in individuals with chronic neck pain?
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic neck pain | – | Other: The Neck Disability Index, Other: Visual analog scale (VAS), Other: Pittsburgh Sleep Quality Index, Other: Cervical Range of Motion Assessmentchronic neck pain (CNP) (persists longer than 3 months. |
| control | – | Other: The Neck Disability Index, Other: Visual analog scale (VAS), Other: Pittsburgh Sleep Quality Index, Other: Cervical Range of Motion Assessmenthealthy controls |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chronic neck pain and healthy controls
Key inclusion criteria (4 listed)
- Age between 18 and 55 years.
- Chronic neck pain (CNP) persisting for longer than 3 months (for the CNP group).
- Volunteering participation in the study.
- Healthy controls, including relatives of CNP participants.
Key exclusion criteria (5 listed)
- History of neck trauma or other cervical spine conditions (e.g., radiculopathy).
- Prior surgical interventions involving the head, face, cervical spine, upper or lower extremities, or cervical disc herniation.
- Degenerative spinal conditions.
- Use of analgesics, anti-inflammatory medications, or muscle relaxants within the previous week.
- Presence of rheumatological or cardiovascular diseases, chronic neurological or psychiatric disorders, substance abuse, anemia, or diabetes.
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 |
|---|---|---|
| The Neck Disability IndexThe Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person\'s functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability. | Other | chronic neck pain, control |
| Visual analog scale (VAS)A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain. Participants were asked to mark a point between 0-10 according to their pain status | Other | chronic neck pain, control |
| Pittsburgh Sleep Quality IndexSleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire | Other | chronic neck pain, control |
| Cervical Range of Motion AssessmentActive Cervical Range Of Motion was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane). | Other | chronic neck pain, control |
Primary outcome
The Neck Disability Index
Time frame: Baseline
The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability.
Pittsburgh Sleep Quality
Time frame: Baseline
Five questions on the scale are answered by the participant\'s partner or roommate and are used solely for clinical information..The PSQI has seven components: subjective sleep quality, sleep latency, total sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score is calculated by summing the scores of the seven components, ranging from 0 to 21 points.
Visual analog scale
Time frame: Baseline
A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain.
Range of motion
Time frame: Baseline
Active Cervical Range of Motion Assessment was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane). The same physiotherapist performed all goniometric measurements to eliminate any differences between the measurements that the measurer could cause. The American Association of Orthopaedic Surgeons (AAOS) values were taken as a reference for NEH in the cervical region. Care was taken to ensure that the participant wore comfortable clothes during the measurements. Before starting the measurement, the desired movement was shown to the participant by the physiotherapist.
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 27 Sep 2024.
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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.
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 Pain and Neck, run by Gamze Demircioğlu 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 4 inclusion and 5 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 27 Sep 2024. 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?
The Neck Disability Index (time frame: Baseline). The study lists 4 primary outcomes in all. 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 27 Sep 2024.