Neck PainNCT06976398
Chronic Neck Pain and Central Sensizitation
An observational study of Neck Pain, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Chronic neck pain is one of the musculoskeletal pain problems that can cause chronic disability. It is emphasised that individuals with chronic neck pain have difficulty during different activities in their daily lives, and that this problem is a very common health problem that can lead to disability. 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
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 15 Sep 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic non-specific neck pain will be included.
Who may be able to join
- Being between the ages of 18-65
- Being diagnosed with chronic non-specific neck pain by a doctor
- Being willing to participate in the study
Who cannot join
- Having psychological disorders, mental disorders, cancer and severe depression
- Having a history of traumatic injury
- Having a history of primary or metastatic spinal malignancy, spinal fracture
- Having a neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
- Having been diagnosed with advanced osteoporosis
- Having a history of surgical intervention or acute infection in the cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Central Sensitisation in Patients With Chronic Non-spesific Neck Pain
Chronic neck pain is one of the musculoskeletal pain problems that can cause chronic disability. It is emphasised that individuals with chronic neck pain have difficulty during different activities in their daily lives, and that this problem is a very common health problem that can lead to disability. In the case of chronic neck pain, changes in the pain threshold cause central sensitisation and individuals become more sensitive to pain stimuli. This situation can affect the processing of proprioceptive information and lead to deterioration in proprioceptive perception. This situation leads to perceptual problems in body and neck awareness. Therefore, examining the relationship between the relevant parameters is important in the rehabilitation process. In this context, the aim of the study is to examine the relationship between body awareness and pain, central sensitisation, disability and proprioception in patients with chronic non-specific neck pain.
Read the detailed description
Chronic neck pain is a common pain problem related to the musculoskeletal system and can lead to permanent (chronic) disability over time. In approximately 50-85% of individuals with neck pain, complaints do not completely improve despite treatment, causing the pain to become chronic. Individuals with chronic neck pain have difficulty performing various activities in their daily lives, and this negatively affects their quality of life. Proprioceptive feedback in the neck region, that is, sensory information that allows the body to perceive its position in space, is very important for proper control of head and neck movements. However, chronic pain can lead to a condition called central sensitization. In this case, the individual's pain threshold decreases and they become more sensitive to stimuli that would normally not cause pain. This increased sensitivity can make it difficult for the brain to process proprioceptive information correctly, which can lead to impairments in body and neck awareness. Therefore, investigating the relationship between body awareness and pain level, central sensitization, disability status and proprioception in individuals with chronic non-specific neck pain is of great importance in terms of developing an effective rehabilitation program.
- Conditions
- Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Higher sensitization | It will consist of patients who exceed the cut-off score according to the central sensitization scale score. | |
| Normal sensitization | It will consist of patients with a central sensitization scale score lower than the cut-off score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central sensitization
It will be evaluated with the "Central Sensitization Scale". The scale is scored between 0-100 and 40 points and above is recorded as sensitive.
Measured: Baseline
Pain severity
Pain intensity will be assessed with the Numerical Pain Scale. It is scored between 0-10 and the higher the score, the greater the pain intensity.
Measured: Baseline
Pain threshold
Pain threshold will be assessed with an algometer. An increase in the applied pressure indicates a higher pain threshold.
Measured: Baseline
Neck disability
Neck disability will be evaluated with the index. It varies between 0-50 points and the higher the score, the higher the disability.
Measured: Baseline
Proprioception
Proprioception will be recorded as the degree of deviation with the CROM device. As the degree of deviation increases, proprioception worsens.
Measured: Baseline
Body awareness
Body Awareness Questionnaire (BAF) will be used. It varies between 18-126 points and as the score decreases, awareness decreases.
Measured: Baseline
Neck awareness
It will be assessed with the Fremantle Neck Awareness Questionnaire. It varies between 0-36 and as the score increases, awareness decreases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 May 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Gunes, PhD, Study director, Karabuk UniversityMelek Turan, Principal investigator, Karabuk UniversityDuygu Çataloluk, Principal investigator, Karabuk UniversityAydın Sinan Apaydın, PhD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976398
- Sponsor's protocol ID
- Karabuk-2281
- Status last verified
- Apr 2026
- First submitted
- 2 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Maas LC, Koke A, Bosscher RJ, Twisk JW, Janssen TW, Peters M. Body Awareness as an Important Target in Multidisciplinary Chronic Pain Treatment: Mediation and Subgroup Analyses. Clin J Pain. 2016 Sep;32(9):763-72. doi: 10.1097/AJP.0000000000000320.
PubMed 26550959Williams DA. Phenotypic Features of Central Sensitization. J Appl Biobehav Res. 2018 Jun;23(2):e12135. doi: 10.1111/jabr.12135. Epub 2018 Jun 27.
PubMed 30479469Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.
PubMed 27327235Gunes M, Turan M, Cataloluk D, Apaydin AS. The relationship between neck and body awareness, pain, and proprioception with central sensitization in patients with chronic nonspecific neck pain. BMC Musculoskelet Disord. 2026 Feb 14;27(1):231. doi: 10.1186/s12891-026-09628-w.
PubMed 41688976
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Central Sensitisation in Patients With Chronic Non-spesific Neck Pain
- ClinicalTrials.gov ID
- NCT06976398
- Acronym / sponsor ID
- Karabuk-2281
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 16 May 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.
Chronic neck pain is one of the musculoskeletal pain problems that can cause chronic disability. It is emphasised that individuals with chronic neck pain have difficulty during different activities in their daily lives, and that this problem is a very common health problem that can lead to disability. In the case of chronic neck pain, changes in the pain threshold cause central sensitisation and individuals become more sensitive to pain stimuli. This situation can affect the processing of proprioceptive information and lead to deterioration in proprioceptive perception. This situation leads to perceptual problems in body and neck awareness. Therefore, examining the relationship between the relevant parameters is important in the rehabilitation process. In this context, the aim of the study is to examine the relationship between body awareness and pain, central sensitisation, disability and proprioception in patients with chronic non-specific neck pain.
Detailed description
Chronic neck pain is a common pain problem related to the musculoskeletal system and can lead to permanent (chronic) disability over time. In approximately 50-85% of individuals with neck pain, complaints do not completely improve despite treatment, causing the pain to become chronic. Individuals with chronic neck pain have difficulty performing various activities in their daily lives, and this negatively affects their quality of life. Proprioceptive feedback in the neck region, that is, sensory information that allows the body to perceive its position in space, is very important for proper control of head and neck movements. However, chronic pain can lead to a condition called central sensitization. In this case, the individual's pain threshold decreases and they become more sensitive to stimuli that would normally not cause pain. This increased sensitivity can make it difficult for the brain to process proprioceptive information correctly, which can lead to impairments in body and neck awareness. Therefore, investigating the relationship between body awareness and pain level, central sensitization, disability status and proprioception in individuals with chronic non-specific neck pain is of great importance in terms of developing an effective rehabilitation program.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher sensitization | – | –It will consist of patients who exceed the cut-off score according to the central sensitization scale score. |
| Normal sensitization | – | –It will consist of patients with a central sensitization scale score lower than the cut-off score. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non-specific neck pain will be included.
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Being diagnosed with chronic non-specific neck pain by a doctor
- Being willing to participate in the study
Key exclusion criteria (6 listed)
- Having psychological disorders, mental disorders, cancer and severe depression
- Having a history of traumatic injury
- Having a history of primary or metastatic spinal malignancy, spinal fracture
- Having a neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
- Having been diagnosed with advanced osteoporosis
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
Central sensitization
Time frame: Baseline
It will be evaluated with the "Central Sensitization Scale". The scale is scored between 0-100 and 40 points and above is recorded as sensitive.
Pain severity
Time frame: Baseline
Pain intensity will be assessed with the Numerical Pain Scale. It is scored between 0-10 and the higher the score, the greater the pain intensity.
Pain threshold
Time frame: Baseline
Pain threshold will be assessed with an algometer. An increase in the applied pressure indicates a higher pain threshold.
Neck disability
Time frame: Baseline
Neck disability will be evaluated with the index. It varies between 0-50 points and the higher the score, the higher the disability.
Proprioception
Time frame: Baseline
Proprioception will be recorded as the degree of deviation with the CROM device. As the degree of deviation increases, proprioception worsens.
Body awareness
Time frame: Baseline
Body Awareness Questionnaire (BAF) will be used. It varies between 18-126 points and as the score decreases, awareness decreases.
Neck awareness
Time frame: Baseline
It will be assessed with the Fremantle Neck Awareness Questionnaire. It varies between 0-36 and as the score increases, awareness decreases.
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 22 Apr 2026.
- Background: PubMed 26550959van der Maas LC, Koke A, Bosscher RJ, Twisk JW, Janssen TW, Peters M. Body Awareness as an Important Target in Multidisciplinary Chronic Pain Treatment: Mediation and Subgroup Analyses. Clin J Pain. 2016 Sep;32(9):763-72. doi: 10.1097/AJP.0000000000000320.
- Background: PubMed 30479469Williams DA. Phenotypic Features of Central Sensitization. J Appl Biobehav Res. 2018 Jun;23(2):e12135. doi: 10.1111/jabr.12135. Epub 2018 Jun 27.
- Results publication: PubMed 27327235Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.
- Derived from this study: PubMed 41688976Gunes M, Turan M, Cataloluk D, Apaydin AS. The relationship between neck and body awareness, pain, and proprioception with central sensitization in patients with chronic nonspecific neck pain. BMC Musculoskelet Disord. 2026 Feb 14;27(1):231. doi: 10.1186/s12891-026-09628-w.
- 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.
Musa Gunes, PhD study director
Karabuk University
Melek Turan principal investigator
Karabuk University
Duygu Çataloluk principal investigator
Karabuk 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, run by Karabuk 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 3 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 22 Apr 2026. 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?
Central sensitization (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976398, which also lists 4 linked publications.
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 22 Apr 2026.